2015

KOREA INNOVATIVE
PHARMACEUTICAL
COMPANY
 Potential of Pharmaceutical Industry in Korea

Aging populations and growing interest in health and welfare continue to

drive up the demand for innovative drugs across the world. Globally, R&D
spending in the pharmaceutical industry was higher than any other industry
(pharmaceutical and bio ranked No. 1 with KRW 126 trillion, according
to the data released by Department for Business, Innovation and Skills
in UK), indicating that the future industrial structure is shifting from IT to
pharmaceutical business.

Pharmaceutical Industry in Korea

In Korean wons, the value of drugs manufactured in Korea was KRW 16.3 trillion in 2013. The annual average
growth rate for the past five years was 2.6 percent. In addition, the size of the pharmaceutical market was
KRW 19.3 trillion in 2013.

Size and Market Trends in Pharmaceutical Industry in Korea (Unit: KRW Trillion, %)
Category Production Export Import Balance Market size YoY Growth Rate
2009 14.8 1.8 5.2 △3.4 18.2 6.02
2010 15.7 1.8 5.4 △3.6 19.3 6.18
2011 15.6 1.9 5.5 △3.6 19.1 -0.94
2012 15.7 2.3 5.9 △3.5 19.2 0.32
2013 16.4 2.3 5.3 △2.9 19.3 0.57

Note: 1) P harmaceutical products include finished products, narcotic drugs, ultra narcotic, psychotropic substance and drug substance
2) Numbers in export and import categories are calculated in Korean won and converted US dollar by using annual average exchange rate at Bank of Korea
Source: 2013 Pharmaceutical Industry Statistics, Korea Pharmaceutical Manufacturers Association (KPMA)
Facts & Survey Report, 2013, Korea Pharmaceutical Traders Association (KPTA)

Based on its technological competitiveness and quality drugs, the pharmaceutical industry in Korea has
taken a stride in strengthening its ability to develop innovative drugs in a short period of time, including R&D,
clinical trials and drug manufacturing. Impressive growth made in the last few years suggests that Korea-
based pharmaceutical companies are ready to take a leap forward as global players.

[R&D] Development of innovative medicines and strong pipelines across various

therapeutic areas

The local pharmaceutical industry began to manufacture both finished products and drug substances in the
1960s, and developed new processes in the 1980s. Following the early phase of drug development in the late
1980s, Korean pharmaceutical industry began to develop innovative drugs in the 2000s, and has successfully
developed some innovative and incrementally modified drugs since then.
Since the introduction the chemical compound patent system in 1987, the number of innovative drugs
introduced in the country has also increased at a very fast pace. Korea has seen development of innovative
drugs across various therapeutic areas, from “Sunpla Injection,” a treatment for stomach cancer developed
by SK Pharmaceuticals in 1999 to “Sivextro” developed by DONG-A ST in 2015. So far, Korean pharmaceutical

2
companies have developed therapies in an array of areas including oncology, antibacterial, gastritis, respiratory
infections, duodenal ulcer, diabetic foot ulcer, erectile dysfunction, hepatitis B and hypertension.

Development of
innovative drugs targeting
Drug development the global market
Early years of drug getting on track
development 2010’s
Local manufacturing of Development of
new processes 2000’s
finished products and
drug substance 1990’s
1980’s
1960/70’s

Launch of innovative drugs (total of 23)

’99 ’01 ’02 ’03 ’05 ’06 ’07 ’08 ’10 ’12 ’13 ’14 2015

Sunpla EGF Factive Apitoxin Revanex Levovir Pelubi Noltec Pyramax Supect Duvie Riavax Acelex

Milican Peudovaccin Zydena Mvix Kanab Zemiglo Zabolante

Q-roxin Camtobell Zepeed Sivextro(Tab.)

Sivextro(Inj.)

Drug Development in Korea

[Clinical Trials] Clinical trials grew dramatically from both qualitative and quantitative
perspectives

Already on a clear growth track with its high level of clinical trial capabilities and reliable data, Korea is emerging as
a core clinical trial destination in the pharmaceutical market in Asia. Seoul-based 13 major healthcare organizations,
including Seoul Nat’l University Hospital, Samsung Seoul Medical Center and Asan Medical Center, have won global
certifications for their clinical study environment helping the country to build a clinical infrastructure on a global level.
With this advanced infrastructure, Seoul became the third largest host city for global clinical trials, following Houston
and San Antonio in the United States, in 2009. Seoul was also selected as Asia’s No. 1 destination for clinical trials
in 2008 (338 cases in Korea, 135 in Singapore and 36 in Japan).

The number of multinational regional clinical trials (MRCTs) conducted by multinational pharmaceutical companies
in Korea has also increased sharply since the country introduced International Conference on Harmonization Good
Clinical Practice (ICH GCP) in 2000. Especially, Pfizer formed a partnership with Korea as part of its global clinical
program in 2008, selecting 4 of its 9 global Core Research Sites (CRSs) in Korea.

[Manufacturing] High level of competitiveness and ability to generate rich pipelines of

innovative drugs

Pharmaceutical companies in Korea have been working to ensure that their drug manufacturing facilities meet
rigorous global standards. To reflect global trends, the guidelines on Good Manufacturing Practices (GMP) changed
from dosage forms to prior approval of individual items in 2008. As the guidelines shifted from management of

3
 dosage forms to that of individual items based on a step-by-step process through 2010, the quality assurance
system for domestically manufactured drugs reached a global level.

In addition, Korea has the ability to conduct drug R&D for compounds and commercial technologies, including
organic synthesis, agents and global clinical trials. This ability was gained through development of generics
and incrementally modified drugs. Korea is also a leader in the pharmaceutical biological technology area. With
fruitful results from R&D including development of the world’s first stem cell therapy and xenotransplantation
of pancreatic ducts, Korea is in an advantageous position to be a leader in promising future industries. The
level of therapeutic technologies in cardiac surgery and management, and cervical cancer in Korea is the best
among other OECD countries, according to OECD Health Data 2009.

Korea pharmaceutical industry is shifting its focus from the domestic market to the global market, and the world
now pays attention to Korean pharmas as successful partners.

Korean Pharmaceutical Market National Pharmaceutical R&D Support

KRW 19 Trillion(USD 17 Billion, ‘13)
▶ Total government healthcare R&D : $400M
▶ 2% of the World Market (13th) ▶ Total government pharm. R&D : $250M
▶ Total MoHW pharm. R&D : $130M
▶ Around 5.9% Average Annual Growth (’07 to ’12)

▶ Only 25% MNC dominated

(reimbursement price based, ’12)

▶ 680 Manufacturers (257 for finished drugs) Clinical Trial Capability
▶ S eoul, the capital of South Korea, ranks #1 for industry
New Drug Release Competency sponsored clinical trials among all cities worldwide (2013)
▶ Korea ranked as 10th in the world for Industry sponsored

clinical trials
▶ 20 New Drugs, 33 IMD products approved
▶ 2~3 New drugs coming out to the market every year
World Class GMP & DDS Technology
Top Class Bio-Pharma Competency ▶ cGMP & EU GMP standard facilities
▶ Innovative Drug Delivery Systems
▶ High quality bio products (1st stem cell therapy, 1st • F ilm-type Viagra and patch-type Alzheimer's and Parkinson’s
biosimilar approved, 20 biosimilar clinical trials undergoing) drugs developed, etc
▶ S tem cell (Clinical trials 2nd, Patent 4th,

# of Researcher 5th, SCI Papers 8th in the world)

▶ Stable supply of Vaccines High Growth in Export
• Self supply for essential vaccines
• 5 premium vaccines in Clinical Trials ▶ ’08~’12, 16.5% CAGR for Drug Export
(Phase 1, (PCV, HPV, Rotavirus, Herpes zoster, Cholera)) • US $2,300 M export (’12)

Plant Construction Globalization

▶ C onstruction of pharma clusters in Saudi Arabia and UAE ▶ Joining PIC/S (expected in July, 2014)
based on G2G cooperation under discussion ▶ 20 WHO PQ products developed (’13)
• The countries want K-Pharmas to participate in their pharma • 13 vaccines, 3 drugs, 4 diagnostic reagents
cluster projects ▶ J oint worldwide marketing of K-pharma developed drugs
• ‘Cloning Project’ : 
SA wants to build exactly same anticancer with MNCs
plant as K-pharma’s one • Boryung’s Kanarb® for hypertension (Fimasartan)
▶ IV Solution Plant of JW Pharm • Celltrion’s Remsima® Inj. (Inflixmab)
• Hanmi’s Amosartan® for hypertension and
• Plant Construction Order in Kazakhstan
• Esomezol® for esophageal reflux disease
▶ Blood Fractionation Plant of Green Cross Corp
• JW’s 3 chamber IV solution
• Contract with the Thai Red Cross

4
Public-private Partnership for Development of Pharmaceutical Industry
Contributing to Global Health

Korea aspiring to transforming itself into one of the top seven pharmaceutical powerhouses
Korea has designated the pharmaceutical industry as one of the future growth engines. In order to foster the industry,
the Korean government has been placing emphasis on enhancing growth potential through far-reaching policy
measures, ranging from technology innovation to promoting market transparency, boosting global competitiveness
of companies, and establishing infrastructure for sustainable development. Moreover, with knowledge and capacity
mustered, the government, industry, medical society, and academic community are devoting themselves to make a
leap forward into global markets.

Under the circumstance where the Korean population has been aging rapidly, the Korean government has keen interest
in the pharmaceutical industry, which serves as a foundation for the quality of life of the public. The government
introduced “Accreditation of Innovative Pharmaceutical Company” in 2012, and will reinforce its efforts to support the
industry every year with a view to reinventing the nation into one of the top seven pharmaceutical titans.

Introduction of Promotion and Support of Innovative Pharmaceutical Company

What Company Can Be an Innovative Pharmaceutical Company?
Special Act on Pharmaceutical Industry Promotion and Support (enacted in March 2011) serves as the legal foundation to
designate innovative pharmaceutical companies verified to possess high R&D capacity for new drug development and to
be globally competitive. Those companies are expected to play a leading role in developing the domestic pharmaceutical
industry into a future growth engine.

Accreditation Process
The Accreditation Screening Committee conducted written and verbal evaluations on candidate pharmaceutical firms
which met the requirements (Article 2 of the Enforcement Decree of the Special Act: investment volume over a certain
level). In the evaluations, the committee assessed candidate companies based on specific requirements, such as R&D
performance in the past, company’s capacity, vision and investment plan, ethical business practice, etc. The results of
the evaluations delivered by the screening committee were finalized after the review carried out by the Committee for
Pharmaceutical Industry Promotion and Support, which is chaired by the Minister of Health and Welfare.

Composition of Designated Innovative Pharmaceutical Companies

• 3 1 general pharma firms: 31 leading firms that have marked high scores in terms of R&D investment as well as researchers,
manufacturing facilities, patent and license-out, and overseas market advancing plus ten SMEs that have built on expertise
in specialized areas such as development of incrementally modified drugs
•S  even bio venture companies: firms with relatively low sales but highly competitive technology and creative business models
• Two local corporations of a multinational pharma firm: one local company of an MNC considered outstanding
in terms of R&D investment (in early clinical trials), local production performance, overseas market advancing, etc.

List of Companies Certified as Innovative Pharmaceutical Companies [40]

Category Name of Company
Ahngook pharm.co.Ltd, Boryung Pharmaceutical co., Ltd., Bukwang Pharmaceutical Co., Ltd., Celltrion,
Inc., Chong Kun Dang Pharmaceutical Corp., CJ HealthCare corporation, Dae Hwa Pharmaceutical
Co. Ltd., Daewon Pharmaceutical Co., Ltd., Daewoong Pharmaceutical Co., Ltd., Dongkook
Pharmaceutical, Green Cross Corp., HanAll BioPharma Co. Ltd., HANDOK Inc., HANLIM PHARM. CO.,
General pharma firms [31] LTD., Hanmi Pharmaceutical. Co., Ltd., HUONS CO., LTD., Hyundai Pharmaceutical Co., Ltd., IL-YANG
PHARMACEUTICAL CO., LTD., ISU ABXIS, JW Pharmaceutical Corp., Kolma Korea Co., Ltd., Korea United
Pharm. Inc., Kuhnil Pharmaceutical Co.,Ltd, LG Life Sciences, Ltd., Samjin Pharmaceutical Co., Ltd.,
Samyang Biopharmaceuticals Corporation., SHIN POONG PHARM. CO., LTD, SK Chemicals Co. Ltd., ST
Pharm Co., Ltd., TAEJOON PHARM. CO., LTD., Yuhan Corporation
BCWORLD PHARM. CO., LTD., BIONEER CORPORATION, CrystalGenomics, Inc., GemVax & KAEL Co., Ltd.,
Bio venture companies [7]
Genexine, Inc., Medytox, ViroMed Co., Ltd
Local corporation of a
Korea Otsuka Pharmaceutical Co.,Ltd., sanofi-aventis Korea
multinational pharma firm [2]

5
Pharmaceutical

For a Better Life

Ahngook pharm.co.Ltd

The 50 years old leading R&D oriented Korean pharmaceutical manufacturer/

Distributor/Exporting/licensor company.
Mainly focusing on Respiratory/GI/Cardio/NSAID. Nominated as one of the leading innovative R&D company in
Korea by government. A variety of licensing/importing opportunity (New Antitussive/Expectorant, Modified GI
modulator/Chiral PPI tablet form, Syrup type Dexibuprofen and so on)
Ahngook pharm is the top respiratory field market leader in Korea with Synatura syrup and Anycough cap.
Not only Ahngook has been focusing on respiratory syrup but also big market player in cardiovascular field with
Levotension (S-amlodipine tablet). Also, Ahngook has been launching new and differentiated drugs in the market
with strong R&D capability.
Ahngook’s financial status is very sound and stable with sound cash flow and profit.
Likewise, Ahngook is one of the most promising pharmaceutical companies in Korea.

Brief Company Profile

· Founded in 1959 · HQs is located in Seoul
· Main Business areas : · Central Reseach Center and General Plant are
Pharmaceuticals, Diagnostic Medical Devices, located in Gyeonggi-do
Cosmetics and Export · Representatives
· Sales : KRW 121 Bil.(USD 110 M in 2011) - Mr. June-Sun Auh : Chairman
Synatura Syrup
· Employees : 471 Persons - Mr. Jin Auh : CEO & President

Brief History of Ahngook

Year Milestones
1959 Established
Anycough Cap.
1969 Mr. June-Sun Auh joined as President
1986 Completion of the Korea GMP Facility
1994 Launching of Tobicom-s(Eye-nutrient) / Selected as ‘the HIT product’ of the year
1998 Mr. Jin Auh was named CEO & President
2000 Launching of Prospan and Listed on KOSDAQ
2005 Approval of BGMP synthetic Facility by KFDA
Levotension Tab.
2006 Launching of Levotension (the first S-amlodipine in Korea) for the treatment of hypertension
Groundbreaking of New GMP facilities
2009 “Anycough”(Novel Antitussive) was launched in July, 2009
50th Anniversary ceremony held
2010 Out-licensing of Anycough to Biocopea (UK), June 7th. 2010
Launching of Synatura, new herbal formulation
2011 Co-Promotion agreement for Zaditen of Novartis Korea
Co-Promotion agreement for Harnal-D(BPH) and Vesicare(OAB) of Astellas Korea
Letopra Tab. In-licensing of Lupapin & Export MOU of Synatura
2012 Nominated as ‘the innovative pharmaceutical company’ by Korean Ministry of Health.

CONTACT US
James S.Y.Cheon · Company Ahngook pharm.co.Ltd
Vice President / Global Business Division · CEO Jin Auh
• Phone : +82-2-3289-4348 · Specialty Pharmaceutical Manufacturer, Distributor, Exporter
• Fax : +82-2-849-4123 · Location 993-75, Daelimdong, Yongdeungpo, Seoul, Korea
• E-mail : [email protected] · Homepage www.ahn-gook.com

6
 Pharmaceutical
Towards Global Standard R&D for Healthcare Products
BCWORLD PHARM. CO., LTD.

BCWORLD PHARM is a technology-driven pharmaceutical company in

Korea whose expertise in formulation and process development enables
it to provide quality generics as well as value-added novel formulation
products.
BCWORLD PHARM strives to establish its position as a pioneer in developing value-added pharmaceuticals
through cutting-edge formulation technology including immediate/controlled release as well as fast-dissolv-
ing DDS, combined formulation, gastro-retentive system and depot formulation by way of proactive invest-
ments in R&D and strategic alliances.

Recently BCWORLD PHARM not only has been certified as Korea Innovative Pharmaceutical Company (KIPC)
by Korea Ministry of Health & Welfare but also designated as Advanced Technology Center (ATC) by Korea
Ministry of Knowledge Economy.

Main Products
Therapeutic Class Products
Antibiotics (Carbapenem) Mepem Inj., Cilacin Inj. etc.
CILACIN INJ. Anti-Infectives Merogel Gel, BC Itraconazol Tab., etc.
Hyperlipidemia Starova Tab., BC Atorvastatin Tab. etc.
Anti-Osteoporosis Agents Pamiron Inj., Risidro Tab.
Anti-Hypertensives Ibertan Tab., Ibertan Duo Tab., Duomax Tab. etc.
GI Agents Mucopid Tab., BC Ranitidine Inj. etc.
Narcotics Remiba Inj., BC Morphine Sulfate Inj., BC Fentanyl Inj. etc.
MEROGEL

R&D Pipeline
Category Item Indications Stage
PAMIRON INJ.
GRS BCWP_A001 Antibiotic Phase I (Korea)
Combination BCWP_C001 Hyperlipidemia Preclinical
Microsphere BCWP_D001 Anti-cancer Formulation
Microsphere BCWP_D003 Anti-cancer Preclinical
Microsphere BCWP_D009 Schizophrenia Preclinical
CONTACT US
Microsphere BCWP_D011 Diabetes Formulation
David Kim, Director SR BCWP_E003 Psychostimulant Formulation
Overseas Business Department SR BCWP_E004 BPH Preclinical
• Phone : +82-2-2182-0466 Prodrug BCWP_P001 Anti-cancer Preclinical
• E-Mail : [email protected]
• Head Office : 78 Gaepo-ro 22gil Liposome BCWP_Y001 Anti-cancer Formulation
Gangnam-gu, Seoul, Korea

Myung-Kwan Chun, PhD., Director

Research Planning Team
• Phone : +82-31-628-0921 · Company BCWORLD PHARM. CO., LTD.
• E-Mail : [email protected] · CEO Steve H. Hong
• GRI : A-3, Korea Bio Park, · Specialty · DDS-oriented Pharmaceutical Company
· Therapeutic categories such as pain, anesthesiology,
694-1 Sampyeong-dong, neurology, and musculoskeletal diseases
Bundang-gu, Seongnam-si, · Location 78 Gaepo-ro 22gil Gangnam-gu, Seoul, Korea
Gyeonggi-do, Korea · Homepage www.bcwp.co.kr

7
Pharmaceutical

A Leading Biotech Company

BIONEER CORPORATION

Bioneer, an innovative biotech company since 1992

Leadership in RNAi Therapeutics:
Bioneer Corporation is Korea’s leading biotech company. Bioneer was the first Korean biotechnology company when
it was established in 1992. The company has developed state of art molecular biology products and technologies
including oligonucleotides/siRNA and instruments of gene manipulation. The company is positioned to fully-
integrate its capability to develop next generation technologies in the post-genome era through the invention of
new biochemistry and instruments. By capitalizing on the foundational technologies and products developed over
10 years, Bioneer has developed a solid vertically integrated infrastructure to support new higher value-added
businesses such as novel RNAi drug development and molecular diagnostics.

Bioneer’s siRNA Drug Development Program using SAMiRNATM Technology

SAMiRNA (Self-Assembled-Micelle-inhibitory-RNA) is a novel class of RNAi molecule, developed by Bioneer,
which allows efficient and safe in vivo delivery of siRNA to target tissues. SAMiRNA is a SCE (single Chemical
Entity), which is manufactured using a proprietary process that greatly simplifies the manufacture and QC
process relative to other state-of-the-art RNAi delivery platforms. SAMiRNA overcomes major challenges for
safe and effective siRNA delivery as well as adverse effects of delivery vehicle. Other advantages of SAMiRNA
include its flexibility to incorporate siRNA sequences against any disease target, as well as enhancement of
its therapeutic potential as a delivery platform through the use of cell-type specific targeting ligands. These
features and pre-clinical research data suggest that SAMiRNA is the most unique and singularly effective RNAi
prodrug system developed to date.
Vertically integrated processes within Bioneer’s siRNA Drug Development Program provide a total solution for
siRNA therapeutics discovery and development, from siRNA design/synthesis and preclinical tests to IND filing.
With its world’s-best RNAi core technologies and manufacturing infrastructure, Bioneer is the ideal partner for
pharmaceutical and biotechnology companies currently working on the development of RNAi therapeutics, or
seeking to enter the RNAi field. Bioneer’s research and technical support teams ensure top-quality products and
services to meet your unique needs.

R&D Pipeline
Bioneer is currently advancing clinical development of pipeline programs for previously non-druggable targets,
including cancer, IPF/COPD, liver fibrosis, and antivirals, internally with our research and development resources
as well as through partnerships with major global pharmaceutical companies.
Clinical Trials
Programs Discovery Development Preclinical
Phase I Phase II Phase III
BIONEER PROGRAMS
Solid Cancers
(SAMiRNA-Survivin)
IPF/COPD
Liver Fibrosis
Antivirals
PARTNER PROGRAM
Liver Cancer
SANOFI

CONTACT US · Company BIONEER CORPORATION

· CEO Han-Oh Park, Ph.D.
Joo-Sung Yang, Ph.D., Head of New · Specialty Molecular Diagnostic, Genomic New Drug, Genomic Science,
Drug R&D Center Synthetic Vaccine
• Phone : +82-42-930-8670 · Location 49-3, Munpyeong-dong, Daedeok-gu, Daejeon 306-220, Korea
• E-Mail : [email protected] · Homepage www.bioneer.com

8
 Pharmaceutical
Total Healthcare Company Contributing to the Human Health
Boryung Pharmaceutical co., Ltd.

Boryung Pharmaceutical company (here after Boryung), since founded

in 1963, has been trying its best to contribute to the health and well-being
of humanity with corporate mission to ‘realize mutual health and co-
prosperity based on human centered values’.
Boryung has invested continually on research and development and made continuous efforts to produce high-
quality products in the specialty areas such as cardiovascular, antineoplastic and antibiotics drugs. As a result,
our products such as Gelfos M, Yongkaksan and Kyushin have become the best selling products and Boryung
has emerged as the most familiar and trusted brand in Korea.

Products
Kanarb® (Fimasartan)
Boryung has developed Kanarb® by our proprietary technology. Kanarb is an innovative anti-hypertensive drug
that has been approved by the KFDA as the 15th new drug in 2011, also it is 8th new ARB in the world. It was
also awarded with ‘Korea Technology Awards’ by the Ministry of Knowledge Economy and ‘Oh Song New
Drug Prize’ by the KFDA in 2011. Kanarb is the best selling ARB in Korea and has USD 30 million sales in 2014.
Until now, Boryung has successfully licensed-out Kanarb® with Mexico and 12 other Latin countries, Brazil,
Molecular Structure
Russia and China and launched in Mexico September of last year. Also we are under business licensing
discussions with Japan, USA, Europe, Australia etc.
Kanarb Combination drugs
Boryung has been developing Kanarb combination drugs (BKC002, BKC003, BKC004, BKC007) for more severe
patients who are suffering from hypertension, hyperlipidemia, heart failure and diabetes mellitus. For these
combination drugs, we are under business licensing discussions with Kanarb® licensed-out companies and
seeking potential partners for oversea markets.
60mg fimasartan

R&D Pipeline
Category Therapeutic area Indication Product RS PC PI PII PIII RG Launch
Hypertension BKC 001 ○
120mg fimasartan Hypertension BKC 002 ○
CV Hypertension Hyperlipidemia BKC 003 ○
IMD
Hypertension Hyperlipidemia BKC 004 ○
Hypertension Hyperlipidemia BKC 007 ○
CNS Alzheimer's disease BNT 002 ○
Vaccine BVN 001 ○
Vaccine BVN 002 ○
Biologics
Vaccine BVN 003 ○
Liver cancer BCB 002 ○

Contact Information
· Company Boryung Pharmaceuticals co., Ltd.
Ji Hyun Min · CEO Tae Hong, Choi
R&D stratergic planning · Specialty Full ingredient Pharmaceutical product and substance
• Phone : +82-2-740-4019 · Head Office 136, Changgyeonggung-ro, Chongro-ku, Seoul
• E-mail : [email protected] · Homepage www.boryung.co.kr

9
Pharmaceutical

To Contribute to Society through Supplying Value-added New Products to

Help Patients Suffering from disease
Bukwang Pharmaceutical Co., Ltd.

Bukwang Pharmaceutical Co., Ltd. is one of the innovative pharmaceutical

companies in Korea and was founded in 1960 with dedication to development
and commercialization of novel, outstanding medicines.
Bukwang has successfully achieved remarkable growth for over fifty years. Now Bukwang has 520 employees or
so, with over 180 billion Korean won of net sales in fiscal year 2010.

Through many years of effort, ‘Levovir® cap. (clevudine)’, the 4th drug worldwide for hepatitis B virus, was finally
approved by KFDA in 2006, and it is the 11th New Drug developed in Korea. Levovir® was licensed out to Eisai, a
Japanese company, and they paid 44 million dollars for the license of clevudine in Asian countries including China.

Bukwang reinvests a part of its profit for continual development of new products. Several projects for developing
new medicines are ongoing in the R&D center.

Bukwang will use its novel tools and technologies to attain a prominent market position in the pharmaceutical
industry field, increasing its business profitability and the value of the company while providing effective new
solutions to incurable diseases and fundamental biological processes.

Products
Levovir® cap.(clevudine) : an innovative new drug for chronic hepatitis B virus)
Levovir was developed by Bukwang and it is the 4th drug developed for HBV infection worldwide, and the 11th new
Levovir
drug in Korea. It is potent in suppression of hepatitis B virus and it has excellent safety and tolerability profiles.

R&D Pipeline
Targeted anti-cancer agent (apatinib mesylate)
- Phase III clinical trial for colorectal cancer and lung cancer completed in China
- Phase I/II approved in USA as well as in Korea

Antivirus drug for hepatitis B virus

- Combination drug of clevudine and adefovir dipivoxil to maximize the effectiveness of treatment and to inhibit
resistant virus reciprocally
- New drug: gained development right for prodrug and exclusive sales rights worldwide from Georgia University, USA.
Novel antivirus drug for Herpes Zoster
- License agreement of a new substance called “L-BHDU”
- New synthetic substance collaborated by Georgia and Yale University, USA

Diabetic neuropathy drug

- New drug using only a stereoisomer of thioctic acid
- Completed phase III trial

CONTACT US
· Company Bukwang Pharmaceutical Co., Ltd.
Choi, In Ae · CEO Lee, Sung Koo
Product Development · Specialty Pharmaceuticals and sanitary aids
• Phone : +82-2-8288-078 · Location 398-1, Daebang-dong, Dongjak-gu, Seoul, Korea
• E-mail : [email protected] · Homepage http://www.bukwang.co.kr

10
 Pharmaceutical
A Global Technology Leader in the Field of
Biosimilar and Biologic Drug Development
Celltrion, Inc.

Celltrion's goal is to provide affordable alternatives to the high-priced

antibody drugs, price of which limits broad usage of the drugs.
Celltrion prides itself in being the first company in the world to apply for global regulatory approval of an
antibody biosimilar. We are using our accumulated R&D technology and manufacturing capabilities to develop,
manufacture and market antibody biosimilars and innovative drugs to patients in need. Celltrion hopes that more
suffering patients will be able to have access to and benefit from the new availability of advanced biomedicines.

Products
Remsima™ (infliximab) is the world’s first biosimilar mAb to receive positive opinion from an advanced and
developed nations’ regulatory body, which is a monoclonal antibody against tumor necrosis factor alpha (TNF-α)
used to treat autoimmune diseases like ankylosing spondylitis, rheumatoid arthritis, Crohn’s Disease, ulcerative
colitis, psoriasis and psoriatic arthritis. The European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) had given positive opinion for Celltrion-developed Remsima™ for sale in the
European Union (EU) in June 2013. With this positive CHMP opinion, Celltrion is permitted to obtain marketing
authorization approval (MAA) from 27 EU countries and 3 EEA (European Economic Area) countries (for a total of
30 countries) through simple administrative procedures. Remsima has already received approval from the MFDS
(former KFDA) in July, 2012.
Global launch of Remsima™ is remarkably good news for patients who previously had limited access to
advanced therapeutics, in particular, those hindered by the high cost of antibody biopharmaceuticals. We
believe that the first biosimilar mAb approval by the EMA will spearhead the start of a new era of biosimilar
mAbs in the pharmaceutical industry. Celltrion, Inc. also has gained entry into the $24 billion TNF-α antagonist
market and is likely to be the only biosimilar product in the market for the next 4 to 5 years.

R&D Pipeline
Celltrion currently has 8 biosimilars candidates in various stages of development. The CT-P6 (Breast Cancer) Project
is in their most advanced stages of development, successful completion of clinical trials conducted in over twenty
countries and completed submission for approval in Korea.
PROJECT CT-P06
- Indication: Metastatic and early breast cancer that over express HER2 gene (Protein Type: mAb)
PROJECT CT-P10
- Indication: Rheumatoid arthritis, Non-Hodgkin’s lymphoma (Protein Type: mAb)
Remsima™ As a company specialized in antibody drug development, Celltrion is also developing innovative antibody drug
(PROJECT CT-P27) to overcome the limitations of existing vaccines and synthetic drugs for pandemic or seasonal
influenza viruses. Celltrion received IND approval from England’s Medicines and Healthcare products Regulatory
Agency (MHRA) to initiate a phase 1 clinical trial for CT-P27, an influenza antibody shown to have efficacy for
pandemic and seasonal flu strains, including various subtypes of influenza viruses. The results of animal tests
conducted by the US Center for Disease Control and Prevention showed that this new antibody drug may be
effective in treating avian influenza, influenza A and many other variationsof influenza viruses. Thus, this new drug
is expected to become the world’s first comprehensive influenza virus treatment antibody, if succeeded.
Additionally, Celltrion is developing innovative drug to cure rabies by collaborrating with the US Center for Disease
Control and Prevention. Celltrion is also working with a US biotech company to develop an antibody drug that
is expected to be a cure for breast cancer and lung cancer. Other than the antibody drugs pipeline, Celltrion is
CONTACT US focusing on developing antibody-drug conjugate that minimizes side effects and maximizes efficacy by integrating
antibodies with synthetic drug substances. Celltrion’s broad innovative drug pipeline is expected to serve as the
Celltrion Headquarters driving force behind Celltrion’s future growth.
• Phone : +82-32-850-5008
• Fax : +82-32-850-5057 · Company Celltrion, Inc.
• E-mail · CEO JungJin Seo
Business : [email protected] · Specialty biopharmaceutical development and manufacture
Investment : [email protected] · Head Office 13-6, Songdo-dong, Yeonsu-gu, Incheon, 406-840, South Korea
Career : [email protected] · Homepage www.celltrion.com

11
Pharmaceutical

BINT Medicine R&D Corporation for Terminal Illnesses

(BINT: Bio-Info-Nano Technology)

Chong Kun Dang Pharmaceutical Corp.

Chong Kun Dang Pharmaceutical Corp. (CKD) was established with the
objective of supplying the best quality medicine to the people who need them
and performing its business activities for the development of pharmaceutical
industry in Korea for over 70 years since its inception in May 1941.

Products
In 1968, CKD obtained US FDA approval for Chloramphenicol, Chloramphenicol palmitate and sterile Chloramphenicol
sodium succinate. It was the first commemorative US FDA approval for raw materials in Korean pharmaceutical
industry. In addition, CKD has gained additional US FDA approvals for raw materials such as Oxytetracycline
hydrochloride, Tetracycline, Rifampicin, Demeclocycline and so on.
Since exporting antibiotics to Japan in 1969, CKD has acted as a pioneer of Korean pharmaceutical companies by
entering more than 40 overseas markets with the finished products such as Rifampicin, anti-tuberculosis drug.
Lipilou tab., anti-hyperlipidemic agent In R&D, CKD was the first company to establish a Research Institute in 1972 among Korean pharmaceutical
companies. Through continuous research, CKD had succeeded in the development of many specialty products
such as Cipol N® (ciclosporin) and TacroBell®(tacrolimus), immunosuppressive agents for organ transplantations.
Such successful developments brought CKD a variety of awards such as Korea Technology Mark and Technology
Research Institute Prize.
In 2008, CKD’s Lipilou®(atorvastatin), a treatment for high cholesterol was awarded as Korea Technology Gold Prize, and
its new formulation and process improvement of atorvastatin were evaluated as Korea’s 10 New Technologies.
Camtobell inj., anti-cancer agent

R&D Pipeline
CKD has been focusing on research and development of New Chemical Entities(NCE), Incrementally Modified
Drugs(IMDs) and Bio-pharmaceuticals.
In the field of NCEs, Camtobell® was launched in 2004, as the first CKD new drug developed by its own technology.
Based on this successful experience, Duvie® which is a thiazolidinedion derivative for type 2 diabetes has been
Duvie® Tab. Anti-Diabetic agent
approved by Ministry of Food and Drug Safety(MFDS) in 2013 and launched on February 1st of 2014.
CKD-732 (beloranib) developed by CKD has been licensed out to Zafgen. Currently, CKD-732 is under development
for treatment of severe obesity and its phase IIb clinical trial for treating obese subjects with Type 2 diabetes has
been in progress in the US and Australia. Furthermore, CKD-732 showed positive efficacy on Prader-Willi Syndrome
and has been designated as an orphan drug by FDA & EMA. It is under phase III clinical trial in the US.
CKD-516 (Vascular Disrupting Agent) and CKD-581 (Pan-HDAC inhibitor) are drug candidates for the treatment of
solid and hematological cancers and are undergoing Phase I clinical trials. In addition, CKD-519 is a CETP inhibitor,
which increases HDL cholesterol, being developed for dyslipidemia and is in phase I clinical trial.
In case of IMDs, CKD is focusing on the development of combination products and DDS for a new type of oral
antibiotics and nanoparticles with the skilled infrastructure.
As of Bio-pharmaceuticals, CKD-11101, anti-anemia agent, is a biosimilar of NESP® and it successfully completed
phase I clinical trial. Multicenter Phase III clinical trial has been recently conducted to compare the efficacy
and safety of the reference product. CKD-12201, prophylactic HPV vaccine for cervical cancer prevention, has
successfully completed phase I clinical trial.

CONTACT US
· Company Chong Kun Dang Pharmaceutical Corp.
Indy Baik, Director · President & CEO Young-Joo Kim
Global Business Team · Specialty R&D of new medicine and incrementally modified drug (IMD)
• Phone : +82-2-3149-7849 · Location 8, Chungjeong-ro, Seodaemun-gu, Seoul, Korea
• E-Mail : [email protected] · Homepage www.ckdpharm.com

12
 Pharmaceutical
Big leap to global pharmaceutical company
CJ HealthCare Corp.

Heal the World, Better Life

CJ HealthCare
CJ HealthCare started its business as Pharmaceuticals Business Unit at CJ CheilJedang Corporation from 1984.
In line with CJ's corporate vision, CJ HealthCare has been striving for making people healthier, happier and better
convenient with innovative and differentiated pharmaceutical products. As of 1st April, 2014, CJ HealthCare was
spun off from CJ CheilJedang Corporation and became a separate pharmaceutical corporate entity with purpose
of enhancement of expertise in pharmaceutical business to grow globally.
CJ HealthCare has become a representative Korean pharmaceutical company in promising therapeutic areas
such as oncology, cardiology, endocrinology and nephrology. CJ HealthCare is working hard to grow globally,
focusing on rapidly growing China and Southeast Asian markets as well as highly-regulated but attractive Japan
and EU markets. Through our newly established cGMP compliant plant in Osong, CJ HealthCare can secure global
standard manufacturing facilities and operation capabilities.
CJ HealthCare will make its best efforts to jump into a leading position among global pharmaceutical companies.
Products
Product Details
1. Epokine Inj. (rh-EPO) Epokine® was developed 1st in Korea and 3rd in the world. Epokine® is safe and effective in treating
anemia of hemodialysis patients with end-stage renal disease.
2. Leukokine Inj. (rh- G-CSF) Chemotherapy in advanced cancer patients and in acute Leukemia patients can cause the Neutropenia.
Leukokine® can help to support their natural defenses during strong chemotherapy.
3. Vancorin Inj. (Vancomycin) Vancorin® is the best choice for MRSA & MRSE.
4. Tapocin Inj. (Teicoplanin) Tapocin® has excellent antibacterial effects on MRSA, MRSE and Enterococcus.
5. Moveloxin I.V. solution bag As a fourth-generation synthetic fluoroquinolone antibacterial agent, Moveloxin® I.V. solution bag is
(Moxifloxacin) convenient to use for doctors and nurses in hospitals.
6. Cinezolid I.V. solution bag As the treatment of vancomycin-resistant Enterococcus faecium infections, Cinezolid® I.V. solution bag
(Linezolid) is convenient to use for doctors and nurses in hospitals.
7. Calmtop Inj. (Irinotecan) Calmtop® Inj. is an injectable drug used for the treatment of colorectal cancer
8. Pemta Inj. (Pemetrexed) PEMTA® Inj. is a chemotherapy RTU (ready-to-use) injectable drug for the treatment of pleural
esothelioma and non-small cell lung cancer.
9. CONDITION CONDITION® has launched in 1992 creating a new market of hangover relief drink in Korea.
(Hangover relief drink)
10. HongSamJin Gold HongSamJin Gold® is an outstanding energy drink produced with 6-yeared red ginseng.
(Red Ginseng drink)
11. HutGaeSoo HutGaeSoo® contains the goodness of Hovenia dulcis with its function of liver protection.
(Thirst –quenching tea drink)
Contact Information
CJ HealthCare, Korea(Headquarters) R&D Pipeline
CJ CheilJedang Center, 330, Dongho-ro,
Description
Jung-gu, Seoul 100-400, Korea 구분 Pipeline DS PC PI PII PIII NDA MKT Licensed
• Tel: +82-2-6740-2181 Molecule Target Indication Territory
• FAX: +82-2-6740-2491 NEPA UNDISCLOSED antiemetics Korea
• E-mail: [email protected] Gastric Acid-Related Korea
(Kwang Hee Hong, PhD, MBA) CJ-12420 UNDISCLOSED Disorders China
NCE taiwan
CJ Europe GmbH IBAT Inhibitor
UNDISCLOSED Gastric Acid-Related
Ober der Roeth 465824 Schwalbach, Disorders
JAK Inhibitor
UNDISCLOSED arthritis
Germany Phyto-pharma. CJ-20001 UNDISCLOSED Gastritis
• TEL: +49-6196-590128 Atrovastatin, Type 2 Diabetes/
• FAX: +49-6196-45418 CJ-30056 Metformin Hyperlipidemia (FDC)
• E-MAIL: [email protected] Pemetrexed Hypertension/
(Youngsun Lee) CJ-30041 Soln. Hyperlipidemia
IMD CJ-30059 Candesartan, Hypertension (FDC)
CJ Japan Corp. Amlodipine
8F, CJ Bldg, 2-7-4, Nishishinbashi, CJ-30060 Atrovastatin, Type 2 Diabetes/
Minato-ku, Tokyo, 105-0003, Japan Metformin Hyperlipidemia (FDC)
• TEL: +81-3-3519-3452 CJ-30061 Bisoprolol, Hypertension/
Atrovastatin Hyperlipidemia (FDC)
• FAX: +81-3-3580-1055 CJ-40001 Darbepoetin Anemia
• E-MAIL: [email protected] (Sungbin Cho) Hand-Foot-Mouth UNDISCLOSED Hand-Foot-Mouth
Biologicals Disease vaccine Disease
China branch office LUCENTIS UNDISCLOSED Retinopathy
北京市朝阳区酒仙桥路20号颐堤 Biosimilar
港一座12层 P.C 100016
• TEL: +86 -10 - 5639 – 6053
• E-MAIL: [email protected] (Sangjae Lee) · Company CJ HealthCare corporation
· CEO Dal won Kwak, Chul ha Kim
Vietnam branch office · Specialty ETC (CVs, Antibiotics, IV Solution, Oncology, Endocrinology, Nephrology&Urology,
S18, 22F, STC Bldg, 37 TonDuc Thang Business Gastro Intestinal, Musculo skeletal, Respiratory, Others) & Health functional products
st. Dist.1, HCMC, Vietnam
• TEL: 84-8-3911-0458 · Head Office CJ CheilJedang Center, 330, Dongho-ro, Jung-gu, Seoul 100-400, Korea
• E-MAIL: [email protected] (Minki Ku) · Homepage www.cjp.co.kr

13
Pharmaceutical

Clinical Stage Biotech Company with Robust Pipeline and Proven Track
Record in Discovery and Development of Novel Drugs
CrystalGenomics, Inc.

CrystalGenomics, Inc. is a clinical stage biopharmaceutical company that is

dedicated to the discovery and development of novel pharmaceuticals with
innovative platform technologies to address significant unmet medical needs
in the areas of infectious disease, oncology and inflammatory diseases. The
Company is headquartered in Korea and has a US subsidiary company in
California for the management of multi-national clinical studies, and it is
publicly traded on the KOSDAQ exchange.
CrystalGenomics is developing several drug candidates for various therapeutic areas in different development
stages. Its lead drug program is Acelex® (polmacoxib), a next generation NSAID for osteoarthritis. The NDA has
been recently approved by the MFDS (Korean FDA). The second clinical stage program is CG400549, a first-in-class
antibiotic for MRSA where its phase 2a skin infection study in the US was recently completed with a positive
outcome of 100% clinical cure rate. The third clinical stage program is CG200745, a molecular targeted anti-cancer
therapeutic for various types of cancers, which is in phase 1b/2 ready stage. In addition to the aforementioned
programs, CrystalGenomics has several other drug programs in preclinical and discovery stages.
Products
· Polmacoxib (Next Generation NSAID for Osteoarthritis)
DRUG TARGET: Dual Cyclooxygenase-2 and Carbonic Anhydrase Inhibitor
INDICATION: Osteoarthritis
STATUS: Approved
- Polmacoxib is a novel NSAID with unique mode of action being developed for the relief of signs and symptoms of
osteoarthritis. After successful completion of a Phase 2a Proof-of-Concept study in Europe with 248 patients, a Phase
2b active-controlled efficacy study in Korea against Celebrex, and a Phase 3 active-controlled pivotal study has been
completed. The Korean NDA has been approved by the MFDS (Korean FDA) over 9 clinical studies in various parts of
the world, and more than several hundred patients have been dosed on polmacoxib. Based on the cumulative clinical
data, polmacoxib is projected to have an excellent safety and efficacy profile.
· CG400549 (Potentially First-in-Class Fab I Inhibitor for MRSA)
DRUG TARGET: Fab I inhibitor (enoyl-[acyl-carrier-protein] (ACP) reductase)
INDICATION: ABSSSI, Osteomyelitis, Other serious infections associated with Staph aureus.
STATUS: Phase 2a completed
- CG400549 is a novel antibiotic candidate for MRSA and recently obtained human POC from the completed Phase
2a Study in the US. Both Phase 1 Single Ascending Dose and Phase 1 Multiple Ascending Dose studies have
been completed in the EU.
- CG400549 is a novel antibacterial drug candidate that inhibits enoyl-[acyl-carrier-protein] (ACP) reductase
(fabI), an essential enzyme in fatty acid synthesis. Since fatty acids are an ingredient of bacterial cell walls, its
synthesis is critical for the survival of bacteria.
- F rom the phase 2a POC study, 90.9% of evaluable subjects had early clinical response at the ECE visit (48 to 72 hours
after enrollment or Day 3~4) and 100% of evaluable subjects were clinically cured by the TOC visit (Day 21~28)
· CG200745 (Potentially Best-in-Class HDAC Inhibitor for Solid Tumors)
DRUG TARGET: HDAC inhibitor
INDICATION: Various Solid Tumors and Hematologic Cancers (Pancreatic Cancer, Hepatocellular Carcinoma, Colorectal
Cancer, MDS, etc.)
STATUS: Phase 1 completed, Phase 1b/2 being prepared for pancreatic cancer and MDS
- CG200745 is an anti-cancer agent that deactivates HDAC, an enzyme that catalyzes the histone deacetylation. CG200745
shows a better profile when compared to other compounds in the same class such as Zolinza® of Merck & Co. (approved),
based on a series of anti-cancer efficacy tests using various cancer cell lines and xenograft animal models.
- In addition to superb efficacy and safety demonstrated so far, CG200745 has shown excellent PK and PD profiles
and there is a good probability that it can be developed for a variety of solid tumor indications including pancreatic,
colorectal, and liver cancer.
R&D Pipeline
Area Candidate Indication NCE Type Ph I Ph IIa/IIb Ph III Registration
Inflammation Polmacoxib Osteoarthritis FIC1
Infectious Disease CG400549 ABSSSI, MRSA FIC, BIC2
Oncology CG200745 Various solid & liquid tumors BIC2
1 First-in-Class; 2 Best-in-Class

CONTACT US · Company CrystalGenomics, Inc.

· CEO Joong Myung Cho, Ph.D.
Steven Kim, R.Ph., MBA, · Specialty Business Discovery and Development of Novel Therapeutics
Director, Business Development · Head Office 5th F., A Tower, Korea Bio Park, 700 Daewangpangyo-ro, Bundang-gu,
• Phone : +82-31-628-2720 Seongnam-si Gyeonggi-do, 463-400 Korea
• E-mail : [email protected] · Homepage www.crystalgenomics.com

14
 Pharmaceutical
Respecting Life & Serving Society
Dae Hwa Pharmaceutical Co. Ltd.

DAE HWA has developed all kinds of medicines ranging from peptic ulcer
medicines to preventive and assistant treatments including a cancer, adult
related disease, etc.
DAE HWA was established in 1984 with the vision of pursuing the happiness of mankind. With the completion
of the cGMP facilities in 2009, we are striving to produce high quality medicines.
Currently, we are producing 150 kinds of medicine and supplying to around 3,000 hospitals nationally as well
as conducting business with around 6,000 pharmacies.
Kebanon plaster
Our lipids-based oral formulation technology is an outstanding global leading technology. DHP107, an oral
paclitaxel formula, is mainly composed of edible oils and does not need co-administration of an absorption
enhancer or efflux pump inhibitor.
Ongoing phase 3 clinical trial will be completed soon and DAE HWA is expecting first approval of oral
Loxona Cataplasma paclitaxel form in the world. Also, we have plan for worldwide clinical development and commercialization
with a collaboration or partnership.
DAE HWA is continuing our research on transdermal drug delivery system (TDDS) technology. Moreover, we
are developing a new platform technology for Orally Disintegration Film (ODF) products. Also, DAE HWA
is focusing on the developing of innovative herbal products both as medicines and functional foods for
Resnalin patch cardiovascular, neurological area.
As well as the release of Kebanon, Loxona, Plocfen, Hyemingo, DDL (NSAIDs medication), Resnalin (asthma
medications, 2010), Duphenyl (narcotic analgesics, 2014) and Rivamensa (dementia medication, 2014), we
are understudying to release reformulated NSAIDs, incontinence medicines, antihistamine medications,
antidepressants, antivirus medicine, CSN medication etc. using TDDS/ODF technology and developing new
DDL Plaster herbal medicine & functional food for Alzheimer’s and Parkinson’s disease.

Global Business
DAE HWA has been exporting to Asia, South America, Africa and Middle East. And at now, DAE HWA has
Rivamensa Patch
trading relationship with 22 countries in the world.

For the newly developed European market, DAE HWA launched anti-inflammatory analgesic plaster and
cataplasma from France and Bulgaria as center. And for the US market which started exporting since end of
2012, and DAE HWA will gradually increase exporting products in the US market through the continued R&D,
Top-Roll soft cap. market research and localization.

And in case of China which also has huge market, DAE HWA already entered into supplying and distribution
CONTACT US agreement for 4 products.

Overseas Business
• Hanwonng, Seo
Tel: 82-2-6716-1071
e-mail: [email protected]
• Paul, Cho
Tel: 82-2-6716-1072
e-mail: [email protected]
· Company Dae Hwa Pharmaceutical Co. Ltd.
Regulatory Affair · CEO Han Koo, Lee & Soo Ji, Kim
• Claire, Kim · Specialty Medicinal Products
Tel: 82-2-6716-1073 · Location (Seoul Office) 2038 DaeHwa Bldg., Nambusunhwan-ro, Gwanak-gu, Seoul, Korea
e-mail: [email protected] · Homepage www.dhpharm.co.kr

15
Pharmaceutical

Reliable Partner for Human Health

Daewon Pharmaceutical Co., Ltd.

Be a partner who protects healthy life of human beings based on reliability and
trust of customers.
Since the establishment in 1958 with a founding idea of “realization of human health.”, Daewon Pharm. Co., Ltd.
Has made the best efforts for human health and happiness through manufacturing and providing specialized
medicines. We produce reliable and safe medicines by securing world-class manufacturing facilities and
superior R&D capabilities.

Daewon pharm produces both vitamins to improve human health and other specialized medicine for circulatory,
respiratory, antibiotic, chemotherapy and psychoneurosis uses. You can find information about our products on
our homepage(www.daewonpharm.com). Please visit our website for the details.

With its first export to Vietnam in 1994, Daewon Pharm has made eye-opening achievements of exports. Now,
We export our products to 40 countries such as China, Latin America, Middle East, CIS, and Africa. Daewon
is exporting about 50 products and is expanding its export volume with products such as Pelubi tablet, a new
chemical entity, and Oramin Capsule, multivitamin supplement with Korean Ginseng.

Products
Oramin Capsule
World’s favorite multivitamin, Oramin Cap., by Daewon contains high quality Korean Ginseng and royal jelly as
well as all sorts of vitamin and minerals necessary for vital daily life. Oramin, Our representative global brand,
demonstrates the superiority of Korean ginseng all over the world, being ranked first out of multivitamin brands
in 4 countries.
Oramin Capsule
Pelubi tablet(the 12th new medicine in Korea)
The Pelubi tablet, a series of NSAIDs, was developed in the whole process from raw materials to end product only
by Daewon Pharm and Certificated as the 12th new medicine by Korean Food and Drug Administration. It is a highly
effective NSAIDs for pain relief which has less side effects than existing NSAIDs products.

Pelubi tablet R&D Pipeline

Tech. Type Project Indication Stage
NCE DW10558 Hypercholesterolemia Pre-clinical
NCE + Sustained Release DW0908 NSAIDs Application submitted
Natural Extract +
DW1401 Gastritis Phase Ⅲ
Sustained Release
DW1030 Antispasmodic Application submitted
Sustained release
DW8486 Epilepsy Phase Ⅰ
DW340 NSAID + Antispasmodic Phase Ⅰ
CONTACT US Combination
DW0929 Hypercholesterolemia Phase Ⅲ
Andy Lee
• Phone : +82-2-2204-6971
• E-mail : [email protected] · Company Daewon Pharmaceutical Co., Ltd.
· CEO Baek, Seung Ho / Baek, Seung Ryel
SinHo Choi · Specialty Drug manufacture and sales
• Phone : +82-2-2204-6975 · Location 229-3 Yongdap Dong, Sungdong-Gu, Seoul, Korea
• E-mail : [email protected] · Homepage www.daewonpharm.com

16
 Pharmaceutical
Pharmaceutical Company with the No.1
Sales of Prescription Drugs in Korea
Daewoong Pharmaceutical Co., Ltd.

Daewoong Pharmaceutical is the pharmaceutical company with the No. 1

sales of prescription drugs in the Korean market.
Established in 1945 in Seoul, South Korea, Daewoong Pharmaceutical offers high-quality and innovative pharmaceutical
products and is one of the top market leaders in Korea.
For over 60 years, Daewoong Pharmaceutical has been providing better health for people through its total dedication to
healthcare. Daewoong has built strong core competency for new drug development to meet diverse medical needs and
enhance human life.
Building on our core strength, Daewoong Pharmaceutical has involved in becoming a global healthcare group by
operating our foreign branches in SE Asia and by collaborating with global partners. We have an inspiring mission to
become a top 50 global healthcare company which contributes to improving the quality of life for people worldwide.

The reinforcement of the R&D capacities through the establishment of R&D center in the USA, China and India.
Daewoong Lifescience Research Institute has been focused on developing new chemical entities, biologics,
incrementally modified drugs and high-value added APIs. Daewoong has also been studying to find solutions
for the unmet therapeutic needs of neuropathic pain disease, Alzheimer’s disease as well as other innovative
programs like anticancer gene therapy. Daewoong is operating several overseas offices in China, Vietnam,
Indonesia, Thailand, Philippines, USA, and India and has R&D centers in China, India and America.

R&D Pipeline
New Chemical Entities
Development Status
Code type indication
R Pre PI PII PIII M
DWJ205 Fungicidal Oral fungicidal program ○
DW206 APA (Acid Pump Antagonist) Antiulcer program ○
DWJ208 Ion channel blocker Neuropathic pain, Cancer pain ○
DW209 PRS inhibitor Lung cancer, pancreatic cancer ○

Biologics
Development Status
Brand MOA Description
R Pre PI PII PIII M
Dental sinus lifting graft ○
Novosis BMP-2
Spinal fusion device ○
Diabetic foot ulcer, spray type ○
Easyef EGF Oral mucositis, spray type ○
Acute wound healing (OTC) ○
Lyophilized powder ○
Caretropin hGH
Pen type injector + Liquid Cartridge ○
Eposis EPO Biosimilar, Recombinant Human Erythropoietin ○
Glabellar lines ○
Nabota Botulinum toxin type A
Upper Limb Spasticity ○

Value-added Generics & Generics

Development Status
Brand MOA Description
CONTACT US R Pre PI PII PIII M
Olostar Olmesartan + Rosuvastatin fixed dose combination ○
Early Stage Collaboration and URSA Ursodeoxycholic acid 250/300/500mg Tablets ○
License In/Out Albis Ranitidine + Bismuth + Sucralfate fixed dose combination ○
• Ms. Alice Lee, Manager Dihecta Dioctahedral smectite suspension ○
Luphere Leuprolide PLGA polymer encapsulated depot ○
Connect & Development
Neovest Iopromide X-ray contrast agent ○
• Phone : + 82-31-270-8328 Nurigra Sildenafil tablet ○
• E-Mail : [email protected] Nurigra Chew Sildenafil chewable tablet formulation ○
Imatinib Imatinib Generic of Glibec (100mg: BE, 400mg P1) ○
Global Business Development and
License Out
· Company Daewoong Pharmaceutical Co., Ltd.
• Mr. Doyoung (Brian) Kim, Senior · CEO Lee, Jong Wook
Manager, Global Strategy Dept. · Specialty small-molecule new drugs, biological drugs, value-added chemical drugs
• Phone : +82-2-550-8936 · Head Office 163-3, Samsung-dong, Kangnam-gu, Seoul, Korea
• E-Mail : [email protected] · Homepage www.daewoong.com

17
Pharmaceutical

Human & Life

Dongkook Pharmaceutical

Dongkook Pharmaceutical is marching into the world with global

competitiveness.
For the past 44 years, Dongkook Pharmaceutical has made continuous efforts to uphold respect for life and healthy
national lives on the basis of corporate philosophy of creativity, harmony and credibility.
Since the company was listed on the KOSDAQ in May 2007, Dongkook Pharmaceutical’s strong R&D capabilities
and corporate values have been widely recognized. Today, Dongkook Pharmaceutical is being reborn as a global
enterprise that has proven its potential power to the whole world.
Dongkook Pharmaceutical has also been well recognized in and outside Korea with the superiority of the products
and the competitive product portfolio in the field of prescription medicines. Dongkook Pharmaceutical has
developed and produced outstanding therapeutic products through various clinical trials.
In 2006, Plant 2 acquired a rating of Grade A, the highest grade, in the injection sector from the GMP (Good
Manufacturing Practice) assessment rating system. Plant 3 followed suit in 2008, receiving a Grade A rating during
the assessment rating conducted by the government; thus proving high-level GMP management. For the first time
in Korea, Dongkook Pharmaceutical met the European GMP standard in the injection sector; even in the API sector,
Dongkook Pharmaceutical owns products complying with the EU Guidelines of EDQM (European Directorate for
the Quality of Medicines).
Currently, Dongkook Pharmaceutical exports finished product and API to over 50 countries, especially on EU, Japan
and other advanced countries with the strict regulations for pharmaceuticals. It seeks to grow into a global leading
pharmaceutical company that is trusted and loved by all domestic and overseas customers backed by the greatest
global competitiveness.
No. The name of Product Main Ingredient Use(Indications)
1 PAMIRAY INJECTION Iopamidol X-ray contrast media for neuroradiology
Induction and maintenance of General
2 POFOL INJECTION Propofol 10mg per 1ml
anaesthesia
3 TEICOPLANIN INJECTION Teicoplanin Skin and soft tissue infections
4 DURAKINASE INJECTION Streptokinase Acute myocardial infarction
5 LORELIN DEPOT INJECTION Leuprorelin acetate Prostatic Cancer

R&D Pipeline
In 1990, Dongkook Pharmaceutical focused on developing products through selection and concentration in
specialized fields, succeeding in the development of Minocline Strip (Local Drug Delivery System), the periodontitis
medicine and the manufacture of Pofol (Propofol preparation), the intravenous general anesthetic.

These two technologies were recognized as Excellent Korean Technology (KT) by the Ministry of Science and
Technology in 1995 and 1996 respectively. In 2005, the company was again lauded for the superiority in formulation
technologies related to long-term sustained release of peptide medicine, and it was designated as Advanced
Technology Center (ATC) by the Ministry of Knowledge Economy.
Currently, the Central Research Institute’s efforts are focused on developing new products requiring creative and
multidisciplinary knowledge foundation, utilizing the platform technologies of synthesis, fermentation, hydrogel,
nano-emulsion, microsphere based long-acting release, and multi-particles. The development of such innovative
product groups serves as a footing for expanding business areas to prescription medicine markets from over-the-
counter (OTC) medicine markets and to overseas markets from domestic markets.

CONTACT US · Company Dongkook Pharmaceutical

· CEO Lee, Young Wook; Oh, Hung joo
• Phone : + 82-2-2191-9859 · Specialty Pharmaceutical
• Fax : +82-6234-0589 · Location 997-8, Daechi-2dong, Gangnam-gu, Seoul, Korea
• E-Mail : [email protected] · Homepage http://www.dkpharm.co.kr/english

18
 Pharmaceutical
GemVax & KAEL Co., Ltd. is an innovative company dedicated to development,
commercialization of anti-cancer vaccine, peptide vaccine and infectious disease DNA vaccine.
GemVax & KAEL Co., Ltd.

GemVax & KAEL Co., Ltd. is an innovative company dedicated to

development, commercialization of anti-cancer vaccine, peptide vaccine
and infectious disease DNA vaccine.

Products
RIAVAX® (code name: GV1001) is the “first-in-class” therapeutic vaccine for the treatment of patients with
pancreatic cancer. In September 15, 2014 Korean Ministry of Food and Drug Safety (MFDS) granted RIAVAX®
a marketing and manufacturing authorization in Korea as a treatment of locally advanced or metastatic
pancreatic cancer patients whose serum level is higher than 81.02pg/mL in combination with Gemcitabine/
Capecitabine.
RIAVAX® is a peptide vaccine derived from human telomerase that is abundantly expressed in most of
human cancers. Briefly, the mechanism by which RIAVAX® kills cancer cells is to elicit combined CD4+/
CD8+ T cell responses, thereby inducing tumor eradication as well as long term memory. The safety and
RIAVAX efficacy/Immunogenicity of RIAVAX® in pancreatic cancer has been investigated and confirmed in number
of previous thirteen clinical trials. In a large-scale phase lll trial TeloVac, the safety and immune-modulating
effect of RIAVAX® were confirmed in over 1,000 patients. The key finding obtained from the TeloVac trial
was that RIAVAX® markedly prolonged the survival in a group of patients having high serum eotaxin level
(>81.02pg/mL).

R&D Pipeline
Description Indication Status
Prostate Cancer Ph lll
Cancer therapeutic vaccine
NSCLC(Non-Small Cell Lung Cancer) Ph llI
BPH(Benign Prostate Hyperplasia) Ph ll
Peptide Drug
Alzheimer’s Disease Non-clinical
HIV(Human Immunodeficiency Virus) Ph l/ll
HPV(Human Papilloma Virus) Non-clinical
Infectious Disease DNA Vaccine Malaria Ph l
Influenza Non-clinical
HBV(Hepatitis B Virus) Non-clinical
PADRE (Pan-DR Epitope) -
Vaccine Development Technologies
EIS (Epitope Identification System) -

CONTACT US
Jiyeon Yoo, Deputy General Manager, · Company GemVax & KAEL Co., Ltd.
Strategy & Planning · CEO Sang Jae Kim, Kyung Hee Kim
• Phone: +82-2-544-6221 · Specialty Developing, Manufacturing, Commercializing Biological Therapeutics
• Fax: +82-2-3443-4997 · Head Office 146 Unjung-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea
• E-mail : [email protected] · Homepage www.gemvax.com

19
Pharmaceutical

To Improve Patient’s Quality of Life

Genexine, Inc.

Genexine, Inc. (KOSDAQ, 095700) is a leading biotechnology company specializing in immunotherapeutics,

based on its strong immunology expertise and R&D capabilities. Founded in 1999, Genexine consists of about
hundred employees, half of which are scientists with MSc or PhD. Genexine is located in Korea Bio Park, Pangyo
Techno Valley near Seoul, Korea.

Platform Technology
1) hyFc technology – next generation half-life extension technology: Genexine creatively invented hybrid Fc
fusion half-life extension technology that enables long-acting protein therapeutics with well-balanced benefit of
efficacy, safety, convenience, cost-efficiency as well as substantially low risk of immunogenicity.
2) therapeutic DNA vaccine technology for infectious diseases and cancer: Through long history of DNA
vaccine R&D, Genexine has accumulated extensive technology and know-how of therapeutic DNA vaccines
against viruses such as HPV, HBV, TB, etc. DNA vaccine induces robust antigen-specific immune response against
infected cells or cancer.
Based on proprietary innovative platform technology, Genexine has developed various products in preclinical and
clinical-stages. Genexine’s major clinical pipelines are GX-H9 (long-acting hGH-hyFc) in Phase II in EU and Korea and
GX-188E (therapeutic HPV DNA vaccine) in Phase II in EU and Korea. In pre-clinical stage, Genexine has GX-P2 (PD-L1-
hyFc as a PD-1 agonist) for autoimmune diseases, GX-I7 (IL-7-hyFc), GX-F7 (long-acting Factor VII-hyFc), etc.

Major Pipelines
1) GX-H9 (Long-acting hGH-hyFc): Long-acting human growth hormone (hGH) genetically fused with Genexine’s
proprietary hybrid Fc (hyFc) platform. The first in human trial has been completed in EU and currently a multinational
AGHD patient phase 2 clinical study is being conducted in EU and Korea. In phase I clinical trial, no SAEs and
ADA formation were reported, and dose-dependent PK and PD (IGF-1 level) profiles were demonstrated. GX-H9 is
targeting pediatric and adult growth hormone deficiency patients with weekly and semi-monthly administration
and being co-developed with Handok Pharmaceuticals.
2) GX-188E (HPV therapeutic DNA vaccine): HPV therapeutic DNA vaccine for Cervical Intraepithelial Neoplasia
(CIN) / Cervical Dysplasia in Phase II clinical trial. GX-188E has the potential to induce complete regression from
high grade Cervical Intraepithelial Neoplasia caused by high-risk types of HPV16/18 infection. In Phase I clinical
trial, Genexine demonstrated that electroporation(Ichor Medical Systems)-enhanced immunization with a rationally
designed HPV DNA vaccine (GX-188E), preferentially targeting HPV antigens to dendritic cells, elicits a significant
E6/E7-specific IFN-γ-producing T-cell response in all nine cervical intraepithelial neoplasia 3 (CIN3) patients. Seven
out of nine patients displayed complete regression of their CIN3 lesions and viral clearance and exhibited an
enhanced polyfunctional antigen-specific CD8 T-cell response within 36 weeks of follow up. These results were
recently published in Nature Communications (Kim et al., Nature Comm., 2014; 5,5317).
3) GX-P2 (PD-L1-hyFc as a PD-1 agonist): GX-P2 is PD-L1-hyFc as a PD-1 agonist, which is a first-in-class drug
candidate in preclinical stage for autoimmune diseases. It is based on our innovative long-acting hyFc technology
(next generation Fc fusion technology). GX-P2 is designed to induce T-cell tolerance by targeting PD-1 and/or B7.1 and
able to regulate uncontrolled T-cell activation or proliferation in autoimmune diseases. We confirmed animal PoC in
inflammatory bowel disease (IBD) and published the results in Gut journal (Song et al., Gut, 2015; 64(2):260-271).

R&D Pipeline
Collaboration Discovery Pre- Clinical
Technology Product Indication Concept Partners Clinical I II III
DNA Vaccine GX-188E Cervical pre-cancer Ichor Medical
HPV DNA vaccine
Technology therapeutic DNA vaccine Systems
Growth hormone
GX-H9 Long acting hGH Handok
deficiency therapeutic
GX-E2 Anemia Long acting EPO Green Cross
hyFc GX-G3 Neutropenia Long acting G-CSF ILKOGEN
Technology GX-P2 Autoimmune Diseases PD-L1(PD-1 agonist) -
GX-F7 Hemophilia Long acting Factor XII Handok
CONTACT US GX-I7 Infectious Diseases Long acting IL-7 -
GX-G6 Type 2 Diabetes Long acting GLP-1 -
Business Development
Jaehan Park
· Company Genexine, Inc.
General Manager/Head of Business · CEO Young Chul Sung, Ph.D
Development Office 1 · Specialty Hybrid Fc fusion (hyFc) proteins, DNA therapeutic vaccine
• Phone: +82-31-628-3260 · Location 700 Daewangpangyo-ro, Korea Bio Park Bldg. B, Bundang-gu, Seongnam-si, Gyeonggi-do 463-400, Republic of Korea
• E-mail : [email protected] · Homepage http://genexine.com

20
 Pharmaceutical
Development of Medications That Are Difficult to
Produce but Necessary
Green Cross Corp.

Green Cross is an exemplary R&D-oriented company that leads the

biotechnology industry in Korea. This is clear given what Green Cross has
achieved since its foundation in 1967.
GCC has pioneered in the field of biopharmaceuticals, such as vaccines, plasma-derivatives, diagnostics, recombinant
proteins and therapeutic antibodies. GCC has been well known for the R&D and commercialization of ‘HepavaxTM B’,
a world’s biggest selling hepatitis B vaccine, ‘HantavaxTM’, a world’s first epidemic hemorrhagic fever vaccine, and
‘SuduvaxTM’, a world’s second chicken pox vaccine. A complete flu pipeline includes seasonal flu vaccine (GCFLUTM),
H1N1 vaccine, avian flu vaccine and etc. GCC is also pursuing opportunities in rare diseases developing therapies for
Hunter syndrome (HunteraseTM) and Fabry disease (GC1119). With continuous investment in R&D, its portfolio now
includes gene/cell therapeutics and small molecule drugs. In 2011, GCC earned $616 million in revenue recording it
as 3rd largest Korean pharmaceutical company and invested $51.7 million in R&D which is one of the highest in Korea.

Products
Plasma Fractions & Recombinants
Starting from the nation’s first Albumin production in 1971, Green Cross currently manufactures more than 12
plasma fractions including immunoglobulin, anti-hemophilic factors, and anti-thrombin factor. Recent innovations
include ‘BDD rhFVIII (GreenGeneTM F)’, a 3rd Generation of recombinant Factor VIII for hemophilia A treatment.

Vaccines
We succeeded to develop the world’s third Hepatitis B vaccine in 1983, the world’s first epidemic hemorrhagic
fever vaccine in 1988. With the construction of Hwasun plant, a vaccine-oriented manufacturing facility, the
influenza vaccine GC FluTM became the fourth in the world to obtain PQ (Pre-Qualification) approval from the WHO.

ETC& OTC Medicines

Green Cross has provided a broad range of ethical medicines in the field of cardiovascular disease, cerebrovascular
disease, metabolic disease including diabetes, hypertensive disease. Along with poultices (one of our core OTC
products), we also have provided OTC products in respiratory, dermatology and immunology.

R&D Pipeline
Project Indication R NC IND Ph I Ph II Ph III NDA A M
GCFLU™ Seasonal flu
GC1109 Anthrax
GC1107 Tetanus, diphteria
GC3104A D.T.P prophylaxis
GC3106A Seasonal flu(Cell culture)
GreenGene™ F Hemophilia A US
CONTACT US Hunterase™ Hunter syndrome
Sung-Ick Park IVIG-SN Infections US
General manager GCPGC Neutropenia
Business Development Division GC1113 Anemia
• Phone : +82-31-260-9358 GC1119 Fabry Disease Protein
• Fax : +82-31-260-9408 GC2107 Anti-thrombotics US
• E-Mail : [email protected]
MG4101 Cancer Cell therapy
Hong-kwon Woo, Manager,
Global Business Team · Company Green Cross Corp.
Overseas Business · CEO Il-Sup, Huh
• Phone : +82-31-260-9415 · Specialty Plasma Derivatives & Recombinant Proteins, Vaccines, ETC& OTC Products
• Fax : +82-31-260-9491 · Location 303 Bojeong-dong, Giheung-gu, Yongin, Korea
• E-Mail : [email protected] · Homepage www.greencross.com

21
Pharmaceutical

Innovative Medicines to Improve the Quality of

Human Life
HanAll BioPharma Co. Ltd.

HanAll BioPharma is a R&D-oriented pharmaceutical company, currently

listed on the Korean Stock Exchange (KOSPI).

R&D Pipeline
Product Information
HL156Can, a mitochondrial primer, is a New Chemical Entity (NCE) targeting cancer metabolism, inhibiting
mitochondrial OXPHOS system. This inhibition leads to ATP depletion, which increases metabolic stress
in cancer cells. HL156Can exhibits cytotoxic effect in cancer cells with defected AMPK signaling function
and cytostatic effect in cancer cells with normal AMPK signaling function. HanAll has confirmed potential
HL156CAN efficacy of HL156Can to overcome resistance in number of selected cell lines. Currently, HanAll is
conducting in-vivo experiments with LKB1 -/- (NSCLC) xenograft model, Braf V600E inhibitor resistant
melanoma xenograft model, and lapatinib resistant xenograft model.
*Preclinical Stage (Aug. 2013)

HL036 is TNF-alpha receptor fragment for the treatment of local inflammatory diseases caused by TNF-
alpha such as uveitis, dry eyes, and AMD. Current systemic anti-TNF drugs’ limitations include small
volume of distribution and adverse drug events due to high dosage. Therefore, by utilizing fragment,
HanAll’s TNF receptor fragment will have greater volume of distribution when administered topically
compared to currently marketed anti-TNF-alpha products having larger molecular size. Furthermore, via
HL036 protein engineering, HL036 will have greater affinity to allow smaller doses and increase the efficacy.
It is anticipated that higher concentrations of HL036 will be found in targeted ocular areas when
administered topically, preventing systemic ADEs. HanAll aims to utilize this unique property of HL036
for the indication of dry eyes by developing ophthalmic solution.
*Preclinical Stage (Aug. 2013)

HanAll is currently developing fully human monoclonal antibodies targeting the Fc Neonatal Receptor
(FcRn) for the treatment of autoimmune diseases caused by IgG autoantibodies.
FcRn plays an essential role in IgG homeostasis by regulating a salvage pathway that prevents lysosomal
degradation of IgG, thus contributing to a long half-life in the circulation. While FcRn-mediated half-life
HL161 extension is beneficial for IgG antibody responses against pathogens, it also prolongs the serum half-life
of IgG autoantibodies and thus promotes tissue damage in autoimmune diseases.
Hence, HL161 will reduce overall concentration of IgG by blocking FcRn, leading to reduced levels of
pathogenic IgG.
*Preclinical Stage (Aug. 2013)

HL009, adenosylcobalamin liposomal gel, has three different potential mechanisms of actions for the
treatment of atopic dermatitis. HL009 can bind to nitric oxide (NO) which causes dermatitis; also it
can inhibit inducible nitric oxide synthase (iNOS) to further reduce NO levels. From an immunology
perspective, HL009 can activate T regulatory cells which excrete IL-10 and TGF-beta suppressing
immune response.
HL009 Adenosylcobalamin has low permeability through skin due to its large molecular size and relatively
high hydrophilicity. Thus, HanAll has formulated adenosylcobalamin topical product utilizing liposomal
formulation technology. Benefits of liposomal formulation technology include improved stability,
enhanced skin penetration due to increased lipophilicity, and reduced skin irritation by using lipids with
proven safety.
CONTACT US *KR Phase II (complete) / US Phase II (complete) (Aug. 2013)
Soonim Lee, Director HL040, a fixed dose combination product, is composed of atorvastatin and losartan for the treatment of
• Phone : +82-2-2204-1753 hyperlipidemia and hypertension. HanAll finished the phase I study, and currently conducting phase III
• E-mail : [email protected] HL040 trial in Korea and phase I study in US.
*KR Phase III (In-progress) / US Phase I (complete) (Aug. 2013)
US BRANCH
S. T. Oh, Director
• Phone : +1-301-738-3980 · Company HanAll BioPharma Co. Ltd.
· CEO Dr. Sungwuk Kim
• E-mail : [email protected] Dr. Seungkook Park
HPI. Inc. · Specialty 1) Oncology & Fibrotic Disease 2) Infectious Diseases 3) Immunology 4) Endocrinology
9605 Medical Center Drive, Suite #290 · Location 11-10 Sincheon-dong, Songpa-gu, Seoul, Korea
Rockville, MD, 20850 · Homepage www.hanallbiopharma.com

22
 Pharmaceutical
The Health Innovator
HANDOK Inc.

HANDOK (Chairman & CEO Young-Jin Kim), a leading innovation-driven

pharmaceutical/health-care company in Korea, develops, manufactures and
distributes healthcare solutions to improve the health and quality of human life.
Handok has a core business focus in diabetes, cardiovascular, muscular skeletal, psychoneurotic disease,
human vaccines, medical devices, diagnostics and consumer health. Handok, founded in 1954, grew as a joint
venture with Hoechst/Aventis/Sanofi from 1964 to 2012. Handok has also established strategic collaborations
in several areas with multiple multinational pharmaceutical companies. For more information, please visit
www.handok.co.kr.

Main Products
Amaryl M(Glimepiride + Metformin HCl)
- The first fixed dose combination of glimepiride and metformin HCl in Korea.
- provides glycemic control with favorable safety profile.
- registered in 90 countries and exported to 14 countries.
Amaryl M
Amaryl Mex(Glimepiride + Metformin HCl)
- The first patented sustained-release fixed dose combination of glimepiride and metformin HCl. (Winner of
Korea New Drug Award, 2009)
- applied by DRM technology (Dual Release Micro-coating Technology).
- registered by 74 countries and exported to 6 countries.
Ketotop Plaster (Ketoprofen)
- No. 1 plaster for arthritis and muscular pain in Korea
Amaryl Mex
- Patent in 15 countries and Launched in 4 countries

R&D Pipeline Small molecules

Biologics

Project Indication Discovery Pre-clinical Phase I Phase II Phase III

HL5171 Cancer
Ketotop Plaster
HL5201 Diabetes/Metabolism
HL3715 Diabetes
HL3501 Glaucoma
HL5945 Alopecia
HL2351 Auto-inflammatory disorders
HL2356 Growth Hormone Deficiency Collaboration with Genexine
HL2353 Hemophilia
HL1513 Diabetes Launch in 2015

CONTACT US · Company HANDOK Inc.

· CEO Kim YoungJin
SoHyun Kwon · Specialty Pharmaceutical product(ETC, OTC), Medical devices
HeadofLicensing&BusinessDevelopment · Location 132, Teheran street, Gangnamgu, SEOUL, 135-923
• E-mail : [email protected] · Homepage www.handok.co.kr

23
Pharmaceutical

Thinking of the Human Health and the Future

HANLIM PHARM. CO., LTD.

With the corporate mission of protecting the precious human life from various
forms of diseases, HANLIM has consistently endeavored to improve the
health standards of people, and we have grown to become one of the leading
companies in Korea.
In 1993, the future-oriented GMP factory was completed together with the founding of the central research
center. As a part of the long-term investment scheme of the company, we continue to make a great investment
in accumulating advanced technologies and reorganizing manufacturing facilities lately to enhance the health of
mankind as a leading pharmaceutical company.

POSOD
EYE DROPS
Products
[1] POSOD EYE DROPS : Anti-cataract (Potassium iodide 3mg, sodium iodide 3mg)
- Treatment of opacity and hemorrhage of vitreous body caused by aging, myopia, hypertension, diabetes,
periphlebitis and lens opacity as early symptom of senile cataract.
[2] NASAFLEX NASAL SPRAY : Anti-allergic rhinitis agent (Mometasone furoate 0.5mg, Azelastine HCl 1.4
mg)
NASAFLEX
- Perennial allergic rhinitis
NASAL SPRAY
[3] RISENEX PLUS TAB : A  nti-osteoporosis agent including Vitamin D (Sodium Risedronate 35mg,
Cholecalciferol 5,600IU)
- Treatment and prevention of postmenopausal osteoporosis
- Treatment of osteoporosis in men

RISENEXPLUS TAB [4] DAGES CAP. : D  igestives (Pepsin 25mg, Papain 50mg, Diastase 15mg, Cellulase 15mg, Pancreatin 50mg,
Pancrelipase 13mg, UDCA 25mg)
- Insufficiency of gastric, enteric and pancreatic secretion
- Anorexia, meteorism, flatulence, steatorrhea, fermentative, dyspepsia with intestinal irregularity
- Dyspepsia in cholecystectomized patient
DAGES CAP - Superalimentation during convalescence and fattening diets
- Insufficiency of biliary secretion
- Cholelithiasis, cholecystitis, cholangitis, jaundice

R&D Pipeline
Category Products Indication Development stage
HL-CER osteoarthritis phase I
Incrementally modified HL-SAS hypertension phase I
drugs HL-PIF hyperlipidemia phase III
Entelon osteoarthritis phase III
HL-217 AMD phase I
New drugs
HL301 acute/chronic bronchitis phase III

Contact Information
· Company HANLIM PHARM. CO., LTD.
SUNG DAE, KIM · CEO JAE YOON, KIM
(Manager / Overseas trade) · Specialty Business R&D and manufacturing of API/BPIs, pharmaceutical product
• Phone : (822) 3489-6127 · Location 42, 52 Gil, Seochodaero, Seocho-Gu, Seoul, Korea
• E-Mail : [email protected] · Homepage http://www.hanlim.com

24
 Pharmaceutical
R&D Driven Pioneer for Innovation in Life Sciences
Hanmi Pharmaceutical. Co., Ltd.

Established in 1973, Hanmi Pharmaceutical now is the No.1 R&D

focused pharmaceutical company in Korea with highest R&D investment
for many years.
Hanmi Pharm. Co., Ltd. is a Korea-based global pharmaceutical company focused on the development and
commercialization of new pharmaceutical products. The Company is fully integrated from R&D through
manufacturing, marketing and sales with an established presence in Korea as well as China. The Company
invests over 16% of its sales in R&D and has over 20 programs in clinical development in three main areas: 1)
novel long-acting biologics based on the Company’s LAPSCOVERY™ platform that aim to shift treatment paradigm
of diabetes and obesity with weekly insulin, weekly to monthly GLP-1, and their combinations (Quantum Project);
2) novel targeted agents against cancer and autoimmune disorders; and 3) fixed-dose combination programs.
The Company has collaboration with global partners on various co-development and business opportunities.

R&D Pipeline
Focus on Metabolic & Cancer area for New Biologics
Clinical
Category Candidates Characteristics Research Pre-
I II III
Esomezol Cap. clinical
- Long-acting CA-Exendin-4 analog
HM11260C
- Once a week ~ month administration; US, EU, KR
(LAPSCA-Exendin-4)
T2DM / Obesity
HM12470 - Long-acting Insulin analog
Diabetes / US
( Insulin115)
LAPS
- Once a week administration; T1DM/T2DM
Obesity
Combination - Long-acting Insulin/Exendin-4 Combination
Amosartan Tab
( Insulin/ Exd-4) - Once a week administration; T2DM
LAPS LAPS

HM12525A - Long-acting GLP/GCG

(LAPSGLP/GCG) - Once a week administration; Obesity / T2DM EU
Endocrine HM10560A - Long-acting rhGH
Disease ( rhGH)
LAPS
- Once a week administration; Growth disorder EU
HM10460A - Long-acting GCSF analog
Oncology ( GCSF)
LAPS
- Every three weeks administration; US, EU
CONTACT US (Licensed-Out) Neutropenia

Licensing out Focus on oncology & autoimmune area for NCEs

Joshua Yang Clinical
Senior Manager, Global Business Category Candidates Characteristics Research Pre-
Development I II III
clinical
• Phone : +82-2-410-9087 Oraxol - Oral Paclitaxel with HM30181A KR: Gastric
• E-mail : [email protected] (Licensed-Out
- Reduced side effects, Neurotoxicity |cancer
WW ex. KR, IN)
Oratecan - Oral Irinotecan with HM30181A
Licensing In (Licensed-Out KR: Colon cancer
Brian Jo WW ex. KR, IN) - Increased efficacy & Reduced AE
Head of R&BD HM781-36B - pan-Her kinase inhibitor KR: N
 SCLC , Gastric,
Oncology (Licensed-Out China) - Her-2 & EGFR driven cancers & Breast cancer
• Phone : +82-2-410-9232
- EGFR mutant selective inhibitor
• E-mail : [email protected] HM61713 KR: NSCLC
- Reduced side effects
- RAF inhibitor
Export HM95573
- BRAF mut & N-RAS mut driven cancer
(Finished Products/APIs/CMO Business) KX2-391 - Src kinase / tubulin dual inhibitor KR: G
 astric & Breast
Steven Cho (Licensed-in) - Increased efficacy & Reduced AE cancer
Part Leader Auto - BTK inhibitor
HM71224 EU: RA
• Phone : +82-2-410-0462 Immune - Potent, selective & efficacious for RA
• E-mail : [email protected]

Information Management
· Company Hanmi Pharmaceutical. Co., Ltd.
Kyoung Woo Lee · CEO Gwan-Sun Lee
R&BD Manager · Specialty R&D based pharmaceutical products
• Phone : +82-2-410-9291 · Location 14, Wiryeseong-daero, Songpa-gu, Seoul, 138-724, Korea
• E-mail : [email protected] · Homepage www.hanmipharm.com

25
Pharmaceutical

HEALTHCARE INNOVATOR
HUONS CO., LTD.

Huons, started as Kwang Myung Pharm in 1965, has grown to a competent

global company, producing original and effective essential medicine and
medical products, through continual challenges and innovation over 50years.
Huons is putting a ceaseless effort for human healthy life without disease.
Our goal is to achieve 1billion USD in 2020 and aiming to be the TOP 10 global company at the industry in Korea.
To prepare the future, Huons built new factory in 2009. Huons has constructed state-of-the art manufacturing
facility in compliance with Korea, US and cGMP.
Huons is increasing the investment on innovative research and development.
KYNEX Eye-drop Huons, having obtained many patents as the results of its research, is not becoming complacent and is working
hard for development of new medicines, with the global pharmaceutical market entrance.
Huons has been producing Local anesthesia as major product and others, supplying it to more than 30countries
all over the world.
Huons has also been pioneering overseas markets and is making a big progress.

Foundation
MEDICAINE Injection · In 1965 (Established as a name of Kwang Myung Pharmaceutical)
· In 2003 (Changed its name as HUONS which means ‘HUman - MedicatiON - Solution”)
Specialty Business
· Manufacturing Pharmaceuticals (including Injections, Dental Anesthetics, Plastic Ampoules, Eye Drops)
· Well-being Products
· Medical Devices
ALLOON Tablet · CMO
· Domestic and Overseas Sales & Marketing

R&D Pipeline
Category Composition Indication Remark
HL-09 Magnoliae Cortex Ext. Fatty Liver P2
New Drug HSP23 Lonicera Japonica T. Ext. Sepsis P1
HU-017(NCE) IBD Pre-Clinical
Cyclosporine combination drug Dry eye syndrome Pre-Clinical
New combination drug Melasma Pre-Clinical
NSAID combination drug Acute low back pain Pre-Clinical
Amlodipine besylate 6.944mg +
IMDs Hypertension P1
Losartan K 100mg
Sildenafil combination drug Erectile dysfunction, premature ejaculation P1
Vitis vinifera Extract 50mg Hemorrhoidal, Phlebitis & Varicose Prep. P3
Sodium hyaluronate 60mg/3mL Osteoarthritis (Single injection treatment) Pre-Clinical
Biologics Botulinum toxin type A Temporary improvement of glabellar lines Pre-Clinical

Global business
· Exclusive Distribution Agreement with Alcon, US (Korean Branch) for Kynex and HE-10
· Exclusive Distribution Agreement with Spectra, USA for Lidocaine & Sodium Chloride
· Exclusive Distribution Agreement with Nipro, Japan for Lidocaine Ctg.
CONTACT US · Co-promotion with Kabi, Germany (Korean Branch) for Fresofol MCT Injection
· Exclusive Distribution Agreement with Biosyn, Germany for Selenase
Taek Keun, Yoo
(General Manager / Export team) · Company HUONS CO., LTD.
• Phone: +82-2-854-4700 · CEO Jae Kap, Jun
• Fax: +82-2-6455-0740 · Head Office 901 Pangyo innovalley C, 253, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
• E-mail : [email protected] · Homepage www.huons.com

26
 Pharmaceutical
The Company Which Has Dream of Healthy Society
Hyundai Pharmaceutical Co., Ltd.

With the long history since 1965, Hyundai Pharmaceutical Group (here after
HDP) has been growing up for the best R&D pharmaceutical company in
Korea and now heading to the world beyond Asia.
HDP is committed to creating the best value for mankind through its innovative product development, humanistic
management and social responsibilities. Through relentless pursuit of innovative effort, we have been given
for several renown awards such as Best Enterprise by Korean Management Association in 1984, the Best
Productivity Company among all listed companies in Korea in 1997, the President Award in National Safe and
Quality Management in 2005 and 2009 and lately selected as the Advanced technology center (ATC) and innovative
pharmaceutical company in 2012 by Korean government. With these recognitions, as well as our strengths in
manufacturing, qualified human resources and capabilities to develop innovative pharmaceutical products, HDP has
demonstrated and is now fully ready to go beyond Asian border ourselves and with our esteemed global partners.

Products
Therapeutic Class Product name Composition Indication Company
SYSCOR ER nisoldipine Hypertension Bayer
Cardiovascular ZESTRIL TAB anhydrous lisinopril Coronary Heart Disease
disease Astrazeneca
TENORMIN/TENORETIC atenolol/atenolol&chlorthalidone Hypertension
TAREG/CO-TAREG valsartan/valsartan and HCTZ Hypertension Novartis
LEVOTUSS SYR/TAB levodropropizine Acute and Chronic Bronchitis Dompe
Respiratory SURFOLASE CAP acebrophylline Acute and Chronic Bronchitis Poli
ALEGYSAL DRY TAB pemirolast potassium Allergy MTPC
ACTIC ORAL TAB fentanyl citrate Breakthrough cancer pain Teva
Central nervous TAMIRINE TAB galantamine hydrobromide Anti-Dementia
system PAXETIL TAB/CR TAB paroxetine HCl Antidepressant HDP
MIRAP TAB pramipexole dihydrocholoride Anti-Parkinson
NORLEVO 1 TAB levonorgestrel Emergency Contraceptive
Women’s ELLAONE TAB ulipristal acetate Emergency Contraceptive HRA
health
GYNOFLOR VAG TAB estriol, lactobacillus Vaginal Infection
TACHOCOMB aprotinin, collagen, fibrinogen, thrombin Hemorrhage during surgery
Hemostatics Takeda
TACHOSIL collagen, fibrinogen, thrombin Hemorrhage during surgery
Ophthalmologicals OCUVITE ascorbic acid, beta-carotene, etc. Supplement (OTC) Bausch &Lomb

R&D Pipeline
Criteria Products Indication Type DS PC Ph I Ph II Ph III NDA
HOB-046 Type2 Diabetes 11 betaHSDI
NCE HOB-047 Type2 Diabetes GPCR
HD-003 Chronic Renal Insufficiency Anti-oxidant
HOB-060 Obesity Natural compound
HOB-048 Cough Suppressant Peripheral antitussive
HOB-051 Bronchitis Mucos-active
IMD
HT-003 CNS Natural compound
BPS-015 Epilepsy Voltage-gated sodium channels
BPS-006 Gastroduodenal Ulcer Antiulcerant Mucosal Protection

CONTACT US
· Company Hyundai Pharmaceutical Co., Ltd.
Edward Kim
· CEO Chang Hyun, Yoon
Business Development Team Manager · Specialty Research and Development of new medicine and incrementally modified drug(IMD)
• Phone : +82-2-2600-3848 · Location Hyundai Pharm Bldg, Bongeunsa Street 135, Gangnam-Gu, Seoul, Korea
• E-Mail : [email protected] · Homepage http://www.hyundaipharm.co.kr

27
Pharmaceutical

Respect Humanity, Promote Human’s Health,

Improve Welfare
IL-YANG PHARMACEUTICAL CO., LTD.

IL-Yang will exert its efforts towards improving the national health and welfare
through continuous research and efforts for the development of the most
advanced medicines until all diseases in this land will be treated.
IL-Yang Pharmaceutical Co., LTD has tried its almost to manufacture superior medicines for the last half a century.
Since it took the first step to supply medicines in Korea, a barren land for the medical industry in 1946, IL-Yang
has been advancing into a top-ranking pharmaceutical company in the world with developing on GI, Hematology,
Vaccine, Virology area as well as vaccine plant established in April 2011 which has production capacity of
60mil doses per year. On the basis of the most advanced medical practice and pharmaceutical dispensing and
a solid business footing in Korean market. IL-Yang has exported a variety of pharmaceuticals to approximately
30 countries in the world including USA and Europe, and has opened an era of overseas branch production by
establishing YANGZHOU IL-YANG PHARM. CO., LTD. And TONGHUA IL-YANG HEALTH PRODUCTS CO., LTD. for
manufacturing end-pharmaceuticals in China.
Products
1. Supect (API: Radotinib)
1) 18th New Drug developed in Korea (4th in the world, 1st in Asia)
2) 2nd generation BCR-ABL1 tyrosine kinase inhibitor(TKI) for the treatment of Philadelphia chromosome
positive(Ph(+))CML
3) Indication: Ph(+) chronic myeloid leukemia (CML) in chronic phase (CP)
4) Development stage:
- 2nd line therapy for CML-CP NDA approved in Korea by MFDS in 5th JAN, 2012.
- Phase III for newly-diagnosed CML-CP is ongoing in Korea, Thailand, Indonesia, and Philippines
5) Key features
Supect - Low frequency serious adverse events
- Early and high response
- High overall survival rate
2. Noltec (API: Ilaprazole)
1) 14th New Drug developed in Korea
2) Noltec is a Proton Pump Inhibitor (PPI) that controls the secretion of gastric acid for the treatment of GU, DU,
GERD/EE, H. Pyrori and NERD
3) Expert Opinion: “Ilaprazole, developed to overcome the limitations of currently available PPI’s”
4) Key features
- Greater effect on Severe GERD/EE patients
- Low reoccurrence
- Cure symptoms of night time heartburn
- Low DDI
Noltec
3. Anti-Viral agent
IY7640 has been announced at American Society for Virology on 22 July, 2012 that it is 20~30 times potent than Tamiflu
R&D Pipeline
Compound Application Country Pre Ph I Ph II Ph III NDA Marketed
GU / DU Korea, China
GERD / EE Korea
Ilaprazole USA
NERD Korea
H.p eradication Korea
2nd line CML-CP Korea
Radotinib 1st line CML-CP Korea Ongoing
1st line CML-CP China Ongoing
Antiviral agent IY7640 Korea Ongoing
Respiratory Syncytial Virus Korea Ongoing
Virology Seasonal Flu vaccine Korea
Flu Quadrivalent Vaccine Korea Ongoing
Avian Flu Vaccine (H7N9) Korea Ongoing
CONTACT US
Sun Park. Ph. D. · Company IL-YANG PHARMACEUTICAL CO., LTD.
General Manager / Licensing Team · CEO DONG YEON, KIM
• Phone : +82-2-570-3787 · Specialty Urology, GI, Dermatology, Oncology, Vaccine, Biopharmaceutical
• Fax : +82-2-570-3890 · Location IL-Yang Bldg. 544-5 Dogok-dong, Gangnam-gu, Seoul, Korea
• E-Mail : [email protected] · Homepage www.ilyang.co.kr

28
 Pharmaceutical
Accumulation of High-value Core Technologies in Biotechnology
to Develop Future Products
ISU ABXIS

ISU Abxis is the leading Korean biopharmaceutical company which

succeeds in development on the first therapeutic antibody in Korea. ISU
Abxis provides the world-class products to MENA and Latin America
region and continues to expand its business portfolio by collaboration with
the US and EU based pharmaceutical companies.
Since 2001, ISU Abxis has established its own platform technologies and product pipelines with a desire of
being an axis of all therapeutic antibody industry as its name stands (ABXIS=AntiBody + aXIS). Beginning
with the successful development and market-launch of ISU’s first therapeutic antibody in 2006, ISU Abxis
has led Korean biopharmaceutical industry specialized in biosimilars and biobetters. Consequently in 2013
and 2014, ISU Abxis launched two biotherapeutics for orphan diseases of Gaucher and Fabry. ISU Abxis
has accumulated the world class manufacturing and QC/QA management through the full development and
manufacturing experiences in the globally harmonized compliance.
ISU’s three products, supplied to around 30 countries including Turkey, India, Algeria and Venezuela, are
available as the only alternative against the originator in the world. Furthermore, ISU Abxis operates the
mammalian production dedicated cGMP facility as obtained the GMP certificates from Turkey, Brazil, Colombia
and a number of major countries in Latin America and Middle East.
ISU’s excellent bio-technology expertise provides a global and local potential partner with (1) the higher
productivity at CMO level (2-5g/L), (2) development management system enabling the first-in-human IND from
the cell line development within 24 months, and (3) higher biosimilarity to its original product. Now ISU Abxis
also makes its great efforts in the development of novel biologics for the patients with cancer and hemophilia.
Besides the internal development activities, ISU Abxis recently does its best in importing and providing orphan
drugs for Korean patients who suffer the lack of treatment option.
ISU Abxis will grow its advanced technology based business for difficult-to-treat and orphan disease market
both domestically and worldwide.

Clotinab®
Product
Clotinab® (Abciximab)
· Indication: Adjunct to Percutaneous Coronary Intervention (PCI)
· The first therapeutic antibody developed in Korea and the world’s second Abciximab
· Launched in Korea in 2007 and exported to twelve countries including India, Turkey, Columbia, Venezuela and etc.
Abcertin® (Imiglucerase)
· Indication: Enzyme Replacement Therapy (ERT) for Gaucher disease (GD)
· The first drug for GD developed in Korea and the world’s second Imiglucerase
· Launcher in Korea in 2013 and under the registration in around 20 countries
Fabagal® (Agalsidase beta)
Abcertin® · Indication: Enzyme Replacement Therapy (ERT) for Fabry disease (FD)
· The first drug for FD developed in Korea and the world’s second Agalsidase beta
· Launched in Korea in 2014
Pheburane® (Sodium phenylbutyrate)
· Indication: adjunctive therapy in the chronic management of urea cycle disorders
· Imported product from EU (under the Korean registration)

R&D Pipeline (as of Mar. 2015)

Fabagal® Product 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Orphan Clotinab(Anti-thrombotic Treatment)
Drug Abcertin(Gaucher's Disease Treatment)
Fabagal(Fabry's Disease Treatment)
CONTACT US Biosimilar ISU103(Breast Cancer Treatment)

Juneyoung Park, Ph.D., VP ISU305(Paroxysmal nocturnal hemoglobinuria)

Business Planning & Development Novel ISU104(Hard-to-treat cancer Treatment)
• Phone : +82-31-696-4620 Drug ISU304(Hemophilia Treatment)
• Fax : +82-31-696-4690 R&D Non Clinical Clinical Launching Sales Tech Transfer
• E-Mail : [email protected]
· Company ISU Abxis Co., Ltd.
Minjeong Seong, Assistant Manager · CEO Daeseong Kim
Business Development · Specialty Biological pharmaceutics development based on the technology platform for biologics and animal cell culture
• Phone : +82-31-696-4631 · Location Global R&D Center, Bldg. C 5th Fl. , 22, Daewangpangyo-ro 712beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do,
• Fax : +82-31-696-4690 463-400, KOREA
• E-Mail : [email protected] · Homepage www.abxis.com

29
Pharmaceutical

Jump to the World

JW Pharmaceutical Corp.

JW Group provides pharmaceuticals vital for maintaining the lives of patients

such as anticancer drugs and antibiotics, and has developed into a leading
pharmaceutical company and global manufacturer of I.V. Solutions.
For almost 70 years ever since its foundation in 1945, we focus on healthcare, ETC, OTC, diagnostics, medical
equipment. Based on new technologies and services for healthy lives of human beings, JW Pharmaceutical has
built up strong sales network across the country and superior pipelines in I.V. solutions, antibiotics, oncology,
cardiology, endocrinology, rheumatology, and gout.

Major Export Products

Type Product Group
1. Carbapenem Antibiotics
2. Amino Acid Solutions
3. General I.V. Solutions & Other Sterile Solutions
4. Anticancer Agents
Finished Product 5. Antimicrobial & Antifungal Agents
6. Gastrointestinal Agents
7. Topical
8. Multivitamins
9. Agents for Antibiotics
10. Miscellaneous
1. Carbapenem Antibiotics: Imipenem/Cilastatin, Meropenem
API 2. Anti-fungals: Ketoconazole, Itraconazole, Fluconazole
(Active Pharmaceutical Ingredient) 3. Chiral Products for Custom Synthesis & Specialty Amino Acid
4. Miscellaneous

R&D Pipeline
JW is focusing on developing Biologics as well as Small molecules in the areas of oncology,
endocrinology and immunology by employing its novel platforms

Category Product Indication DS PC Clinical Trials NDA MKT

PI PII PIII
Acute myeloma lymphoma
CWP291
Multiple myeloma
URC102 Gout
NCE
Guardlet® T2DM
Contact Information THRUPAS ODT
®
BPH
ZEPEED® Erectile dysfunction
Business Development (Licensing) CreaVax RCC ®
Renal cell carcinoma
Kyunghee Kim CreaVax HCC® Hepatocellular carcinoma
Product Development Planning Biologics
CreaVax BC® Hepatocellular carcinoma
Product & Business Development Division CreaVax RA® Hepatocellular carcinoma
• Tel: +82-2-840-6703 Actemra® Rheumatoid arthritis
Actemra® SC Rheumatoid arthritis
• E-mail: [email protected]
Fixed-dose Livalo -V
®
Pitavastatin/Valsartan
combination Guard-Met Anagliptin/Metformin
Export URGO Dressing Wound healing
(APIs/Finished Products/CMO Business) Others URGO Filmogel Wound healing
John Lee WINUF Injection Total Parental Nutrition
Chief of Global Sales I ※ Pipeline represents progress of R&D programs since 2010
Global Business Division ※ CreaVax RCC® was approved as pharmaceuticals for export
• Tel: +82-2-840-6647
• E-mail: [email protected]

Research Planning
· Company JW Pharmaceutical Corporation
Sung Hwa Son
· President Kyung Ha Lee
Corporate Planning Office · Specialty I.V- solutions, antibiotics, cardiology, endocrinology, gastroenterology, nephrology, urology, and oncology
• Phone: +82-2-840-6935 · Location 2477 Nambusunhwan-ro, Seocho-gu, Seoul, Korea
• E-mail: [email protected] · Homepage www.jw-pharma.co.kr

30
 Pharmaceutical
Creating the Value of Health and Beauty
Kolmar Korea Co., Ltd.

Leading Korean Pharmaceuticals CMO company including Cosmetics and

Functional Health Foods.
Since founded in 1990 as a joint venture company with Nihon(Japan) Kolmar, Kolmar has grown to the biggest
Korean Pharmaceutical contract manufacturer.
Kolmar Korea has provided customized contract manufacturing service with customers who want to outsource their
pharmaceutical products, cosmetics and healthcare foods to be more competitive and to develop new formulations
feasible in the market.

Kolmar’s CMO Service on Pharmaceutical Business

All integrated services from the pharmaceutical development to analytical service and clinical Trial service do
distribution channel could be collaborated with Kolmar as it provides fast formulation development, scale up
manufacturing, strict quality control and just-in-time delivery.

R&D
Kolmar Korea reinvests more than 6% of net sales into its research and development, grafting 100 years’
worth of R&D know-how into research and development, and leading the latest trend by developing world-
class pharmaceuticals, health functional foods and cosmetics. Kolmar Korea has been approved not only in
domestic market but in international market for its great and predominant technology.

Global Kolmar
Kolmar Korea has its roots in the world-wide Kolmar Group. The Kolmar Group based on Kolmar Americas Inc.,
which is the parent organization of Kolmar Group and was established in Milwaukee, Wisconsin, in 1921, has
the world-wide network including Kolmar Japan, Korea, and China, showing off the vast scale in the world.
In the global network of Kolmar equipped with 100-year-old R&D know-how, the continuous information
exchanges are carried out through the regular symposium and academic activities by affiliated research group
members, so that latest data concerning marketing may be shared as well as technologies. Also Kolmar Korea
takes the initiative in the development history of world-wide pharmaceutical and cosmetic history.

Products
Kolmar Korea has a cutting-edge technology called ‘LIDCAPS’ that enables liquids to fill into hard-shell capsules.
The representative products taking advantage of the technology are Lidsen cap.(naproxen), cough-zero cap.,
Denti-lid cap.(Titrated extract of the unsaponifiable fraction of Zea mays L.), which have been approved by
KFDA first in Korea. Besides, Kolmar Korea’s product line-up covers virtually all the therapeutic areas such as
cardiovascular system (Amlodapine tab.), dermatologicals (Mitra cap.), genito-urinary system (Taminal cap.),
respiratory system (Pellium syrup.), alimentary treat (Panto-K tab.) and metabolism (Glimepirid tab.), etc.

R&D Pipeline
Category Candidate Indication Development stage
KKM0801 GI Ulcer Phase I
KKM1011 Hypertension Phase II
New Herbal Drug
KKM1012 Diabetes Phase II
Contact Information
KKM1102 Infections Preclinical
Moon-Su Pyo KKM0805 Osteoporosis Phase I
Small Molecules
Director / Global Business Dept. KKM0902 Osteoporosis Phase I
• Phone : +82-2-3485-0497 KKM1201 Hyperlipidemia Phase II
Combination Product
• Fax : +82-2-515-1532 KKM1202 Benign Prostatic Hyperplasia Phase III
• E-mail : [email protected]

Ms. Elena Ryu

· Company Kolmar Korea Co., Ltd.
Regional Manager / Global Business Dept. · CEO Hong-Koo CHO
• Phone : +82-2-3485-0397 · Specialty Pharmaceuticals/Cosmetics/Health Functional Foods
• Fax : +82-2-515-1532 · Location CNI BD 1596-3 Seocho-Dong Seocho-Gu Seoul Korea
• E-mail : [email protected] · Homepage http://www.kolmar.co.kr

31
Pharmaceutical

Otsuka-people Creating New Products for Better

Health Worldwide
Korea Otsuka Pharmaceutical Co.,Ltd.

Korea Otsuka Pharmaceutical is a branch of Otsuka Group International,

which was established in Korea in 1982. Korea Otsuka has set as its mission to
contribute to Korea’s healthcare industry, in line with which its main products
include “Abilify”, an antipsychotic medication, “Mucosta”, a medicine for
gastritis and gastric ulcer and “Pletaal”, an antiplatelet agent.
Korea otsuka Pharmaceutical (KOP) was started with the construction of the Hyangnam Plant back in 1989. The Plant
acquired KGMP(Korea good Manufacturing Practice) and BGMP(Bulk Good Manufacturing Practice) recognition in
1990 and 1999. In 2014,we gained recognition in Europe for our outstanding production capacity with EU-GMP and
expanded the scope of exports to Europe in addition to Asia and the Middle east, for the foremost base of Otsuka
Pharmaceutical.
As of 2014, KOP started promotion of UBIT and POCone, also is currently planning to launch a Perstymab, Deltyba
in this year.
On 2014, Otsuka Pharmaceutical signed a five-year extension of a Memorandum of Understanding(MOU) wit of
South Korea’s Ministry of Health and Welfare for cooperation a Memorandum, With the initial agreement signed
on September 9,2009 in order to the domestic development of new products and the advancement of local R&D
infrastructure.
Korea Otsuka Pharmaceutical has a world-class level of technological power, built upon the systematization of
manufacturing facilities and the advancements made in its business processes and synthesis technologies. It
currently exports the materials/finished medicines produced with its competitive, technical strengths to Japan
and Europe and 10 countries within Southeast Asia. With other multinational pharmaceutical companies tending
Mucosta Tab. to look to close down their factories, Korea Otsuka Pharmaceutical is bucking this trends, with plans to expand
its exports and diversify its exporting regions by establishing a firmer foothold, with a production base that covers
Asia and Middle East, including its synthesis plant for Rebamipide, which was completed in October 2003.

Business
Abilify Tab. Korea Otsuka Pharmaceutical has production facilities based in Korea, contributing to its exports to 10
countries, including Japan, China, Philippine and Indonesia. In fact, the company has produced a medicine for
global clinical trials, which requires a high-level of technology, and successfully exported this to Japan in 2011.
Korea Otsuka Pharmaceutical’s differentiated clinical development, exports and its role:
1) Korea Otsuka Pharmaceutical has amplified the advantages of clinical development environment of Korea-
China-Japan, improved the efficiency of new medication development and contributed to better healthcare
Pletaal Tab. service for Asian by developing a cure for endemic disease in relevant country
2) A development center for anti tuberculosis drug and diagnosis/medicine-taking model
3) Korea Otsuka Pharmaceutical has developed medications best suited for the country (obtained approval for
pharmaceutically modified drug, Platelet SR drug and for the world’s first approval for Abilify tablet being
efficacious for Indication of child’s diseases through clinical trials with in the country)
4) As a Korean company exporting its products to overseas, Korea Otsuka Pharmaceutical has made a great
(26.4 billion won in 2012 and 23.2billion won in 2013, 28.5 billion won in 2014)
CONTACT US
R&D/Export/Product
Han Taegyu
Clinical Development Team
• Phone : +82-2-3287-9203
· Company Korea Otsuka Pharmaceutical Co.,Ltd.
Others · CEO Moon, Sung-ho
Kim Taejin · Specialty The manufacture, sale, import and export of pharmaceuticals and pharmaceutical products
Planning Team · Location 770-9 Yeoksam-dong, Gangnam-gu, Seoul, Korea
• Phone : +82-3287-9124 · Homepage www.otsuka.co.kr

32
 Pharmaceutical
KUP is a Glabal Pharmaceutical Company All
around the World
Korea United Pharm. Inc.

Company Profile
· Establishment Date : Dec. 3, 1987 · Market Sales : $136M (2014)
· Number of employees:738 (Jan. 01, 2015) · Growth Rate from 2013 to 2014 :10.3%
· Investment in R&D : 12.6% of net sales (2013) · Number of registered products : about 224 items
· Incrementally Modified Drug : Clanza®CR, Clavixin®Duo Cap, Cilostan®CR, Kalomin®Tab.

KUP is export-oriented company. KUP is aiming to be not only a local leader but also global leading company
by offering wide range of generics as well as differentiated products, incrementally modified drugs.
KUP has broad and well balanced portfolio of 244 products and exports 416 different items to 32 countries
through global marketing, and oversea manufacturing facilities in USA, Vietnam, and has a business alliance
with oversea companies. Especially KUP established manufacturing facility in Alabama, US for manufacturing
and distrubuting drugs and health functional foods in 2003. This facility have allowed KUP to expand markets
Clanza®CR Tab.
in US, Japan, and Europe with know-hows of FDA regulatory processes.
KUP invested in Research&Development. KUP invested about 12% of net sales and 10% of total employees
in R&D continuously. KUP is successful developing innovative drugs and commercializing it. As a result, KUP
has launched four IMDs - Clanza®CR Tab., Calvixin®Duo Cap., Cilostan®CR Tab., Kalomin®Tab. In addition, KUP
has well balanced R&D portfolio including differentiated products of anti-neoplastic, Anti-hypertensive, and
Antithrombotic Dugs.
KUP has been acknowledged at home and abroad. KUP was nominated as Forbes’ ‘Asia’s 200 Best Under A
Clavixin®Duo Cap.
Billion’ over two consecutive years. KUP is one and only pharmaceutical company in Korea nominated by the
Forbes magazine as one of the ‘Asia’s 200 Best Under A Billion’ over two consecutive years (2009~2010). KUP
was awarded the Best Drug Research Award in Korea for CilostanCR in 2015.

Main Products (IMD Products)

Product (Ingredient/Formulation) Remark
Cilostan®CR Tab. · Indication : P ain caused by rheumatism
1. Clanza®CR Tab. (Antiinflammatory Analgesic drug)
(Aceclofenac 200mg/ · Improved dosing regimen from b.i.d. to q.d.
Controlled Release Formulation) · Less side effects of gastrointestinal
2. Cilostan®CR Tab. · Indication : Ischemic symptoms, Thrombosis
(Antithrombotic durgs)
(Cilostazol 200mg / · Improved dosing regimen from b.i.d to q.d.
Controlled Release Formulation) · Reduced side effects of headache & tachycardia
3. Clavixin®Duo Cap. · Indication : A
 cute coronary syndrome
Kalomin®Tab.
(Clopidogrel 75mg and Aspirin 100mg / (Antithrombotic durgs)
Fixed Dose Combination) · Improved patient compliance
4. Kalomin® Tab. · Indication : U pper respiratory tract infections
(Pelargonium Sidoides(as dry extract) 20mg / (Antitussive)
New Dosage Formulation) · Improved patient compliance for adults

R&D Pipeline
Compound Name Code Use Stage of Developmen
Unigril®CR Tab. UI03SPG300CT Antithrombotic durgs Clinical Trial
Levonazine®CR Tab. UI04LDP090CT Antitussive Clinical Trial
Losasc® Tab. 5/50, UI15AML055MT Anti-hypertensive Clinical Trial
Losasc® Tab. 5/100 UI18AML0510MT
DTX031 UI19DTX031IV Anti-neoplastic Clinical Trial
Gastin®CR Tab. UI05MSP015CT GI modulator Clinical Trial
Contact Information
Sayong Hong, Department Manager, · Company Korea United Pharm. Inc.
Department of Business Development & · CEO Duk-Young Kang
Licensing · Specialty Business Manufacture, Marketing & Sales of Pharmaceuticals and Other Healthcare Products
• Phone : +82-2-558-8612 · Location 25-23, Nojanggongdan-Gil, Jeondong-Myeon, Sejong, Korea
• E-mail : [email protected] · Homepage http://www.kup.co.kr

33
Pharmaceutical

Global pharmaceutical company committed in

providing better quality of life for people.
Kuhnil Pharm., Co.., Ltd.

Kuhnil Pharm continues to strive to become an unique research-focused global

company through development of innovative global biopharmaceuticals,
DDS pharmaceuticals, and combination drug products in an effort to improve
quality of life in patients.
In 2014, Kuhnil received sales approval of 'Circadin' which is the world's only insomnia treatment with the ingredient of
melatonin to the Ministry of Food and Drug Safety. Kuhnil has also adopted an unique strategy of advancing into a new
and niche areas of pharmaceutical development such as development of a world's first approval of Omacor's new indica-
tion called IgA nephropathy as well as developing new indication in the treatment of ulcerative inflammation of the small
intestine, for a novel GI drug.
In 2005, Kuhnil participated in the clinical program for innovative biopharmaceutical, TheraCIM, in the treatment of
NSCLC, subsequently collaborating with Daiichi-Sankyo to initiate the phase 3 trial for gastric cancer in Korea and Japan
in the 2nd half of 2012. In addition, Kuhnil has partnered with foreign CROs for the development of interferon-ß biosimilar.
A subsidiary Company, Penmix, specializes in penicillin formulation manufacturing. With the opening of Kuhnil's new
cGMP injectable formulation manufacturing facility, Kuhnil envisions to become a global CMO company reaching market
Amocla/Amocla Duo
Tab/Syr/inj
abroad including Japan and EU, particularly, utilizing Kuhnil's know-how in the areas of lyophillization process.
Products
Kuhnil Pharm possesses pharmaceutical products in a wide selection of therapeutic areas including antibiotics, circula-
tory, gastrointestinal, anti-inflammatory, CNS, respiratory, and endocrinology. Penmix, a subsidiary company of Kuhnil
Pharm, was recognized for excellence in quality through exportation to all over the world including Japan, Malaysia,
Tabaxin inj. Singapore, Vietnam, and etc.
Product Content Major Export Country
Amocla/Amocla Duo Tab/Syr/inj Amoxicillin Malaysia/Singapore/Vietnam
Pot.clavulanate * Export, 2012Y: 0.5m$
Tabaxin inj. Piperacillin sodium Philippine, Vietnam
Tazobactam * Export, 2012Y: 0.06m$
Antibiotics Acibactam Inj. Amoxicillin Sodium Vietnam
Piperacillin Inj. Sulbactam Sodium * Export, 2012Y: 0.04m$
Piperacillin Inj. Piperacillin Sodium Japan
* Export, 2011Y: 8.3m$
Pentacillin Inj. Ampicillin Sodium Japan/Vietnam/Philippine
Sulbactam Sodium * Export, 2011Y: 14.0m$
Cardio Vascular Omacor Cap Omega-3-acid ethyl esters
Hypnotics Circadin Tab melatonin
Pentacillin Inj.
Pulmican Respule Budesonide micronized
Respiratory Formerol Dry Syr. Formerol Dry Syr.
Formoterol fumarate Formoterol fumarate
Thiosina Tablet Thiocolchicoside
Muscle relaxants Amorphous aescin
Pulmican Respule
Lodine kuhnil Cap/Tab/SR Tab Eodolac Micronized
Wellcon Tab. Calcium polycarbophil
Gastrointestinal
Bioflor 250 Pow Saccharomyces boulardii

Thiosina Tablet
R&D Pipeline
Product Indication Preclinical Phase I Phase II Phase III Launch
Oncology
KI 0501 Stomach Cancer P3
KI 0508 Pancreatic Cancer P3
QOL
KI 1001 Insomnia Launch
KI 239 Female Sexual Desire Disorder Preclinical
KI 208 Night Eating Syndrome Preclinical
KI 251 Premature Ejaculation Preclinical
Cardio Vascular
KI 1105 Dyslipidemia P1 P3
KI 1106 Dyslipidemia Preclinical
KI 1107 Dyslipidemia Preclinical
Dental
KI 1209 Periodontitis Preclinical

· Company Kuhnil Pharmaceutical Co.,Ltd

CONTACT US · CEO Kim Young Joong
· Specialty Development, Manufacturing, and Distribution of Various Pharmaceutical Products including Oral
YongNam Jang Business Dosage Forms, Injectables, Inhalers, etc.
R&D Center / Team Manager · Head Office OhSong B/D, 14, Jeongdong-gil, Jung-gu, Seoul, Korea, 100-120
• E-mail : [email protected] · Homepage www.kuhnil.com

34
 Pharmaceutical
Leading Global Life Science Company
LG Life Sciences, Ltd.

The First Pioneer in Korean Pharmaceutical R&D Products

LG Life Sciences is Korea’s leading biopharmaceutical company. One of LG Group affi liate, demerged from LG
Chem in 2002. LGLS is leveraging its proven R&D capabilities to develop world-class products, Factive®, the only
US FDA approved novel chemical drug, as well as Valtropin®, the fi rst biosimilar approved by the EMEA and US
FDA developed in Korea. LGLS is building a network of strategic alliances to extend its R&D and marketing reach.
Products
Factive® - Fast Active, the most potent quinolone antibiotic in the world, commercialized in over 30 countries worldwide
Zemiglo® - A novel dipeptidyl peptidase IV (DPP IV) inhibitor for T2DM with good efficacy and safety profiles.
Approved by the KFDA in June, 2012
Eutropin® - T he right choice for managing short stature recombinant human growth hormone with proven efficacy and
safety since 1993
Espogen® - Human recombinant erythropoietin, safe and effective treatment for anemia of chronic renal failure
Follitrope - R ecombinant FSH, used in the treatment of female infertility in controlled ovarian hyperstimulation to induce
®

Factive® the development of multiple follicles in a medically assisted reproduction program as well as anovulation
Hyruan Plus® - High molecular weight hyaluronic acid viscosupplement made by microbial fermentation for low side-effect,
quality proven by EMEA and CE marking

R&D Pipeline
SR-hGH - T he world’s fi rst once-a-week human growth hormone, US NDA has been fi led for adult and multinational
phase III trials are fi nished for pediatric GHD
Monoclonal Antibody Biosimilars - Enbrel, Humira and Avastin biosimilars are undergoing active development
Declage®
1) Chemicals
Clinical Trial
Class Product Indication DS PC NDA
PI PII PIII
LC280126 Myocardial Infarction ○
LC350189 Hyperuricemia, Gout ○
LC51SPA Multiple Sclerosis ○
Eutropin plus® NCE
LC52CIS Type 2 Diabetes ○
LC54AID3 Metabolic Disease ○
LC53LEOH Multiple Myeloma ○
ZV Combi Hypertension ○
VR Combi Hypertension / Hyperlipidemia ○
ZemiMet Type 2 Diabetes ○
IMD*
ZemiSU Type 2 Diabetes ○
Zemiglo®
ZemiStatin Diabetes / Hyperlipidemia ○
ZemiARB Diabetes / Hypertension ○
*IMD = Incrementally modified drugs

2) Biologics
Clinical Trial
Class Product Indication DS PC NDA
Euvax B® PI PII PIII
Biobetter LB03002 GHD (global) ○
LBEC0101 Rheumatoid Arthritis ○
LBAL Rheumatoid Arthritis ○
Biosimilar
LBDP Anemia ○
LBBZ Colorectal Cancer ○
DTwP-HepB-Hib (liquid) D/T/P/HBV/M ○
LBFL0101 Influenza ○
Vaccine LBVC Poliomyelitis ○
LBVD D/T/P/HBV/M/IPV ○
LBVE Pneumonia ○
LBSA0103 Osteoarthritis ○
HA-based Product
YVOIRE contour Plus Soft Tissue Augmentation ○
CONTACT US *HA = Hyaluronic acid
· Company LG Life Sciences, Ltd.
Jong-heon Won, Manager · CEO Il-Jae Jung
Business Development Team · Specialty New chemical entity, biosimilar, Diagnositcs
• Phone : +82-2-6924-3233 · Location LG Gwanghwamun Bldg. 92, Sinmunno-2ga, Jongno-gu, Seoul, Korea
• E-Mail : [email protected] · Homepage www.lgls.com

35
Pharmaceutical

Toxin, Filler and Even More

Medytox

We are at the forefront of Korean biopharmaceutical industry, thanks to our

excellent R&D capabilities based on our top-tier biotechnologists, and to our
state-of-the-art operations and production facilities. Moreover, we are going to
become a trailblazer in the field of biotechnology due to our passion and courage
to embrace global challenges.
Since Botulinum Toxin Type A Neuronox (Neuronox is also being sold worldwide under different brand names
such as Siax, Botulift, Cunox and Meditoxin) was launched in 2006, Medytox has shown a dramatic growth.
Since 2009, we have ranked No. 1 market share in Korea and reached near 40% of market share. As more diverse
indications are added, it appears that our market share would further increase.
Our company has successfully developed the fourth botulinum toxin biopharmaceuticals in the world. We are
exporting the products to about 50 countries, including Japan, Thailand, India and Brazil. We are also expecting to
be a leading global biopharmaceutical company after entering the North America and EU markets in 2016.

Main Products
1. Botulinum Toxin Type A product
Medytox’s core business area is manufacturing botulinum toxin type A biopharmaceuticals, Neuronox. It is
widely used not only in the cosmetic field, including facial wrinkle reduction, but also in the therapeutic field,
for people with blepharospasm, cerebral palsy, etc.

Nueronox® 2. Hyaluronic Acid Dermal Filler

Medytox’s hyaluronic acid filler, Neuramis is currently being used in the field of cosmetics to smoothen deep
and fixed wrinkles on skin tissue. Also, it is used as therapeutic agent for surgery and for treatment of arthritis.
As a partner product, it could maximize a synergy effect along with Medytox’s core product Neuronox.

R&D Pipeline
Fueled by the success of Nueronox, we plan to perform a basic study for the development of innovative bio
pharmaceuticals to heal degenerative arthritis, senile ocular disease, skin disease and cancer. We have
strengthened base technology in protein engineering, antibody engineering and cell biology by recruiting
talented personnel. As the first achievement, we have completed basic verification studies on degenerative
arthritis and senile ocular disease (MT202 and MT401). It appears that they would enter into the pre-clinical
phase in 2013. We plan to keep making investments with a long-term vision to be a global biopharmaceutical
leader through development of innovative drugs.

CONTACT US
Ochang Headquarters/Microbial
Toxin R&D center
• Phone : +82-70-8666-7520
• Fax : +82-43-217-1557
• E-Mail : [email protected]
· Company Medytox
· CEO Jung Hyun Ho
Seoul Office · Specialty Botulinum toxin products, Medical aesthetics, Bio-pharmaceuticals
• Phone : +82-2-3471-8319 · Location 641-4 Gak-ri, Ochang-eup, Cheongwon-gun, Chungbuk 363-883, Korea
• Fax : +82-2-3471-8374 · Homepage www.medytox.com

36
 Pharmaceutical
For the Health Life and Fruitful Future
Samjin Pharmaceutical Co., Ltd.

Since its establishment in 1968, we, Samjin Pharm Co., Ltd. have strove our
utmost efforts for producing qualitative pharmaceuticals and investing to
research for the development of a new drugs with a philosophy of company
that “Respect for human life”.
GMP Factory
T he manufacture of pharmaceutical products is the most important field of pharmaceutical industry as well as
research and development. The production of pharmaceutical products, which demands the utmost precision
and professionalism is a standard to evaluate the level of the pharmaceutical company. The manufacturing
factory supports Samjin Pharmaceuticals’ advanced technology as well. In order to maintain the precision of
manufacturing the pharmaceuticals, which is sensitive to all kinds of qualification, Samjin Pharmaceutical
plant has been operated with the scientific and automatized system in all manufacturing processes.

Products
Samjin Pharmaceutical is a comprehensive pharmaceutical company of developing, manufacturing and
marketing finished products and APIs in the worldwide market.
The representative products, “GEWORIN Tablet” has been occupied significant market share in analgesic
market in Korea, and Samjin Pharmaceutical has continuously developed a marketing strategy for potential
increase in sales and profits with high quality generic pharmaceuticals such as anti-platelet agent “PLATLESS
Tablet (Clopidogrel 75mg Tablet)” and Clopidogrel Bisulfate (crystal form 1).
Samjin Clopidogrel Bisulfate (crystal form 1) has excellent physico-chemical properties for the direct
compression such as narrow particle size distribution, good flowability and good bulk density.

R&D Pipeline
1. Development of anti-HIV agent : SJ3366
S J-3366(IQP-0528) is a unique and highly potent new nonnucleoside reverse transcriptase inhibitor of human
immunodeficiency virus type 1(HIV-1) that also inhibits HIV-2. Also its product is a novel candidate for a vaginal topical
microbicides, currently being performed with preclinical study against formulation both a gel and an intravaginal ring.
2. Development of anticancer agent : SJ3902
S J-3902 Series is a novel, highly potent and safe anticancer agent with unique mechanism of action and
chemical structure suggesting the first member of new pharmacology class of tumor cell cycle interrupt on
oncology field. The compound exhibits microtubule-interfering (G2/M), apoptosis, and inhibition of angiogenesis.
3. Development of anti-dry eye agent : SA001
S A001(prodrug) is novel anti-dry eye drug candidate with unique mode of action which is very effective to all stage of
dry eye syndrome by increasing tear volume and anti-inflammatory action through stimulating mucin secretion in the eye
4. Development of anti-diabetes agent : SJ8093
 SJ8903 is a novel sodium-glucose co-transporter-2(SGLT-2) inhibitor as a potential anti-diabetic agent.
The compound reduces blood glucose level by blocking glucose reabsorption in the kidney and thereby
stimulating excretion glucose via the urine.
5. Development of anti-cancer agent : SI001
SI001 is a target specific anti-cancer agent with an excellent Pan-RAF and VEGFR2 dual inhibitory activity.
CONTACT US The mode of actions of SI001 is dual inhibition of mutant RAS-RAF signaling in colorectal cancer cells and
angiogenesis in vascular endothelial cells.
Bum Kyu, Shin
General Manager, · Company Samjin Pharmaceutical Co., Ltd.
Overseas Business Department · CEO Sung Woo, Lee
• Phone : +82-2-3140-0673 · Specialty Manufacture, Marketing and Distribution of Pharmaceutical Products (Finished Products and APIs)
• Fax : +82-2-392-5315 · Location 338-8, Seogyo-Dong, Mapo-Gu, Seoul, Korea
• E-Mail : [email protected] · Homepage www.samjinpharm.co.kr

37
Pharmaceutical

Innovative Specialty Pharmaceutical Company

Samyang Biopharmaceuticals
Corporation.

Samyang Biopharmaceuticals Corporation, with its central research center is engaged

in the development and marketing of novel drug delivery systems and medical devices.
Samyang Biopharmaceuticals Corporation is focusing its efforts on healthcare as its core strategic business of the
21st century. Samyang Biopharmaceuticals Corporation is developing proprietary and unique core technologies for the
development of world class novel drug delivery systems.

Main Products
Active
Category Products Strength / Grade Comment
Ingredient
Genexol PM
®
Paclitaxel 30mg, 100mg · Cremophor-free, Ethanol-free formulation
Nanoxel® M Docetaxel 20mg, 80mg · Tween-80 free formulation (No diluent vial)
Zolenic® Zoledronic acid 4mg / 5mL · Launched in Korea & Georgia
Paclitaxel 30mg / 5mL, 100mg / 16.7mL · Launched in EU (Working as CMO)
Injection 150mg / 25mL, 300mg / 50mL · All dossiers are ready for approval procedure
Generic Docetaxel 20mg/1mL, 80mg/4mL · Launched in EU & Japan (Working as CMO)
140mg/7mL, 160mg/8mL
Oxaliplatin 30mg/5mL, 100mg/16.7mL · Launched in EU (Registered in DE, BG, RO, UK)
150mg/25mL, 300mg/50mL · MRP running for other EU members
Fentaderm ®
Fentanyl 12㎍/hr, 25㎍/hr, 50㎍/hr · Reduced API (50%) with same PK as original
Patch
DemenCure® Rivastigmine 4.6mg/day, 9.5mg/day · Reduced API (66%) with same PK as original
Paclitaxel EP, USP · CEP completed
API
Docetaxel EP, USP · CEP completed

GMP Certifications
Year Product Inspection Authorty
2014 Paclitaxel (API), Docetaxel (API), Germany (BGV)
Synthetic Paclitaxel (API), Pemetrexed (API)
2013 Docetaxel (API) Japan (PMDA)
2012 Oncology Injections Germany (BGV)
Oncology Injections Japan (PMDA)
2010 Paclitaxel (API) Japan (PMDA)
Diclofenac Patch Australia (TGA)

R&D Pipeline
Category Technology Description Products Development Status
Genexol® PM Marketed
Polymeric Micelle Nanoxel® M Marketed
Temsirolimus Non-clinical
Injection Docetaxel-PNP Clinical (Phase I)
Polymeric Nano-Particle Voriconazole-PNP Clinical (Phase I)
Long Acting Micro-Particle Goserelin Non-clinical
CONTACT US Capsaicin Clinical (Phase II)
TDS Fentaderm® Marketed
Trans-dermal
Overseas Pharmaceuticals Sales (Transdermal Drug Delivery System) DemenCure® Approved
Mr. Jae-Wook Joo Buprenorphine Under development
Team Leader, Overseas Business Team Oral BA enhancing Celecoxib Non-clinical
Plant Cell Culture Paclitaxel Marketed
• Phone : +82-2-740-7163
Fermentation Epothilones Pilot production
• E-mail : [email protected] Sirolimus Under development
Fermentation / Organic Synthesis Liraglutide Under development
API
API Sales Paclitaxel Marketed
Docetaxel Marketed
Mr. Jeong-Hwan Yun Organic Synthesis Pemetrexed Marketed
Senior Manager, Overseas Business Team Bortezomib Pilot production
• Phone : +82-2-740-7914 Cabazitaxel Under development
• E-mail : [email protected]

Business development
· Company Samyang Biopharmaceuticals Corporation.
Mr. Gun Seomoon · CEO Taeung Eom
Senior Manager, Overseas Business Team · Specialty Oncology, GMP Manufacturing(APIs, Injections, Patches), DDS Technology
• Phone : +82-2-740-7268 · Head Office 31, Jong-ro 33-gil, Jongno-gu, Seoul, 110-725, Korea
• E-mail : [email protected] · Homepage www.samyangbiopharm.com

38
 Pharmaceutical
We Fulfill Your Healthy Dreams
sanofi-aventis Korea

SANOFI IS A GLOBAL HEALTHCARE LEADER FOCUSED ON

PATIENTS’ NEEDS
engaged in the research, development, manufacturing and marketing of innovative therapeutic solutions.
Sanofi has core strengths in healthcare, with 7 growth platforms: diabetes solutions, human vaccines,
innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is
listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
In Korea, Sanofi has four legal entities in the fields of pharmaceuticals and consumer healthcare (sanofi-
aventis Korea), vaccines (Sanofi Pasteur), rare disease (Genzyme Korea), and animal health (Merial Korea).
sanofi-aventis Korea has recognized Korea’s emerging excellence in basic research and sought ways to
Plavix® expand collaboration under “Open Innovation” strategy. Accredited as Innovative Pharmaceutical Company
in 2014, sanofi-aventis Korea has established and looked forward to seeking out partnerships with promising
pharmaceutical companies, bio-techs, clinical research centers as well as academia in Korea to bring
innovation where high unmet patient needs exists, while continuously investing in clinical development of
new medicines and help Korean partners go global.

Lantus®
Products
Plavix®
Atherosclerosis symptoms
Lantus®
Diabetes
Aprovel®
Essential hypertension, Renal disease in type 2 diabetes with hypertension
Aprovel®
Eloxatin®
Colorectal cancer, stomach cancer, pancreatic cancer
Taxotere®
Breast cancer, stomach cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, esophageal
cancer and prostate cancer

Eloxatin® R&D Pipeline

Myelofibrosis, Articular cartilage defects, Muscular atrophy, Diabetes, Rheumatoid arthritis, Dyslipidemia,
Atopic dermatitis and Asthma

History
1973 Founded Sanofi
Taxotere® 1991 Established Sanofi Korea
2004 Established sanofi-aventis Group
2005 Established clinical R&D unit under direct control of corporate headquarters
2006 Started sanofi-aventis Korea
2010 Launched Cenovis, the consumer healthcare brand
CONTACT US 2012 Started Sanofi Group Integrated Management Committee
2013 Received Family-Friendly Company Accreditation by MOGEF
R&D Collaboration 2014 Received Innovative Pharmaceutical Company by MOHW
Dr. Sung Joo Lee
Head of Research, TSU Asia Pacific R&D
• Phone: +82-42-863-9205
• E-mail : [email protected] · Company sanofi-aventis Korea
· CEO Kyung-Eun (Kay) Bae
Global Business Development · Specialty Diabetes, Oncology, Cardiovascular Disease, Internal Medicine, Central Nerve System, Infectious Disease,
Ms. Soo Youn Chang and Rheumatoid arthritis
Head of Strategy & Business Development · Tel +82-2-2136-9000
· Fax +82-2-2136-9099
• Phone: +82-2-2136-9010 · Location 235, Banpo-daero, Seoch-gu, Seoul
• E-mail : [email protected] · Homepage www.sanofi.co.kr

39
Pharmaceutical

pharmaceutical company with the Top-level

sales of prescription drugs in the Surgery market
Shin Poong Pharm.Co.,Ltd

Shin Poong is the pharmaceutical company with the No. 1 sales of prescription
drugs in the Surgery market.
Under the management philosophy of ‘for the health of the people’, Shin Poong Pharm.Co.,Ltd specializes
in manufacturing remedy drugs with sincere efforts put into producing every single tablet of life-saving drugs
ranging from ingredients to finished products based on our state-of-the-art manufacturing facilities and quality
assurance system. We are committed to realizing the spirit of Shin Poong 3V(Vision,Venture and Victory) with
top- notch competitiveness based on in-house ingredient synthesizing technologies obtained through rigorous R&D
efforts and to further developing the company into the one that receives confidence from our customers and that
contributes to promoting the wellbeing of human beings.

In 2011, Shin Poong developed PYRAMAX® in cooperation with Medicines for Malaria Venture and approved by
Korean FDA. PYRAMAX® is the first artemisinin combination therapy to receive an Article 58 positive scientific
opinion from EMA for treatment of both strains of malaria : P.falciparum and P.vivax, in adults and children over
20kg and was listed on WHO prequalified medicines in may 2012.

Main Products
Name Indication Phase Classification
Pyramax Tab. Anti-malaria On Market NME
Loxfen Tab NSAIDs On Market Generic
Hyal Forte Inj Osteoarthritis On Market Generic
Clamoxin® Clamoxin Tab. Anti-biotics On Market Generic
Medicurtain Inj. Adhesion Barrier On Market Medical device

R&D
Medicurtain® Category Products Indication Stage
Pyramax Tab. Anti-malaria Launch(Korea) Registration(EMA)
Pyramax Gran. Anti-malaria Phase 3(Asia, Africa)
NME
SP-8203 Anti-stroke Phase 1 (US/Korea)
SP-35454 Osteoporosis Phase 1 (Europe)
SP5M001 Osteoarthritis Phase 1(Korea)
Hyal Forte inj.
SP3R001 Anti-histamine Phase 1(Korea)
SP3C001 Hypertension Phase 2&3(Korea)
IMD
SP3C002 Hyperlipidemia Phase 3(Korea)
Loxfen Inj. NSAIDs Registration(Korea)
Derma filler Derma filler Pre-clinic(US/Korea)-Medical device
Pyramax Tab.
※ New Molecular Entity, Incrementally Modified Drug

CONTACT US
· Company SHIN POONG PHARM.CO.,LTD
Contact Information · CEO JEI MAN RYU
Paul Choen, Director · Specialty Business Manufacture and Sales of the pharmaceutical products
• Phone : +82-2-2189-3471 · Head Office 748-31 YOKSAM-DONG, KANGNAM-GU, SEOUL, 135-925, KOREA
• E-mail : [email protected] · Homepage www.shinpoong.co.kr

40
 Pharmaceutical
Developing Premium Vaccines, New Chemical Entities, Biopharmaceutical Drugs
SK Chemicals Co. Ltd.

SK Chemicals contributes to ehance human health and the quality of life

by developing new synthetic drugs, premium vaccines and innovative
manufacturing technologies.
SK Chemicals opened a new chapter in the history of the Korean pharmaceutical industry in 1999, when it
succeeded in launching SUNPLA, Korea's and the world's first third generation platinum complex cancer drug.
In 2007, the company launched the world's fifth PDE5 inhibitor, a novel erectile dysfunction agent in Korea. In
2011, it also succeeded in commercializing the world first orally dissolving film (ODF) formulation containing
the PDE5 inhibitor.
In particular, the platform technology of manufacturing not only ODF formulation but also transdermal patch
formulation had made SK Chemicals as a leader in developing incrementally modified formulation drugs. As a
result, dementia patch called SID710 was successfully approved for sale in Europe. SK Chemicals is actively
marketing and exporting the product to major markets.
In the virtue of ceaseless investment to its R&D activities, SK Chemicals now possesses a wide range of R&D
portfolio from premium vaccines and plasma derived products to recombinant protein drug. Particularly, the
next generation technology of cell-culture based vaccine, it succeeded in obtaining the Korea's first marketing
Sunpla injection authorization of cell-culture technology based influenza vaccine. As a part of continuous commitment to vaccine
R&D, it also completed building a state-of-the-art vaccine manufacturing plant in Andong city. As a result, the
company already entered into a couple of major licensing agreements with multinational organizations.
Main Products
Product Information
Sunpla injection Anti-cancer agent
(3rd generation platinum complex anti-cancerdrug) *The 1st Korean new chemical entity
Trast patch (Piroxicam) Patch formulation with anti-inflammatory
Trast Patch Joins (Clematis mandshurica, Trichosanthes Killilowii, Cartilage protective agent
Prunella vulgaris ext) *The 1st Korean new herbal drug
Mvix (Mirodenafil) Treatment of erectile dysfunction (ED)
Rivastigmine patch Patch formulation for Alzheimer’s disease exporting worldwide
Prevention for influenza virus
SKYCellflu *The 1st Korean cell culture influenza vaccine

R&D Pipeline
SK Chemicals focuses on developing premium vaccines, new chemical entities, and
Joins biopharmaceutical drug in therapeutic areas with high unmet medical needs.
Product Indication Description Status
NCE401 Fibrosis New Chemical Entity Preclinical
NCE403 Endometriosis New Chemical Entity Phase I
NCE406 Diabetes New Chemical Entity Preclinical
NCE407 Multiple sclerosis New Chemical Entity Screening
YKP Irritable bowel syndrome New Chemical Entity Phase II
NBP601 Hemophilia Bio-better Multinational, pre-registration
NBP602 Hepatitis B immunoglobulin Plasma product Registration
NBP604 Haemophilia Bio-better Preclinical
Mvix NBP606 Pneumococcal diseases Vaccine Pre-registration
NBP607 Seasonal cell culture flu Vaccine Approved in 2014
NBP608 Herpes zoster Vaccine Registration
Varicella Vaccine Phase III
NBP - Vaccine Phase I
NBP - Vaccine Phase I
HMP301 Asthma Botanical Phase III
SID123 Erectile dysfuction/premature ejaculation Chemical, combination drug Phase I
THVD201 Overactive Bladder Chemical, combination drug Phase III
SID125 Erectile dysfunction Orally dissolving film Registration
SKYCellflu SID132 Osteoarthritis Botanical Phase III
SID142 Chronic arterial occlusion Botanical / chemical Phase I
SID122 Parkinson’s disease Patch Screening
SID141 Pain Patch Screening
SID143 Stroke, systemic embolism BA enhancing tech Screening
SID144 Prostatic cancer Microsphere inj. Screening
CONTACT US
· Company SK Chemicals Co. Ltd.
Name : Justis TaeJun Cho · CEO Mahn-hoon, Park
General Manager · Specialty Specially chemicals and life science business
• Phone : +82-2-2008-2543 · Location 310, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-400 Korea
• E-Mail : [email protected] · Homepage www.skchemicals.com

41
Pharmaceutical

World Leader in API Custom Manufacture

ST Pharm Co., Ltd.

“ST Pharm provides reliable and timely custom manufacturing services for
API following stringent quality system and close communication with the
clients.”
Founded in 1983, ST Pharm (formerly known as Samchully Pharmaceutical) has been offering excellent custom
manufacturing service of APIs and their intermediates to meet clients’ high expectation for their use in
pharmaceutical development in compliance with cGMP requirements. Our reliability in service, which is well-
proven through decades of business relationship with many big pharmas and biotech clients, is the essence of our
strength along with our expertise in process development and scale-up optimization.

Main Products
1. Custom Manufacturing
1) New Drug APIs & Intermediates
2) GMP-Oligonucleotides (for RNA therapeutics)
2. Generic APIs & Intermediates
With highly experienced technical teams and synergistic collaboration with a parent company, Dong-A
Pharmaceutical, ST Pharm extends the product pipelines to generic APIs and intermediates with supportive DMFs
and high-spec quality control required to timely enter domestic and global market.
Products List (selected)
Category Products Customer Indication/Stage
HCV drug Originator (Worldwide) HCV/Phase 3
HIV drug Originator (Worldwide) HIV/Marketed
New Drug APIs
HIV drug Originator (Russia) HIV/Marketed
Oligonucleotide Originator (Worldwide) Oncology/Phase 2
Chiral epoxide Originator (Worldwide) HIV/Marketed
Pharmaceutical Chloro-(L)-sugar Originator (Worldwide) HBV/Marketed
Intermediates
Nucleoside monomers US/EP/JP Various RNA therapeutics/Clinical
Stavudine ROW/EU HIV/Marketed
Terizidone S.Africa/Germany/CIS Tuberculosis/Marketed
Generic APIs Atorvastatin Domestic/JP/ROW Hyperlipidemia/Marketed
Clopidogrel Domestic/ROW Anticoagulant/Marketed
Olmesartan JP/ROW Hypertension/Marketed

R&D Pipeline (selected)

Category Project Goal
Antibiotics Commercial in 2013
CMO Gastritis therapeutics for clinical trial
Diabetes therapeutics Commercial in 2014
Anticancer (CRPC) Pre-clinical in 2014
New Drug
HIV Pre-clinical in 2014
Anticancer Released in 2013
MRI contrast media Released in 2014
Generic APIs
HBV Released in 2015
CONTACT US COPD Released in 2016
Seong-Soo Oh
Chief Researcher · Company ST Pharm Co., Ltd.
R&D Planning Team · CEO Geun-Jho Lim
R&D center · Specialty CMO (New Drug APIs & Intermediates), Generic APIs, Oligo APIs and New Drug Development
• Phone : +82-31-488-1409 · Location 7F MSA Bldg., 891-43, Daechi-dong, Gangnam-gu, Seoul, Korea
• E-mail : [email protected] · Homepage http://www.stpharm.co.kr

42
 Pharmaceutical
Leading Biotech Company for Better Life
TAEJOON PHARM. CO., LTD.

Taejoon Pharm Co., Ltd. is a leading specialty pharmaceutical company in

ophthalmology, contrast media, and gastrointestinal agents with a global
presence in Europe, Africa, Asia Pacific Region and the United States of
America.
Main Products
Ophthalmic Solution
•CYPORIN N (API: CYCLOSPORINE, Nano-technology) – Released date: Feb 2015.
- Indication: Increase tear production in patients whose tear production is presumed to be suppressed due to
ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in
patients currently taking topical anti-inflammatory drugs or using punctual plugs.
Cyporin N
•MC FREE (API: SODIUM CARBOXYMETHYLCELLULOSE) – Released date: Sep 2011.
- Indication: For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure
to wind or sun. May be used as a protectant against further irritation.
•XALOST PLUS (API: LATANOPROST+TIMOLOL MALEATE) – Released date: Nov 2005.
- Indication: For the reduction of IOP in patients with open-angle glaucoma or ocular hypertension, who are
insufficiently responsive to the topical beta blocker.

Xalost Plus Contrast Media

•MRbester INJ. (API: GADOPENTETATE DIMEGLUMINE) – Released date: Oct 2004.
- Indication: MR imaging for the whole body excluding the heart, central nervous system including the brain,
spine and associated tissues in adults and pediatric patients (2 years of age and older).
•IOBRIX INJ. (API: IOHEXOL) – Released date: Jan 2002.
- Indication: Myelography, angiography, urography, contrast enhancement of computerized tomography.
•RADISENSE INJ. (API: IOPAMIDOL) – Released date: Jan 2002.
- Indication: For cerebral angiography and peripheral arteriography, contrast enhanced computed tomographic
imaging of the head and body, venography, and intravenous excretory urography.

GMP Certification List

No. GMP Facility Year
1 KGMP Sterile ophthalmic solution 1995, 2010, 2011, 2012, 2014
2 EU GMP Sterile ophthalmic solution 2008, 2011, 2014
3 Anvisa GMP Sterile ophthalmic solution 2010
4 Actavis Audit Vendor audit for sterile ophthalmic solution 2010
5 NAFDAC GMP Sterile ophthalmic solution 2011

R&D Pipeline
Product Name Indications Current Status
Age-related Macular Degeneration (New Biological Entity) AMD Phase 2/3
Antibiotic product (New Chemical Entity) Bacterial conjunctivitis Pre-clinical
Dry eye product (New Chemical Entity) Dry eye Pre-clinical
Combination or Improved drugs Ophthalmic/GI indications Phase 3 ~ Pre-clinical

CONTACT US · Company TAEJOON PHARM. CO., LTD.

· Co-CEO Tae Young Lee / Joon Youb Lee
Jun Hee Lee / Head of Department · Specialty Ophthalmic solution, Contrast media, Gastrointestinal agents
• Phone: +82-2-799-0072 · Location 8 Daesagwan-ro 31-gil, Yongsan-gu, Seoul, Korea
• E-mail: [email protected] · Homepage www.taejoon.co.kr

43
Pharmaceutical

Leading Biotechnology Company Targeting Cardiovascular Disease,

Neuropathy, Cancer and Immune-related Disorder.
ViroMed Co., Ltd.

ViroMed Co., Ltd. (ViroMed), a leading biopharmaceutical company focusing on the development of innovative
drugs, was established in 1996 and is headquartered in Seoul, Korea with a US presence in Atlanta. ViroMed has
assembled a diverse, but technologically and conceptually linked, pipeline of new and innovative therapeutics in
the areas of cardiovascular and neurological diseases, cancers, and immune disorders, with 9 projects in clinical
stages in the US, Korea, and China. Recently, ViroMed has successfully completed a phase II clinical study for
diabetic peripheral neuropathy and critical limb ischemia (an extreme form of peripheral artery disease: PAD) in the
US and Korea with a phase I/II clinical study for amyotrophic lateral sclerosis ongoing in the US. In China, a phase
III clinical trial is underway for chemotherapy-induced thrombocytopenia. ViroMed is also running a botanical
therapeutics program as a cash cow to balance the long-term biologics programs.

Representative Product – Biologics (Clinical trial)

Product Target Disease Technology Country Development Stage
USA Phase II (Completed)
VM202-PAD Peripheral Artery Disease DNA Korea
China Phase III (Planned)
USA Phase II (Completed)
VM202-DPN Diabetic Peripheral Neuropathy DNA
Korea Phase III (Planned)
VM202-ALS Amyotrophic Lateral Sclerosis DNA US Phase I/II (Ongoing)
DNA + Phase I (Completed)
VM202-CAD Coronary Artery Disease Korea
Injection Catheter Phase II (Planned)
VM501 Thrombocytopenia Protein China Phase III (Ongoing)
Phase I (Completed)
VM206 Breast Cancer DNA+Virus Korea
Phase II (Planned)

VM202 – New and Innovative Drug for Cardiovascular and Neurological Diseases
VM202 is a DNA-based medicine designed to express two isoforms of the protein called hepatocyte growth factor (HGF). HGF
is well known to induce the formation of new blood vessels and the growth and regeneration of nerve cells. Currently,
VM202 is in clinical trials for 4 major cardiovascular or neurological diseases. In all studies, VM202 is delivered by
a simple intramuscular injection around the affected site. 1 A double blind, placebo controlled, phase II study for critical
limb ischemia (VM202-PAD) has been very successfully completed in the US and Korea, demonstrating that VM202 could
increase blood flow and tissue perfusion, thereby effectively treating ischemia. 2 Another double blind, placebo controlled,
phase II study for diabetic peripheral neuropathy (VM202-DPN) in the US and Korea has been completed last year,
showing high pain reliving effect and potential to expand current market. The data was recently published in an international
scientific journal. 3 After successful phase I trial for coronary artery disease (VM202-CAD), a phase II study is planned for
2015 in Korea. 4 VM202 has also been approved for a phase I/II trial for amyotrophic lateral sclerosis (VM202-ALS), also
known as Lou Gerig’s disease, and is currently ongoing in the US.
VM206 – Therapeutic Cancer Vaccine
VM206 is a therapeutic cancer vaccine delivered through a simple intramuscular injection that induces an immune
response against the tumor-associated antigen Her2/neu, found in several types of cancers such as breast cancer. A
phase I clinical study for breast cancer has been successfully completed in Korea, showing that injecting VM206 could
effectively induce both humoral (antibody) and cellular (CTL) immune responses against cancers. The product is being
developed for patients who have received surgery and/or chemotherapy. A phase II trial is planned for Korea.
VM501 – Recombinant Protein for Chemotherapy-Induced Thrombocytopenia (CIT)
The only drug approved for CIT by the US FDA is a recombinant interleukin 11 (IL-11) protein called Neumega. Its use
has been highly limited because of serious side effects associated with this drug. VM501 is a genetically engineered
interleukin 11 (IL-11) designed to produce a high level of efficacy, but with improved safety. After successful phase I and
II studies, a phase III clinical study is currently ongoing in China.

Contact Information · Company ViroMed Co., Ltd.

· CEO Kim Yongsoo
Youngtae Hong · Specialty 1) DNA/protein-based biopharmaceuticals
Section Chief, Business 2) Phytotherapeutics (botanical drugs/nutraceuticals)
Strategic Business Development · Head Office 5th Bldg 203, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, Korea
• E-mail : [email protected] · Homepage www.viromed21.com

44
 Pharmaceutical
Best Partner Best Yuhan
Yuhan Corporation

Equipped with the state-of-the-art cGMP manufacturing facilities and

extensive research capabilities, Yuhan is growing into a global pharmaceutical
company offering one stop services from R&D to commercial production
of intermediates, APIs, and finished products.
Yuhan has undergone successful audits by many international regulatory agencies such as the US FDA, the
EU EMA/EDQM, the Australian TGA, and the Japanese PMDA. Yuhan’s overseas’ business activities include:
- New drug development projects with multinational partners.
- Developing and optimizing cost effective synthetic processes for APIs and intermediates.
Yuhan is committed to deliver the best medicines to the world for improving the health and quality of human life.
Beginning with the out-licensing to China of Yuhan’s ‘Revanex’, the world’s first acid pump agonist, Revanex is now
supplied world-wide to markets in India and Southeast Asia. Yuhan is continuously expanding its overseas markets
with finished products.

Products
Product/Project Indication Feature & Strength
Revanex Gastritis NCE drug, NDA (2007), World-first acid pump antagonist (APA)
NCE drug, on phase 2, 2nd generation APA. Fast onset-time and cleaner adverse
YH4808 GERD effect profile than current PPI
NCE drug, expected to fulfill unmet medical needs for IBS treatment, Comparative
YH12852 IBS advantage of efficacy and safety to current market players

R&D Pipeline

CONTACT US
Head Quarters · Company Yuhan Corporation
74 Noryangjinro Dongjak-gu, Seoul, · CEO Jung hee, Lee
156-754, Korea · Specialty Pharmaceutical
• Phone : +82-2-828-0181 · Location 74 Noryangjinro Dongjak-gu, Seoul
• Fax : +82-2-828-0300 · Homepage http://www.yuhan.co.kr/Eng/index.asp

45
Supplement
1. Products Expected to Export
2. Technology Transfer
3. Certifications from Health Authorities
 1. Products Expected to Export
Company Product name Active Ingredient Indication Category Expected Note
country
Supplement

entered
Middle East into license
Dried ivy leaf ext. Relief of cough and sputum due to acute Asia / Africa agreement
Synatura syrup + Coptis rhizome respiratory infection, chronic inflammatory Respiratory / South East in America,
butanol dried ext. bronchitis system drugs Asia Mexico,
/ L. America Iran and EU
including
CIS.
Middle East entered
Anycough Relief of cough symptoms caused by rhinitis, Respiratory Asia / Africa into license
capsule Theobromine sinusitis, nasopharyngitis and acute & system drugs / South East agreement
chronic bronchitis Asia in EU and L.
America.
Ahngook Digestive
pharm. Letopra tablet S-Pantoprazole Treatment of reflux esophagitis (GERD) system drugs Global
co.Ltd
Global entered
Anytin SR tablet trimebutine maleate irritable bowel syndrome, functional Digestive Except into license
S.R dyspepsia, gastroduodenitis system drugs China agreement
in China.
entered
prevention and continuous therapy of into license
Curost granules montelukast sodium asthma, relief of perennial and seasonal Respiratory Global agreement
allergy rhinitis system drugs in Vietnam
and
Philippines.
dried ivy leaf 30% Relief of cough and sputum due to acute Respiratory
Icopang syrup ethanol ext. respiratory infection, chronic inflammatory system drugs Global
bronchitis
Mepem Inj. 1g Meropenem 1g Antibiotics Prescription -
Medicine
Sinraci Inj. 500mg Imipenem, Antibiotics Prescription -
Cilastatin sodium Medicine
BCWORLD Prescription US, EU,
PHARM. Vitamin Inj. Tamiflumate Well-being products Medicine -
CO., LTD. Middle East
Morphine Sulfate Morphine Sulfate Narcotics Prescription -
Inj. Medicine
BC Atorvastatin Tab. Atorvastatin Calcium Lipid-Lowering agents Medicine -
Remiba Inj. Remifentanyl HCl Narcotics Medicine -
SAMiRNATM- Synthetic drugs Solid cancer siRNA drug US, EU
Survivin
SAMiRNATM-IPF/ IPF(Idiopathic Pulmonary Fibrosis)/
BIONEER COPD Synthetic drugs COPD(chronic obstructive pulmonary disease) siRNA drug US, EU, CN
CORPORATION target genes
US, EU,
SAMiRNATM-DN Synthetic drugs Dengue fever/ siRNA drug East South
Dengue hemorrhagic fever Asia, South
America
Kanarb Fimasartan Hypertension Prescription Global
Medicine
Kanarb Fimasartan with HCTZ Hypertension Prescription Global
Combination or CCB Medicine
ADmycin Doxorubicin Antineoplastics Prescription Global
Medicine
Boryung Prescription
Pharm­ Oxalitin Oxaliplatin Antineoplastics Medicine Global
aceutical
co.,Ltd. Colloidal Aluminum Non-
Gelfos Phospate Gastric Hyperacidity Heartburn Prescription Global
Medicine
Stogar Lafutidine Gastric ulcer Prescription Global
Medicine
Cinalong Cilnidipine Essential Hypertension Prescription Global
Medicine
TacroBell Tacrolimus Immunosuppressant Prescription Worldwide
Medicine
Duvie Lobeglitazone Anti-diabetics Prescription Worldwide
Chong Medicine
Kun Dang Prescription
pharm­ Leukivec Imatinib Anti-cancer Medicine Worldwide
aceutical
Corp. Gemtan Gemcitabine Anti-cancer Prescription Worldwide
Medicine
Belotaxel Docetaxel Anti-cancer Prescription Worldwide
Medicine

48
Company Product name Active Ingredient Indication Category Expected Note
country
Moveloxin Inj. Moxifloxacin Infection Antibiotics

Supplement
Cinezolid Tab&Inj. Linezolid Infection Antibiotics
Citopcin Inj. Ciprofloxacin Infection Antibiotics
Tapocin Inj. Teicoplanin Infection Antibiotics
Vancorin Inj. Vancomycin Infection Antibiotics
Epokine Inj. Erythropoietin Anemia Biologicals
Leukokine Inj. Filgrastim Neutropenia Biologicals
CJ Pemta Inj. Pemetrexed Cancer Oncology
HealthCare
corporation Calmtop Inj. Irinotecan Cancer Oncology
Soybean oil IV Solution Generic
OmapOne Lipid Inj. Olive oil, Fish oil Parenteral Nutrition (1-chamber of Smof
Medium-Chain bag) Lipid®
Triglycerides
IV Solution Generic
OmapOne Lipid, Amino acid, Total Parenteral Nutrition (TPN) (3-chamber of Smof
Peripheral Inj. Glucose bag) Kabiven
Peri®
Enteone Tab. Entecavir Hepatitis B infection Antiviral
Respiratory distress caused by airway
Resnalin patch Tulobuterol obstruction of bronchial asthma, Prescription US, EU, etc. -
acute bronchitis, chronic bronchitis, or Medicine
emphysema
Aceren cap. Diacerein Rheumatoid arthritis, osteoarthritis Prescription US, EU, etc. -
Medicine
Dae Hwa Urticaria, hay fever, allergic rhinitis,
Pharm- Betamethasone, drug hypersensitivity reaction, chronic Prescription
aceutical Almetamine tab. Dexchlorpheniramine bronchial asthma, atopic dermatitis, Medicine US, EU, etc. -
Co. Ltd. maleate eczema, contact dermatitis, allergic
conjunctivitis
Biphenyl dimethyl Chronic persistent and active hepatitis Prescription
Bidica tab. dicarboxylate that is associated with a high SGPT level or Medicine US, EU, etc. -
drug-induced high transaminase level
Bromelain, Fracture, sprain, internal, external and
Protase tab. Crystallized Trypsin incarcerated hemorrhoid after proctoptosis OTC Product US, EU, etc. -
and a hemorrhoidal surgery
Freefol MCT Inj. Propofol 1%, 2% General Anesthesia Narcotic Paraguay,
Venezuela
Wontran ER Tab. Acetaminophen + Chronic and Acute pain Analgesic Guatemala
Tramadol HCl
Daewon
Pharm. Co., Pelubi Tab. Pelubiprofen Osteoarthritis, Rheumatoid, Lumbargo Analgesic Thailand
Ltd. Megex-I Susp. Megestrol Acetate Anorexia Sex hormone Jordan
Oramin F Soft Cap. Multivitamin + Korean Supplement of vitamins and minerals Multivitamin Kuwait
Ginseng
Nezelex Spr. Mometasone Furoate Allergic rhinitis Respiratory Russia
Easyef Spray EGF Diabetic foot ulcer, oral mucositis, wounds biologics worldwide
Easyef Ointment EGF Acute wound biologics worldwide
Caretropin 22.5 IU hGH Growth hormone deficiency biologics worldwide
Eposis EPO Anemia in end stage renal disease biologics worldwide
Novosis BMP-2 Dental sinus lift graft biologics worldwide
Novosis – OS BMP-2 spinal fusion biologics worldwide
Nabota Botulinum toxin type A glabellar lines, upper limp spasticity biologics worldwide
Olmesartan + Value-added
Daewoong Olostar Rosuvastatin Concomitant hypertension and dyslipidemia Generics & worldwide
Pharm­ Generics
aceutical. Value-added
Co. LTD URSA Ursodeoxycholic acid Liver & bile disease including cholestasis, Generics & worldwide
Gallstone etc Generics
Ranitidine + Bismuth Value-added
Albis + Sucralfate Gastric & duodenal ulcer, gastritis Generics & worldwide
Generics
Relif of painful symptoms associated with Value-added
Dehecta Dioctahedral smectite esophageal-gastric and large intestinal Generics & worldwide
diseases, Acute/Chronic diarrhea Generics
Prostate cancer, Endometriosis, Precocious Value-added
Luphere Leuprolide puberty Generics & worldwide
Generics

49
 Company Product name Active Ingredient Indication Category Expected Note
country
Value-added
Supplement

Neovest Iopromide CT contrast media Generics & worldwide

Generics
Value-added
Daewoong Nurigra Sildenafil Erectile Dysfunction Generics & worldwide
Pharm­ Generics
aceutical.
Co. LTD Value-added
Nurigra Chew Sildenafil Erectile Dysfunction Generics & worldwide
Generics
Mediclore poloxamer, gelatin, medical device - adhesion barrier medical device worldwide
chitosan
GemVax & Tertomotide USA, China,
KAEL Co., RIAVAX®inj. hydrochloride pancreatic cancer Japan
Ltd.
USA, Europe, Ongoing
Beroctocog alfa For the prevention and control of bleeding Biological Latin America, Ph. III in
GreenGene F inj. (Blood coagulation episodes and preoperative management in Product Asia, US &
factor VIII, recombinant) Hemophilia A Middle East, Europe
etc
Purified Inactivated
Influenza Virus Antigen
Type A (H1N1) USA, PQ from
Green Purified Inactivated Biological Latin America, WHO &
Cross GCFLU inj. Influenza Virus Antigen For the Prophylaxis against Influenza Product Asia, Procured
Corp. Type A (H3N2) Middle East, through
Purified Inactivated etc PAHO
Influenza Virus Antigen
Type B
USA, Europe, Orphan
For patients with Hunter Syndrome Biological Latin America, Drug
Hunterase Idursulfase-ß (Mucopolysaccharidosis II, MPS II) Product Asia, Designation
as an enzyme replacement therapy Middle East, granted
etc from US FDA
Ketotop plaster Ketoprofen NSAID Small Molecule Global
Ketotop gel Ketoprofen NSAID Small Molecule Global
Seaweed
Calcium for Bone powder,Magnesium Bone & joint health management, Health Functional Global
oxide,Vitamin D3 osteoporosis Food
mixture
11 kinds of Vitamine,3 Health Functional
TripleCare kinds of Mineral, Circulation, Vitality Food Global
Omega-3
Saw palmetto Health Functional
Sawpalmax naturalextract, Prostate Food Global
Octacosanol
Eye-Omega3 Fish oil, Vitamin A, E Circulation & Eye health management Health Functional Global
Food
MSM Jointcare Dimethyl sulfonate Multicare for Joint & Cartilage healthcare, Health Functional Global
Osteoporosis management Food
Hutos Joa Zinc, Aloe, Chlorella Immunity for Kids Health Functional Global
TeunTeun andother mineral Food
Health Functional
Handok Inc. Hutos Ara ssukssuk Chewable Omega 3 Circulation forkids Food Global
Hutos Nado Calcium, Calcium supplement for kids Health Functional Global
ssukssuk MagnesiumVitamine D Food
Hutos Moya beta-Carontin, Eye healthcare management for kids Health Functional Global
banjjak Chewable Food
Hutos Multivitamin Multi-vitamine(13 Health Functional
& Mineral kinds ofVitamin, 6 Basic nutrition sate for kids Food Global
kinds of mineral)
Aquainnerskin Hyaluronic acide Skin Care Health Functional Global
Food
Body styling Garcinia Cambogia Body Shape Health Functional Global
Food
Probio Double Probiotics, Vitamine C Intestine Health Functional Global
Action Food
Good for Liver, Milk thistle Health Functional
Milk-thistle Care Q (silymarin),Tumeric Liver + Vitality Food Global
extract(Curcumin)
Full of Neutrient, 13 kinds of Health Functional
Vitafood Q Vitamine,8 kinds of Multi-vitamin Food Global
Mineral,Curcumin

50
Company Product name Active Ingredient Indication Category Expected Note
country
Good for Circulation, Health Functional

Supplement
Omega Q Omega-3, Curcumin Circulation, Improve triglyceride in blood Food Global

Handok Inc. Ready Q Drink curcumin 50mgMango Hangover management General Food Global
flavor fruit drink
Ready Q Chew curcumin Hangover management General Food Global
30mg,Chewable jelly
DAGES CAP Pepsin etc. Polyenzymatic digestant OTC Product China
Cardiovascular Prescription Vietnam,
TROPIN inj. Dopamine HCI related agents Medicine Venezuela
etc.
POSOD EYE DROPS Potassium iodide, Anticataratics Prescription Nigeria,
Sodium iodide Medicine Vietnam etc.
HANLIM
PHARM. NASAFLEX Mometasone Prescription
CO., LTD. NASAL SPRAY furoate, Antiallergics Medicine None
Azelastine HCl
RISENEXPLUS TAB Risedronate, Treatment of osteoporosis Prescription None
Cholecalciferol conc. Medicine
PROTAN Prescription Nigerial,
EYE DROPS Latanoprost Antiglaucoma Medicine Cambodia
etc.
Amosartan Amlodipine + Losartan Hypertension FDC Brazil, CIS
Amosartan Plus Amlodipine + Losartan Hypertension FDC WW
+ Clorthalidone
Amorsartan Q Amlodipine + Losartan Hypertension FDC WW
Hanmi + Rosuvastatin
Pharm. Tadalopine Amlodipine + Tadalafil Hypertension / ED FDC WW
Rosutib Rosuvastatin + Dyslipidemia FDC WW
Ezetimibe
Esomezol Esomeprazole GERD IMD WW
Strontium
EU, Oceania,
Clacier Eye drop Cyclosporin 0.05% Dry eye syndrome Prescription North Modified
Drug America, Generic
Middle-East
Valsarex Tablet Amlodipine 5mg Essential Hypertension Prescription EU BE study
Valsartan 80mg Drug
South-East
Lercapin Tablet Lercanidipine HCL Lercanidipine HCL 10mg Prescription Asia -
10mg Drug Southwest
HUONS Asia
CO., LTD.
Mucoramin Tablet Rebamipide 100mg Gastric ulcer, acute gastritis, Prescription South-East -
acute aggravation of chronic acute Drug Asia
Norepinephrine Prescription Africa
Noreprin injection bitartrate 8mg Myocardial infarction, Shock by sepsis Drug South-East -
Asia
Heparin Latin
Pine injection sodium25,000IU/ Anticoagulant Prescription America, -
25000IU 5mL Drug Northeast
Asia
Surfolase acebrophylline Cough : acute and chronic bronchitis Respiratory Worldwide -
(Cap)
Levotuss levodropropizine Cough : acute and chronic bronchitis Respiratory Worldwide -
Hyundai (Tab, SYR)
Pharm- Uremin desmopressin acetate Nocturnal enuresis Urogenital Worldwide -
aceutical (Tab) system
Co., Ltd. Drovan Prevention of osteoporosis in Musculo-
(Tab) ibandronate sodium postmenopausal women Skeletal system Worldwide -
Nebolmin nebivolol Hypertension, Chronic heart failure Cardiovascular Worldwide -
(Tab)
2nd line of CML(chronic myeloid leukemia)- prescription Asia,
SUPECT Cap. radotinib CP(chronic phase) medicine EU and Lantin -
America
Gastric Ulcer, Deodenal Ulcer, prescription Asia,
IL-YANG Noltec tab Ilaprazole Erosive Esophagitis medicine EU and Lantin -
PHARM- America
ACEUTICAL ILYang Flu Vaccine Trivalent purified
CO., LTD. Pre-filled inactivated Influenza Influenza Vaccine Vaccine Any -
Syringe inj virus antigen
Sol + LIQUID Taurine, Multi Vitamin Improves performance Beverage/ Any -
Energy Drink
WONBI-D LIQUID Korea Ginseng Improves Health OTC Product Any -

51
 Company Product name Active Ingredient Indication Category Expected Note
country
Middle East
Supplement

Clotinab Abxicimab Anti-thrombotic orphan drug South East

Asia

ISU Abxis Middle East

Abcertin Imiglucerase Gaucher's disease orphan drug South East
Asia

Fabagal Agalsidase beta Fabry's disease orphan drug Latin

America
Imipenem
Carbapenem Meropenem Antibiotics API Global
Doripenem
Ertapenem

Prepenem Inj. Imipenem Antibiotics Sterile Global

injectable

Pospenem Inj. Meropenem Antibiotics Sterile Global

JW injectable
Pharm­
aceutical CombiFlex Lipid Inj. Glucose, Amino acid, Total Parenteral Nutrition I.V. solution Global
And Lipid

Linezolid Inj. Linezolid MRSA Premix Global

I.V. solution

Levofloxacin Inj. Levofloxacin Antibiotics Premix Global

I.V. solution
Hitraconazole Itraconazole Fungal Infection Tablet Global

Prescription EU
ZERO-X Cap. Orlistat Anti-obesity Agents Medicine South America -
Asia

Prescription EU
GLITOL Tab. Miglitol Anti-Diabetics Medicine Asia -
Middle East
Kolmar Valsartan and Prescription EU
Korea MAXFORGE Tab. Amlodipine Antihypertensive Medicine Asia -
Co., Ltd. Middle Eas

Prescription Asia
Taminal Cap. Tamsulosin BPH Medicine Middle East -
Africa

Tacrolimus Tacrolimus Ointment Prescription Asia

Ointment 0.1%, 0.03% Atopy Medicine Middle East -
Africa

Prescription Controlled
Clanza®CR Tab Aceclofenac 200mg [M01A]Pain caused by rheumatism Medicine Global Release
Formulation

Prescription Controlled
Korea Cilostan®CR Tab Cilostazol 200mg [B01C]Ischemic symptoms, Thrombosis Global Release
United Medicine Formulation
Pharm. Inc.
Clavixin®Duo Tab Clopidogrel 75mg and [B01C]Acute coronary syndrome (antiplatelet) Prescription Global Fixed Dose
Aspirin 100mg Medicine Combination

Kalomin®Tab Pelargonium sidoides [R05C]Upper respiratory tract infections Prescription Global New Dosage
ext. Medicine Formulation
Vancomycin for inj. Vancomycin Antibiotics Prescription worldwide
500/1000 mg Medicine
Teicoplanin for Inj. Teicoplanin Antibiotics Prescription worldwide
200/400 mg Medicine
Kuhnil Omega-3/ Omega-3 + Prescription
Pharm­ Rosuvastatin mini Rosuvastatin Cardiovascular system drugs Medicine worldwide
aceutical capsule 2000/5mg
Co.,Ltd
Omega-3/ Omega-3 + Prescription
Atorvastatin mini Atorvastatin Cardiovascular system drugs Medicine worldwide
capsule 2000/10mg
Pulmican respules Budesonide Drug for bronchial asthma Prescription worldwide
500μg Medicine

Biological MENA,
EPO Erythropoetin Anemia in chronic renal disease product Brazil, -
Russia
LG Life Biological MENA,
Sciences, rFSH recombinant FSH Infertility product Mexico, Brazil -
Ltd.
Biological Mexico,
hGH human Somatropin Growth hormone deficiency product Russia, -
Southeast Asia

52
Company Product name Active Ingredient Indication Category Expected Note
country
MENA,

Supplement
Hyruan plus/SIHA Hyaluronic acid Joint arthritis Medical device Southeast -
Asia,
LG Life Eastern Europe
Sciences,
Ltd. MENA,
Yvoire Hyaluronic acid Wrinkle correction Medical device Southeast -
Asia,
Eastern Europe
Blepharospasm, Focal Biological
Neuronox® Botulinum toxin spasticity in pediatric Product ROW, etc.
Medytox type A cerebral palsy, (Prescription
Inc. Glabellar Wrinkles medicine)
Neuramis® Hyaluronic acid wrinkles Medical US, EU,
Device etc.
PLATLESS Tablet Clopidogrel bisulfate Antithrombotic Prescription Worldwide -
Medicine
BAMEDIN Tablet Rebamipide Treatment of gastroduodenal ulcers Prescription Worldwide -
and gastritis Medicine
NEUSTATIN-A Atorvastatin Calcium Antihyperlipidemia Prescription Worldwide -
Tablet Medicine
AIDBONE PLUS D Alendronate sodium + Treatment of Osteoporosis Prescription Worldwide -
Tablet Cholecalciferol Medicine
Samjin Active
Pharm- Clopidogrel APIs Antithrombotic Pharmaceutical Worldwide -
aceutical bisulfate (form 1) Ingredients
Co., Ltd.
Rosuvastatin Active
Calcium APIs HMG-CoA reductase inhibitor Pharmaceutical Worldwide -
Ingredients
Pitavastatin Active
Calcium APIs HMG-CoA reductase inhibitor Pharmaceutical Worldwide -
Ingredients
Olmesartan Active
medoxomil APIs Angiotensin II blocker Pharmaceutical Worldwide -
Ingredients
Russia, Cremophor
Genexol® PM Paclitaxel Anti-cancer Prescription CSI, Africa, free
Medicine South- formulation
America, etc.
Prescription Tween-80
Nanoxel® M Docetaxel Anti-cancer Medicine Worldwide free
formulation
Samyang
Biopharm- Oncology Paclitaxel Prescription
aceuticals Injectables Docetaxel Anti-cancer Medicine Worldwide Generic
Corporation Oxaliplatin
Zolenic® Injection Zoledronic acid Anti-cancer Prescription Worldwide Generic
Medicine
DemenCure® Patch Rivastigmine Dementia Prescription Worldwide Lower API
Medicine & same PK
Fentaderm® Fentanyl Severe pain Prescription Worldwide Lower API
Patch Medicine & same PK
Hyal Inj. Sodium hyaluronate Osteoarthritis Prescription world wide
Medicine
Hyal Forte Inj. Sodium hyaluronate Osteoarthritis Prescription world wide
Medicine
Shin Poong Prescription
Pharm. Varodipine Tab. Amlodipine besylate Anti-hypertension Medicine world wide
Co.,Ltd
Hivix Tab. Clopidogrel bisulfate Anti-thrombotic Prescription world wide
Medicine
Lozarsin Tab. Losartan potassium Anti-hypertension Prescription world wide
Medicine
EU, US, Already
Rivastigmine patch Rivastigmine Alzheimer’s disease Prescription Asia, Latine exporting
medicine America, to EU
Middle east
SK Prescription Asia, Middle Exporting
Chemicals Albumin Human albumin Hypo-albuminemia medicine east, Latine to India,
Co. Ltd. (Blood product) America China etc
Prescription Asia, Middle Exporting
Liv-Gamma Human immunoglobulin Agammaglobulinemia medicine east, Latine to India,
(SN) (Blood product) America Thailand,
etc

53
 Company Product name Active Ingredient Indication Category Expected Note
country
Prescription Asia, Middle NDA
Supplement

Hepabulin IV Human anti-hepatitis B post-exposure prophylaxis HBV exposure medicine east, Latine submitted
immunoglobulin (Blood product) America in Korea
Exporting
Trast Piroxicam Osteoarthritis, Tenosynovitis, Myalgia & OTC product Asia, Latine to some
others America Asian
SK countries
Chemicals Clematis mandshurica Prescription Asia, Latine
Co. Ltd. Joins & others Osteoarthritis medicine America
Mvix Mirodenafil Erectile dysfunction Prescription Asia, Latine
medicine America
Prescription Asia, Middle
Tadalafil ODF Tadalafil Erectile dysfunction medicine east, Latine
(ODF) America
Prescription Asia, Middle Approved
Montelukast ODF Montelukast Asthma medicine east, Latine in Korea
SK (ODF) America
Chemicals
Co. Ltd.
SKYCellflu Influenza vaccine Prevention for influenza virus (Cell culture) Vaccine Asia, Latine Preparation
America etc. for PQ
WHO

API Montelukast Asthma API US, EU etc. -

API Stavudine anti HIV/AIDS API US, EU etc. -
ST Pharm API Terizidone anti Tuberculosis API US, EU etc. -
Co., Ltd.
API Clopidogrel Bisulfate Anti-coagulant API US, EU etc. -
API Atovastatin Calcium Metabolic disease API US, EU etc. -
Anhydrous
Cyporin N Cyclosporine Dry eye Prescription EU,US,Asia
medicine
MC Free Sodium CMC Dry eye Prescription EU,US,Asia
medicine
Hyaluni Hyaluronic acid Dry eyes for the temporary relief of burning, Prescription EU,US,Asia
irritation and discomfort medicine
TJ Ultra Polyethylene Glycol Temporary relief of irritation and burning due Prescription EU,US,Asia
to dryness of the eye medicine
Xalost Plus Latanoprost plus Timo- Anti-glaucoma Prescription US
TAEJOON lol maleate medicine
PHARM.
CO., LTD. Xalost Latanoprost Anti-glaucoma Prescription US
medicine
Alpadine Olopatadine HCl Conjunctivitis Prescription EU,US,Asia
medicine
Iobrix Iohexol Angiography Prescription EU,US,Asia
medicine
Coolprep Polyethylen Glycol Bowel cleansing for x-ray and endoscopic Prescription EU,US,Asia
examination medicine
Lamina G Sodium Alginate Gastric & duodenal ulcer, erosive gastritis Prescription EU,US,Asia
medicine
Duowell Tablet Telmisartan + Treatment for htypertension and
Rosuvastatin hyperlipidemia
Newfactam Bovine Lung Surfactant Treatment for respiratory distress syndrome
of newborns
Almagate Almagate Antiacidic functions
Suspension
Yuhan
Corporation Antiphlamine S Methyl Salicylate Anti-inflammatory agent
Lotion L-menthol
Yucla Tablet Amoxicillin + Antibiotics
Clavulanate Potassium
3-Chamber TNA Glucose+Amino
(Total Nutrient acid+Lipid Supply of nutrition
Admixture)

54
2. Technology Transfer
Development Status Targeted
Company Category Indication Note

Supplement
Korea Overseas country
Sustained release Urology Completed Global
Ahngook
pharm. Neutropenia Research Global
co.Ltd Bio-better
Growth Hormone Deficiency Research Global
Biologic Cancer Preclinical - US / EU -
BCWORLD Biologic Cancer Preclinical - US / EU -
PHARM.
CO., LTD. small molecule hyperlipidemia Preclinical - US / EU -
small molecule Schizophrenia Preclinical - US / EU -
Boryung
Pharm­ New Chemical Entity Hypertension Launching Launching Global
aceutical (ARB: Fimasartan)
co.,Ltd.
Bukwang Small Molecule Cancer Phase 1/2a Phase 1/2a EU, Japan -
Pharmaceutical
Co., Ltd. Nucleoside Hepatitis B virus Launched Launched NDA South America, EU -
Small molecule Cancer Launched China, Taiwan,
Camtobell Macau
Small molecule Diabetes Launched Worldwide
Duvie
Chong Kun Small molecule Cancer phase 1 Worldwide
Dang pharm­ CKD-516 (completed)
aceutical Small molecule
Corp. CKD-581 Cancer phase 1 Worldwide

biosimilar Anemia Phase 3 Worldwide

CKD-11101 (sanctioned)
vaccine HPV vaccine phase 1 China
CKD-12201 (completed)

Phase 2 Phase 1 China,

CJ-12420 GERD (Completed) (Completed) South-East NCE
Asia

VogMet® China,
(voglibose+metformin) Diabetes Launched N/A South-East IMD
CJ Asia
HealthCare Pemta® RTU Launched in 4Q EU, Japan, RTU(ready-to-
corporation (pemetrexed) Oncology 2015 N/A China use) liquid
CJ-30056 Hyperlipidemia & Diabetes Phase II N/A EU, USA, China IMD
(atorvastatin+metformin
CJ-30059 Hypertension Phase III N/A EU, USA, China IMD
(candesartan+amlodipine
Phase IIa
Small molecule Osteoarthritis Approved completed Worldwide
(EU)
Crystal­ ABSSSI, Osteomyelitis Phase IIa
Genomics, Small molecule and other serious Staph - completed Worldwide
Inc. infections including MRSA (USA)

Small molecule Cancer Phase Ib/ - Worldwide

2 ready
Small molecule Cancer (hematologic) Preclinical Worldwide
Mucous membrane adsorptive US
composition which enables poorly Cancer Phase 3 - EU -
soluble compounds to solubilize. etc.

Manufacturing method of solubilize US

composition of paclitaxel Cancer Phase 3 - EU -
etc.
Dae Hwa US
Pharm- Percutaneous absorption product Analgesic Phase 3 - EU -
aceutical including diclofenac etc.
Co. Ltd.
US
Manufacturing method of voglibose Diabetes Launching - EU -
etc.

Composition of percutaneous US
absorption including Tulobuterol Respiratory Launching - EU -
etc.
Daewon Osteoarthritis, Rheumatoid,
Pharm. Co., Analgesic Lumbargo O China
Ltd.

55
 Development Status Targeted
Company Category Indication country Note
Korea Overseas
Supplement

biologics Diabetic foot ulcer, oral launched launched worldwide

Daewoong mucositis, acute wounds
Pharm­ Anemia in end stage renal
aceutical. biologics disease launched launched worldwide
Co. LTD
biologics Growth hormone deficiency launched launched worldwide
Gene & Stem Cell HPV Cervical Cancer Phase 2 Phase 2
Hemophilia Preclinical Preclinical
Autoimmune diseases Preclinical Preclinical
Genexine, Growth Hormone Phase 2 Phase 2
Inc. Hybrid Fc Technology
Type 2 Diabetes Preclinical Preclinical
Anemia Phase 2 -
Neutropenia Phase 1 -
Small Molecule Glaucoma Discovery - Global
Handok Inc. Biological Product Growth Hormone Deficiency Phase II Phase II Global
Biological Product Auto-inflammatory disorders Phase I - Global

Small molecule Age related Macular Preclnical USA, EU

Degeneration
USA, EU, East
IMD Osteoarthritis Phase 2 Asia, South
America
HANLIM USA, EU, East
PHARM. IMD Hypertension Phase 1 Asia, South
CO., LTD. America
Japan, EU, East
IMD Perennial allergic rhinitis Approval Asia, South
America

Herbal Bronchitis Phase 2 Japan, EU, East

Asia

Diabetes/Obesity Phase II US/EU WW

Phase II
Metabolic Diabetes Pre-Clinical EU Phase I WW
Diseases
Diabetes Pre-Clinical Pre-Clinical WW
Diabetes/Obesity Pre-Clinical EU Phase I WW

Endocrine Diseases Growth Hormone Deficiency Phase II EU Phase II WW

in adults

Neutropenia Phase I US/EU WW

Phase II
Hanmi
Pharm. Gastric Cancer Phase II - WW
Colorectal Cancer Phase I - WW

Oncology NSCLC, Gastric Cancer, Phase II - WW

Breast Cancer
NSCLC Phase II - WW
Solid Tumor Phase I - WW
Gastric Cancer, Breast Phase I - WW
Cancer
Autoimmune Rheumatoid Arthritis - EU Phase I WW

Gastroesophageal reflux Development Simplification of

Prescription Drug disease completion/ - America Manufacturing
Under BE study process
HUONS Under Simplification of
CO., LTD. Prescription Drug Essential Hypertension development - EU Manufacturing
process

Prescription Drug Hypotensive agent Development - CIS, EU IMD

completion
Hyundai CNS Epilepsy PC - Worldwide -
Pharm-
aceutical GI Protective agent of the PC - Worldwide -
Co., Ltd. gastric mucous membrane
IL-YANG 2nd line of CML(chronic
PHARM- prescription medicine myeloid leukemia)-CP Launching - Any -
ACEUTICAL (chronic phase)
CO., LTD.

56
 Development Status Targeted
Company Category Indication country Note
Korea Overseas

Supplement
prescription medicine Gastric Ulcer, Deodenal Launching Launching Any -
IL-YANG Ulcer, Erosive Esophagitis (China)
PHARM-
ACEUTICAL Vaccine Influenza Vaccine Launching - Any -
CO., LTD.
Biologic Ant-viral agent Pre-clinical - Any -
MAA
in progress
Abcertin Gaucher's disease Launched (a part of USA, EU
ISU Abxis Middle east
and South
America)
Fabagal Fabry's disease Launched NA USA, EU
CWP291 Cancer Phase 1 Phase 1 Global
JW
Pharm­ CreaVax-HCC Cancer Phase 3 - Global
aceutical
URC-102 Gout Phase 2 - Global
Controlled Release Formulation Analgesic Launched - Global
Controlled Release Formulation Antithrombotic Launched - Global
Fixed Dose Combination Antithrombotic Launched - Global
Korea New Dosage Formulation Antitussive Launched - Global
United
Pharm. Inc. Controlled Release Formulation Antithrombotic Clinical Trial - Global
Controlled Release Formulation GI modulator Clinical Trial - Global
Fixed Dose Combination Anti-hypertensive Clinical Trial - Global
Controlled Release Formulation Antitussive Clinical Trial - Global
Biologics Rheumatoid arthritis Phase 1 N/A Worldwide Antibody biosimilar
LG Life Small molecule Gout Phase 1 N/A Worldwide XO inhibitor
Sciences,
Ltd. P2Y12
Small molecule Atherothrombosis Phase 1 N/A Worldwide inhibitor
Medytox Biologics Glabellar Wrinkles, etc. phase 3 - - -
Inc. (Botulinum toxin product)
SA001 Dry eye syndrome Preclinical - Worldwide -
Samjin
Pharm- SA002 Obesity Preclinical - Worldwide -
aceutical SA003 Arthritis Preclinical - Worldwide -
Co., Ltd.
SA004 Hyperlipidemia Preclinical - Worldwide -
polymer-based Solubility
parenteral DDS Anti-cancer launching Ph 2 US, EU enhancing
tech.

polymer-based Solubility
parenteral DDS Anti-cancer Ph 1 - US, EU enhancing,
tech. Sustained
Samyang release
Biopharm- Better
aceuticals TDS tech. Neuropathic pain Ph 2 - US, EU patient
Corporation (completed) compliance

TDS tech. Severe pain Ph 1 - US, EU Marketed

(completed)
Safe
SiRNA DDS Anti-cancer Preclinical - US, EU polymer
based DDS
KOREA
MOTIE(Ministry
of Trade,
SP-8203 Anti-stroke Clinical(P1) - world wide Industry
and Energy)
supported
Project

Shin Poong KOREA

Pharm. KDDF(Korea
Co.,Ltd Medicurtain® Anti-adhension Launched Launched world wide Drug
Development
Fund) supported
Project
SP-35454 Osteoporosis - Clinical(P1) world wide
SP5M001 Osteo-arthrosis Clinical(P1) - world wide
SP5V003 Dermal filler Preclinical - world wide

57
 Development Status Targeted
Company Category Indication country Note
Korea Overseas
Supplement

ALK5 inhibitor Fibrotic disease Preclinical Preclinical Worldwide

GPR40 agonist Diabetes Preclinical Preclinical Worldwide
Endometriosis, uterine
GnRH antagonist myoma, BPH and breast / Phase I Preclinical Worldwide
prostate cancers
NCE407 Multiple Sclerosis Screening Screening Worldwide
NBP604 Hemophilia Preclinical Preclinical Worldwide
(rh. Factor VII)
SK Leuprolide Microsphere Anticancer Formulation - Worldwide
Chemicals
Co. Ltd. Anastrazole Anticancer Formulation - Worldwide
Microsphere
SID125 Erectile dysfunction NDA - Worldwide ODF
Montelukast ODF Asthma Launched - Worldwide ODF
SID141 Pain Screening - Worldwide Patch
SID143 Stroke, systemic embolism Screening - Worldwide Oral BA
enhancing
SKYCellflu Prevention for influenza Pre-launch Worldwide
virus
Plasmid DNA Perpheral Artery Disease Phase II US Phase II Global
(Completed) (Completed)
Plasmid DNA Diabetic Peripheral Phase II US Phase II Global
Neuropathy (Completed) (Completed)
Plasmid DNA Amyotrophic Lateral - US Phase I/II Global
ViroMed Sclerosis (Ongoing)
Co., Ltd. Phase I
Plasmid DNA Coronary Artery Disease (Completed) Global

Chemotherapy Induced China Phase

Recombinant Protein Thrombocytopenia - III Global
(Ongoing)
Botanical drug Allergy
New chemical Entity gastroesophageal reflux phase 2 USA, EU, Asia
disease
New chemical Entity irritable bowel syndrome Phase 1 USA, EU, Asia
Yuhan
Corporation New chemical Entity type 2 diabetes preclinical USA, EU, Asia
New chemical Entity degenerative disk disease phase 2 USA, EU
New bio medicine type 2 diabetes preclinical USA, EU

58
3. Certifications from Health Authorities
Company Product name Active Ingredient dosage form Indication International Note
certification

Supplement
Doxorubicin Doxorubicin API Oncology EU GMP scheduled
Fimasartan Fimasartan API Antihypertension EU GMP scheduled
Boryung
Pharm­ Linezolid Linezolid API Antibacterials PMDA
aceutical Alacepril Linezolid API Cardiovascular PMDA
co.,Ltd.
Pitavastatin Pitavastatin API Cardiovascular PMDA
Fexofenadine Fexofenadine API Antihistamine PMDA

Sepirom Ceftriaxone Sodium hydrate Injection Antibiotics PMDA

certification
Chong PMDA
Kun Dang Rasenazolin Cefazolin sodium Injection Antibiotics certification
pharm­
aceutical Pengood Bacampicillin hydrochloride Tablet Antibiotics PMDA
Corp. certification

Kmoxilin Amoxicillin/ Tablet Antibiotics Anvisa

Potassium clavulanate certification
Ceftazidime inj. Ceftazidime Inj. Infection Japan DMF
Ceftriaxone inj. Ceftriaxone Inj. Infection Japan DMF

Best-Call® Cefmenoxime Hcl Inj. Infection Japan GMP

Inspection
Supply
CJ First-Sin® Cefozopran Hcl Inj. Infection Japan GMP APIs to a
HealthCare Inspection Japanese
corporation Company
Pan-Sprorin® Cefotiam Hcl Inj. Infection Japan GMP
Inspection

Banan® tab. Cefopodoxime Tab. Infection Japan GMP Supply bulk-

Inspection products to
Japan GMP a Japanese
Banan® dry syrup Cefopodoxime Syrup Infection Inspection company
GemVax &
KAEL Co., RIAVAX® Tertomotide hydrochloride injection pancreatic cancer KGMP
Ltd.
Non-B-Lactam
solid dosage - - - Jordan
form

Coated tablets Metformine HCl - - Colombia

Glimepiride
Amaryl M Metformin HCl Film coated Diabetes Ivory Coast
1/250mg Glimepiride tablets Ukraine
Amaryl M Metformin HCl Film coated Diabetes Ivory Coast
2/500mg Glimepiride tablets Ukraine
Amaryl M SR Metformin HCl Film coated Diabetes Ukraine
2/500mg Glimepiride tablets
Handok Inc. Film coated
- - tablet - Taiwan

- - Ointment - Taiwan
- - Capsule - Taiwan
Certificate
Oman, for
South Africa, manufacturing
- - Tablets - Tanzania, line
Ethiopia, Yemen
(non-anticancer,
non-B-lactam)

- - Coated tablets - Brazil, Peru,

Saudi Arabia
EU GMP 2009
Pidogle Tab. Clopidogrel napadisilate Tablet Antithrombotic agent certification 2012
(Germany BGV)
Solid formulation Syria GMP 2012
Eye bath drops Certification
Hanmi
Pharm. Amosartan Tab. Amlodipine camsylate Kazakhstan
5/50mg, Losartan K Tablet Hypertension GMP 2012
5/100mg certification

Esomezole Cap. Esomeprazole strontium Kazakhstan

20mg, 40mg tetrahdyrate Capsule Gastroesopha geal reflux disease GMP 2012
certification

59
 Company Product name Active Ingredient dosage form Indication International Note
certification
Amosartan Tab.
Supplement

5/50mg, Amlodipine camsylate Tablet Hypertension Russia GMP 2012

5/100mg Losartan K certification

Cozaar XQ Amlodipine camsylate

5/50mg, Losartan K Tablet Hypertension Peru 2013
Hanmi 5/100mg
Pharm.
Solid formulation GCC 2013
Eye bath drops
Amosartan Tab. Amlodipine camsylate
5/50mg, Losartan K Tablet Hypertension Ukraine 2014
5/100mg
Epilido cartridge Lidocaine, cartridge Dental Anesthetics PMDA
1.8mL Adrenaline (injection)

Sodium chloride Ampoule Flushing compatible intravenous

injection 0.9% Sodium chloride (injection) tubing system and in dwelling US FDA (510K)
intravascular access devices.

Isotonic Sodium Plastic

HUONS Sodium chloride Ampoule Diluent for injectable drug PMDA
CO., LTD. chloride solution (injection)

Hypokalemia, cardiac collapse,

Plastic glucose supplement during
20% Glucose for Glucose Ampoule hypoglycemia, Cerebral edema, PMDA
injection (injection) Shock, Cardiac disease, Non-oral
supplement of water, Diagnosis of
diabetes
IL-YANG Japan
PHARM- IYEN2000 Taurine 2000, others Bottle Vitamin, Mineral & Nutrition Non-sterile -
ACEUTICAL Quasi-Drug
CO., LTDl GMP
Imipenem,
Cilastatin API - Antibiotics Japan GMP
Cefmetazole

Prepenem Inj. Imipenem monohydrate and Injection Antibiotics Japan GMP

JW Cilastatin sodium ANVISA
Pharm­
aceutical Pospenem Inj. Meropenem trihydrate Injection Antibiotics ANVISA

Itraconazole SD Itraconazole Solid Fungal Infection Japan GMP

Dispersion
Toracona Itraconazole Tablet Fungal Infection Japan GMP

Factive Gemcifloxacin Tablet Antibiotics FDA GMP -

certification
FDA GMP
hGH human Somatropin Injection Growth hormone deficiency certification -
EU GMP
certification
LG Life
Sciences, WHO GMP
Ltd. Euvax B Hepatits B vaccine Injection Hepatits B vaccine certification -
EU GMP
certification

Euforvac-Hib DTP-HepB-Hib vaccine Injection DTP-HepB-Hib vaccine WHO GMP -

certification
Hyruan plus Hyaluronic acid Injection Joint arthritis CE certification -

Medytox Biologics Botulinum toxin Vial Glabellar cGMP &

Inc. (Botulinum toxin type A (lyophilized) Wrinkles, etc. EU GMP
product)

Active Paclitaxel EU(Germany)

Pharmaceutical Docetaxel API Anti-cancer GMP 2014
Ingredient Synthetic Paclitaxel certification
Pemetrexed
Japan(PMDA)
Samyang Docetaxel(API) Docetaxel API Anti-cancer GMP 2013
Biopharm- certification
aceuticals
Corporation Oncology Oncology EU(Germany)
Injectables Injectables Injection Anti-cancer GMP 2012
certification

Oncology Oncology Japan(PMDA)

Injectables Injectables Injection Anti-cancer GMP 2010
certification

60
Company Product name Active Ingredient dosage form Indication International Note
certification
Japan(PMDA)

Supplement
Samyang Paclitaxel(API) Paclitaxel API Anti-cancer GMP 2010
Biopharm- certification
aceuticals Australia (TGA)
Corporation Diclofenac Diclofenac Plaster NSAIDs GMP 2010
Patch diethylammonium certification
PYRAMAX® Pyronaridine & Artesunate Tablet Anti-malaria EU GMP
Certification
Shin Poong
Pharm. Divaltan Tab. Valsartan - Anti-hypertensive agents JGMP(PMDA) API
Co.,Ltd
Newtinib Filim- Imatinib Mesylate - Anti-Neoplastics JGMP(PMDA) API
Coated Tab.
OMED Omeprazole Tablet Anti-ulcer Germany(EU)
SK Rivastigmine Rivastigmine Patch Alzheimer’s disease Germany(EU)
Chemicals Patch
Co. Ltd.
Plasma Blood product IRAN
derivatives
- Zidovudine API anti HIV/AIDS US FDA GMP- -
API
ST Pharm - Zidovudine API anti HIV/AIDS PMDA GMP-API -
Co., Ltd. - Zidovudine API anti HIV/AIDS TGA GMP-API -
- Zidovudine API anti HIV/AIDS ANVISA GMP- -
API
Xalost Plus Latanoprost plus Timolol Solution Anti-glaucoma EU GMP
maleate certification
TAEJOON
PHARM. Xalostplus Latanoprost Solution Anti-glaucoma EU GMP
CO., LTD. certification
MC Free Sodium CMC Solution Dry eye CE Marking
API 1 API 1 - USFDA, TGA raw material
API 2 API 2 - USFDA, TGA, PMDA raw material
API 3 API 3 - USFDA, TGA, PMDA raw material
PMH PMH - USFDA, TGA raw material
Yuhan Ribavirin Ribavirin - USFDA, EDQM raw material
Corporation
Voglibose Voglibose - PMDA raw material
Cilostazol Cilostazol - PMDA raw material
Levofloxacin Levofloxacin - PMDA raw material
Piperacillin Piperacillin - PMDA medicine

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memo
memo

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memo