LG Chem Life Sciences Factsheet

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Innovation for a Better Life

Life Sciences
FACTSHEET

HEADQUARTER Life Sciences company Tel: +82-2-3773-1114


www.lgchem.com
LG Twin Towers E14 Block LG Science Park, 70,
128 Yeoui-daero Magokjungang 10-ro
Yeongdeungpo-gu, Seoul, Korea Gangseo-gu, Seoul, Korea

LGP-P-I001-2-JUL18
Chemicals
LG Chem
LG Hausys
LG Household & Healthcare
etc.

customer
and creating
17 Electronics
values in each field. LG Electronics
LG Display
LG Innotek
etc.

Telecommucation
29 & service
LG U+
LG CNS
LG International
Serveone
etc.
LG Chem
Business Area

Petrochemicals Energy Solution Advanced Materials Life Sciences

NCC IT & New Application Battery Automotive Material Primary Drug


PolyOlefins Automotive Battery IT Materials Specialty Drug
PVC / Plasticizers ESS Battery Industrial Materials Aesthetic
ABS
Acrylates / SAP
Rubber / Specual Polymers
Life Sciences
History & Milestone

Over 35 years of Experience in


Biopharmaceutical Business Manufacturing Facility

1981 Established as Biopharmaceutical Research Department

1990 In-house development and launch of 1st biopharmaceutical product Headquarter R&D center
(INTERMAX™-γ) in Korea - Business Unit - Vaccine Research
- Clinical Dev. - Biological Research
- Regulatory Affairs - NCE Research
1996 1st WHO prequalification of Hepatitis B vaccine (EUVAX B®) in Korea - Process & Formulation
Seoul

Osong Plant
2003 1st NCE approved by US FDA (FACTIVE®) in Korea - Vaccine (WHO PQ)
Production
- AID Production
Osong
- Future Product

2007 1st biologics approved by US FDA & EMEA (VALTROPIN®) in Korea


Ik-San
Onsan
2012 In-house development and launch of 1st diabetic drug (ZEMIGLO®)
in Korea
WHO prequalification of pentavalent vaccine (EUFORVAC- HIB™)

Onsan Plant
2016 WHO prequalified fully liquid pentavalent vaccine (EUPENTA™)
- Chemical API Production

2018 1st biosimilar (Eucept®) approved by PMDA in Japan


Iksan Plant
- HepB Vaccine (WHO PQ)
- Biological Drug Substance Production
Life Sciences
R&D Pipeline

Pharmaceuticals Development Pipeline


We have secured competitive edge in the pharmaceutical market, New Drug
based on our superior technologies and R&D capabilities. Project Code Indication Research Preclinical Phase I Phase II Phase III NDA

LR19052 Diabetes

LR19054 Diabetes

Based on our superior biotechnology and R&D capabilities accumulated since LR19051 Diabetes

1980s, we have been successful in developing a variety of original products Metabolic


LR19123 Diabetes

including Korea's first growth hormone for children, new drugs for Diseases
LR19018 Diabetes

diabetes, etc. At the same time, we have continuously expanded our LR19074 Gout

competitive edge through cooperation with global pharmaceutical companies. LR19021 Obesity

LR19020 Obesity

LR19131 Metabolic disease

LR19127 Cancer

LR19125 Cancer

Oncology LR19129 Cancer

LR19031 Cancer

LR19023 Cancer

LR19055 Autoimmune disease

LR19019 Autoimmune disease

Immunology LR19025 Degenerative disease

LR19024 Degenerative disease

LR19030 Alopecia

Medical Device and Vaccine


Project Code Indication Research Preclinical Phase I Phase II Phase III NDA

LR19059 (China) Dermal Filler


Asthetics
LR19059 (Europe) Dermal Filler

LR19113 Polio

Diphtheriae, tetanus,
Vaccine LR19122 pertussis, hepatitis B,
meningitis, polio
LR19115 pneumococcus
Zemiglo®/ Zemimet® SR / Zemiro® Tablet
Chemicals

Zemiglo® Tablet
The optimized DPP-4 inhibitor having potent INDICATION
efficacy, reliable safety and better compliance As monotherapy or In combination with
● metformin as initial therapy in treatment naive patients
benefits.
inadequately controlled by diet and exercise alone.
● metformin in patients with inadequate glycemic control

with the maximal tolerated dose of metformin alone.


● metformin and sulfonylurea in patients with inadequate

glycemic control with the maximal tolerated dose of


metformin and sulfonylurea dual therapy
DOSAGE & ADMINISTRATION
The recommended daily dose of Zemiglo® is 50mg
Zemiglo® can be taken with or without food.
No dosage adjustment is required for patients with renal
impairment and mild or moderate hepatic impairment.
HOW SUPPLIED
Zemiglo® is available as clear blisters (PVC/PVDC and aluminum).
Pack of 28 or 56 film-coated tablets in unit dose blisters.
COMPOSITION
Each tablet contains 68.9mg gemigliptin tartrate STORAGE CONDITION
sesquihydrate equivalent to 50mg of gemigliptin Store at room temperature (1~30℃) in tight container.

Products
SHELF LIFE
48 months

Zemimet® SR Tablet
Once daily DPP-IV inhibitor and Metformin SR 3) In combination with sulphonylurea in patients inadequately
combination product controlled on their maximal tolerated dose of metformin
and a sulphonylurea.
4) In patients already receiving an identical combination of
gemigliptin and metformin as separate tablets.

DOSAGE & ADMINISTRATION


The recommended dose of Zemimet®SR is once daily
Zemimet® SR should be generally administered once daily with
a meal in the evening.
The maximum recommended daily dose is 50mg gemigliptin
and 2000mg metformin extended-release.

HOW SUPPLIED
● 50/500mg : Zemimet® SR 50/500mg is oval shaped,

orange colored, film-coated tablet



25/500mg : Zemimet® SR 25/500mg is oval shaped,
COMPOSITION yellow colored, film-coated tablet
Four-dosage tablets contain active ingredients respectively; ● 50/1000mg : Zemimet® SR 50/1000mg is oblong shaped,
● 25/500mg : gemigliptin 25mg and metformin 500mg
brown colored, film-coated tablet
● 50/1000mg : gemigliptin 50mg and metformin 1000mg
● 25/1000mg : Zemimet® SR 25/1000mg is oblong shaped,
● 50/500mg : gemigliptin 50mg and metformin 500mg
yellowish-brown colored, film-coated tablet

25/1000mg : gemigliptin 25mg and metformin 1000mg
Opaque blisters (PVC/PVDC and aluminum). A pack of 28 or 56
INDICATION film-coated tablets in unit dose blisters.
Zemimet® SR is indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes STORAGE CONDITION
mellitus. Zemimet® SR can be administered Store at room temperature (1~30℃) in tight container.
1) As initial therapy for treatment naive patients with
inadequate glycemic control by diet and exercise alone. SHELF LIFE
2) In patients with inadequate glycemic control with the 36 months
maximal tolerated dose of metformin alone.
Zemiglo®/ Zemimet® SR / Zemiro® Tablet Rovatitan® Tablet

Chemicals Chemicals

Once daily ARB and Statin SPC drug for simultaneous


Zemiro® Tablet managment of hypertension and dyslipidemia
INDICATION
ROVATITAN® is indicated for the treatment of patients who
must administer both rosuvastatin and valsartan.
DPP-IV inhibitor and Statin combination for DOSAGE & ADMINISTRATION
Zemiro® is available as three doses 50/20 mg, 50/10 mg, 50/5 mg DOSAGE & ADMINISTRATION
concurrent treatment of diabetes and dyslipidemia
and taken once daily. Once-daily. Dosage must be individualized on the basis of both
effectiveness and tolerance of valsartan and rosuvastatin.
HOW SUPPLIED HOW SUPPLIED
● 5/80mg : light-orange colored, circular-shaped,
Zemiro® is available as a pack of 28 tablets and 56 tablets.
film-coated tablet
● 5/160mg : light-orange colored, oval-shaped,
● 50/20 mg : Zemiro® 50/20 mg is a round-shaped, dark green-colored
film-coated tablet. film-coated tablet
● 10/80mg : pink colored, circular film-coated tablet
● 50/10 mg : Zemiro® 50/10 mg is a round-shaped, light green-colored
● 10/160mg : pink colored, oval film-coated tablet
film-coated tablet. COMPOSITION
● 20/80mg : brown colored, circular film-coated tablet
● 50/5 mg : Zemiro® 50/5 mg is a round-shaped, yellowish green-colored Six-dosage tablets contain active ingredients respectively;
film-coated tablet.

20/160mg : brown colored, oval film-coated tablet

5/80mg : rosuvastatin 5mg and valsartan 80mg
● 5/160mg : rosuvastatin 5mg and valsartan 160mg STORAGE CONDITION
● 10/80mg : rosuvastatin 10mg and valsartan 80mg Store at room temperature (1~30℃) in light-resistant
● 10/160mg : rosuvastatin 10mg and valsartan 160mg tight container.
COMPOSITION STORAGE CONDITION ● 20/80mg : rosuvastatin 20mg and valsartan 80mg
Zemiro® is available as three doses which contain gemigliptin Store in room temperature (1-30°C) ● 20/160mg : rosuvastatin 20mg and valsartan 160mg SHELF LIFE
tartaric acid sesquihydrate and rosuvastatin calcium. 36 months
SHELF LIFE
● 50/20 mg : gemigliptin 50 mg/rosuvastatin 20 mg
30 months
● 50/10 mg : gemigliptin 50 mg/rosuvastatin 10 mg
● 50/5 mg : gemigliptin 50 mg/rosuvastatin 5 mg
Factive® Tablet / Injection
INDICATION Chemicals
Zemiro® is a combination of gemigliptin and rosuvastatin
indicated for patients who require administration of both
products. US FDA approved respiratory fluoroquinolone INDICATION, DOSAGE & ADMINISTRATION
antibiotic, gemifloxacin. Indication : Dose and duration of therapy depending on the type
of indications are described in the following Table.
The dose of Factive® is 320mg (orally) or 200mg (as an
Factive® is a dual targeting quinolone with broad spectrum
intravenous injection) once every 24 hours.
marketed more than 20 countries including US.
Intravenous formulation has been approved in Korea. Indication Dose every 24 hours Duration (days)
Acute bacterial exacerbation
320 mg(oral), 200mg(IV) 5
COMPOSITION of chronic bronchitis
Factive® Tablet : Each tablet contains gemifloxacin mesylate Community-acquired pneumonia 320 mg(oral), 200 mg(IV) 7 to 14
equivalent to 320mg of gemifloxacin Acute bacterial sinusitis 320 mg(oral), 200 mg(IV) 5 to 7
Factive® Injection : Each vial contains gemifloxacin mesylate Otitis media 320 mg(oral), 200 mg(IV) 7
equivalent to 200mg of gemifloxacin Complicated Urinary Tract 320mg(oral) 10
Infections and Pyelonephritis
Uncomplicated urinary tract infections 320 mg(oral) 3
*Different countries have different approved indication, formulation
and duration.

HOW SUPPLIED
Factive® tablet : white to off-white, oval, film-coated tablet
Factive® injection : White to light brown lyophilized powder
in a brown vial
STORAGE CONDITION
Factive® tablet : Store at 1~30℃ in tight container,
Protect from light.
Factive® injection : Store at 1~30℃, Protect from light.
SHELF LIFE
Factive® tablet : 48 months
Factive® injection : 36 months
Eucept Etanercept Injection Espogen® / Epotiv® Erythropoietin Injection

Biologics Biologics

The FIRST biosimilar of Etanercept ever developed DOSAGE & ADMINISTRATION Free from human serum albumin, manufactured COMPOSITION
by LG Chem. For adult patients(≥18 years old); by bioreator precess. ● Each pre-filled syringe contains 1,000, 2,000, 3,000, 4,000,
6,000, 8,000 or 10,000 IU of rhEPO
● Rheumatoid arthritis, psoriatic arthritis, ankylosing
Sophisticated analytical tools and methods are used to Espogen® is a recombinant human erythropoietin for the
● Each vial contains 4,000, 10,000 or 20,000 IU of rhEPO
spondylitis and non-radiographic axial spondyloarthritis
compare the characteristics of Eucept to the reference product treatment of anemia induced by chronic renal failure in
on the very fine details of the molecule using the state-of-art patients with or without dialysis. It is manufactured by INDICATION
25mg Etanercept administered twice weekly subcutaneously
technology. Head-to-head comparisons of Eucept and the
or 50mg administered once weekly subcutaneously. bioreactor process which does not use animal-derived material, Treatment of anemia of chronic renal failure(CRF) patients
reference product were performed in the clinical trials to
is free from human serum albumin.
demonstrate the safety and efficacy with active RA patients. ● Plaque psoriasis DOSAGE & ADMINISTRATION
25mg Etanercept administered twice weekly subcutaneously ● Recombinant human erythropoietin using CHO cells ● Initial dose : Administer 50 IU/kg, 3 times a week or 150
or 50mg administered once weekly subcutaneously. ● Manufactured by bioreactor process capable of covering IU/kg once a week by SC or IV injection over 1~2 minutes
● Available in prefilled syringe and autoinjector Alternatively, 50mg given twice weekly may be used for high capacity ● Maintenance dose : If 30~35% of Hct level is achieved,
● Easy-to-grip autoinjector up to 12 weeks followed, if necessary, by a dose of ● Devoid of additives derived from animal origin in the administer 20~50 IU/kg, 2~3 times a week, in any case,
25mg twice weekly or 50mg once weekly. Treatment manufacture process maximum dose should not exceed 200IU/kg in a single day,
with Etanercept should continue until remission is ● Safe and effective treatment for renal anemia associated 3 times per week.
achieved, for up to 24 weeks. Continuous therapy beyond with chronic renal failure (CRF)
24 weeks may be appropriate for some adult patients. ● Newly developed for global market HOW SUPPLIED
Treatment should be discontinued in patients who show
no response after 12 weeks. If re-treatment with Vial : 10 vials / box
Etanercept is indicated, the same guidance on treatment PFS : 6 syringes / box
duration should be followed. The dose should be 25mg
twice weekly or 50mg once weekly. Based upon physician STORAGE CONDITION
judgement and individual patient needs, continuous or Store in hermetic container at 2-8℃. Do not freeze or shake.
intermittent treatment can be used. In intermittent
treatment, after initial period of treatment, 25mg
SHELF LIFE
Etanercept administered twice weekly subcutaneously, or
50mg administered once weekly subcutaneously. 24 months

HOW SUPPLIED
25mg/0.5mL prefilled syringe
50mg/1.0mL prefilled syringe
50mg/1.0mL autoinjector

STORAGE CONDITION
COMPOSITION ● Store in a refrigerator (2℃~8℃). Do not freeze.
● Each prefilled syringe contains 25mg or 50mg of Etanercept ● Etanercept may be stored at temperatures up to a
● Each autoinjector contains 50mg of Etanercept maximum of 25℃ for a single period of up to four weeks;
after which, it should not be refrigerated again.
Etanercept should be discarded if not used within four
INDICATION weeks of removal from refrigeration.
For adult patients (≥18 years old); ● Keep the product in the outer carton in order to protect
a . Rheumatoid Arthritis (RA) from light.
b . Psoriatic Arthritis (PsA)
c . Axial Spondyloarthritis (axSpA) SHELF LIFE
d . Plaque Psoriasis (PsO) 30 months
Eutropin® / Eutropin® Pen Somatropin Injection Eutropin® Plus Somatropin Injection

Biologics Biologics

LG Chem is committed to leadership and innovation INDICATION The FIRST once-a-week hGH product with proven COMPOSITION
in GHD therapy. Short stature due to an inadequate secretion of endogenous efficacy and safety comparable to daily products. Each vial contains 24mg of recombinant human growth
growth hormone in prepubertal children (Pediatric Growth Satisfies needs of patient groups requiring reduced hormone
Hormone Deficiency, PGHD)
● Manufactured using LG Chem’s advanced technology frequency of injections.
Short stature caused by Turner Syndrome (TS) in prepubertal INDICATION
: Drug substance approved by US FDA children Short stature due to an inadequate secretion of endogenous
● Uniquely produced in yeast ( Saccharomyces cerevisiae ) Short stature caused by Chronic Renal Insufficiency (CRI) in growth hormone in prepubertal children (Pediatric Growth
: GRAS by FDA hence, non-pathogenic and non-pyrogenic prepubertal children Hormone Deficiency, PGHD)
● Proven quality : Proven efficacy and safety, 20 years of Short stature in prepubertal children born Small for
patient experience Gestational Age (SGA) DOSAGE & ADMINISTRATION
Short stature associated with Idiopathic Short Stature (ISS) in
prepubertal children 0.5mg/kg/week, subcutaneously.

Eutropin® Injection 4 IU Replacement therapy in adults with GH deficiency of either


childhood- or adult-onset etiology HOW SUPPLIED
24mg/vial with accompanying solvent in a pre-filled
COMPOSITION
DOSAGE & ADMINISTRATION syringe/unit
Each vial contains 4 IU of recombinant human growth hormone
1. PGHD : 0.5~0.6IU/kg/week or 12IU/m2(body surface area)/
STORAGE CONDITION
week, 3 or 6 times per week, subcutaneously.
2. TS : 1IU/kg/week, 6 to 7 times per week, subcutaneously or Store at 2~8℃. Do not freeze.
intramuscular. Keep out of reach of children.
3. CRI : 0.15IU/kg/day, subcutaneously.
4. SGA : 0.48mg/kg/week, 6 to 7 times per week, SHELF LIFE
subcutaneously. 36 months
5. ISS : 0.37mg/kg/week, 6 times per week, subcutaneously.
6. Replacement therapy in adult GHD : A starting dose
of 0.125IU/kg/week may be increased to a maximum
0.25IU/kg/week, 6 to 7 times per week.

HOW SUPPLIED
4 IU/vial x 1, 5, 10 vials/pack (with solvent)
15 IU/vial x 1 vial/pack (with solvent) Declage® Somatropin Injection
36 IU/pen/pack
Biologics
Eutropin® Pen Injection 36 IU STORAGE CONDITION
Store in hermetic container at 2~8℃.
Once weekly hGH product for AGHD (Adult COMPOSITION
COMPOSITION SHELF LIFE Growth Hormone Deficiency) patients Each vial contains 3mg of recombinant human growth
Each pen contains 36 IU of recombinant human growth 4 IU : 36 months hormone
hormone 15 IU : 36 months
36 IU : 18 months INDICATION
Replacement therapy in adults with GH deficiency of either
childhood- or adult-onset etiology

DOSAGE & ADMINISTRATION


The recommended dosage at the start of therapy is 2mg/
week. The dose may be increased according to individual
patient requirements to a maximum of 4mg/week.

HOW SUPPLIED
3mg/vial with accompanying solvent in a pre-filled
syringe/unit

STORAGE CONDITION
Store at 2~8℃. Do not freeze.

SHELF LIFE
36 months
Hyruan® Series Viscosupplementation for osteoarthritis treatment Protescal™ Post-operative anti-adhesive agent

HA Based Products HA Based Products

It is a biodegradable and absorbable adhesion barrier composed of sodium hyaluronate, carboxymethylcellulose (CMC) and sodium alginate.
Since early 1990s, LG’s sodium hyaluronate is microbially fermented using Streptococcus zooepidemicus with high purity
It effectively prevents the formation of adhesions between tissues after intrauterine surgery and degrades safely in our body.
and consistency. To pursue the global standard, our hyaluronate gained Certificate of Suitability from European Directorate
for the Quality of Medicines (EDQM).
DESCRIPTION
Treatment of degenerative joint diseases This is a viscous solution type product presented in a prefilled
Hyaluronic acid is a natural polysaccharide which moisturizes and lubricates the body's soft tissue. It protects injured chondrocyte by syringe filled with 1.5mL, 5.0mL of colorless, clear and viscous
building proteoglycan aggregates and suppressing degenerative change of cartilage. It is the major macromolecule species in synovial liquid.
fluid and is responsible for the fluid's viscoelastic properties.
INDICATION
It is mainly used after the intrauterine surgery to reduce the
Hyruan ONE® adhesion of the surrounding tissues as a dressing for deep
cavity wounds.
Novel single injection with cross-linked HA COMPOSITION HOW SUPPLIED
Each mL contains 20mg of cross-linked sodium hyaluronate 1.5mL, 5.0mL in a prefilled syringe/box
INDICATION STORAGE CONDITION
For use as a symptomatic treatment for osteoarthritis of the knee 2~25℃, Free from light, in a hermetic container.
DOSAGE & ADMINISTRATION
3.0mL at once by intra-articular injection SHELF LIFE
24 months
HOW SUPPLIED
3.0mL in a prefilled syringe/box
STORAGE CONDITION
Store in hermetic container at 1-30℃. Protect from light.
SHELF LIFE
24 months
Hyal® Series Injection for ophthalmic surgery

Hyruan Plus® HA Based Products

Three-injection with high molecular weight HA COMPOSITION Hyal 2000® and Hyal Plus® are sodium hyaluronate, which are sterile non-pyrogenic high molecular weight viscoelastic substances for
Each mL contains 10mg of sodium hyaluronate intraocular surgeries. They protect the endothelium from injury, enhance endogenous endothelial regeneration and allow safe manipulation
INDICATION during ophthalmic sergeries.
Osteoarthritis of the knees and periarthritis of the shoulder
DOSAGE & ADMINISTRATION
2.0mL once a week for 3 weeks by intra-articular injection Hyal Plus® Hyal 2000®
HOW SUPPLIED COMPOSITION COMPOSITION
2.0mL in a prefilled syringe X 1, 3/box Each mL contains 15mg of sodium hyaluronate Each mL contains 10mg of sodium hyaluronate
STORAGE CONDITION INDICATION INDICATION
Store in hermetic container at 2-25℃. Protect from light. Used in surgical interventions involving the anterior chamber, Used in surgical interventions involving the anterior chamber,
SHELF LIFE such as cataracts (crystalline lens transplants), corneal such as cataracts (crystalline lens transplants), corneal
24 months transplants and glaucoma operations transplants and glaucoma operations

Hyruan® DOSAGE & ADMINISTRATION


Injection volume is adjusted according to the type of eye
DOSAGE & ADMINISTRATION
Injection volume is adjusted according to the type of eye
surgery: surgery:
Five-injection with low molecular weight HA COMPOSITION ● Cataract Surgery and Intraocular Lens Implantation ● Cataract Surgery and Intraocular Lens Implantation
Each mL contains 10mg of sodium hyaluronate ● Keratoplasty ● Keratoplasty

● Glaucoma Filtration Surgery ● Glaucoma Filtration Surgery


INDICATION
Osteoarthritis of the knees and periarthritis of the shoulder HOW SUPPLIED HOW SUPPLIED
0.85mL in a prefilled syringe/box 0.85mL in a prefilled syringe/box
DOSAGE & ADMINISTRATION
2.5mL once a week for 5 weeks by intra-articular injection STORAGE CONDITION STORAGE CONDITION
Store in hermetic container Store in hermetic container
HOW SUPPLIED
at 2-8℃ in the refrigerator. at 2-8℃ in the refrigerator.
2.5mL in a prefilled syringe X 1, 5/box
Protect from light. Protect from light.
STORAGE CONDITION
SHELF LIFE SHELF LIFE
Store in hermetic container at 2-8℃ in the refrigerator. 36 months 36 months
Protect from light.
SHELF LIFE
36 months
YVOIRE® Dermal Filler YVOIRE® Dermal Filler

HA Based Products HA Based Products

Tissue augmentation and wrinkle correction


Based on the original technology for manufacturing high-quality sodium hyaluronate, LG Chem developed a biomaterial for tissue
augmentation using the cross-linked sodium hyaluronate. It is injected into the facial skin layer in the face using separate needles
supplied with. YVOIRE® series use HICE(High Concentration Equalized) crosslinking technology which effectively stabilizes high concentration,
high molecular weight HA.

YVOIRE® classic s YVOIRE® classic plus YVOIRE® contour s YVOIRE® contour plus
COMPOSITION COMPOSITION COMPOSITION COMPOSITION
Cross-linked sodium hyaluronate 22mg/mL(2.2%) Cross-linked sodium hyaluronate 20mg/mL (2.0%) Cross-linked sodium hyaluronate 22mg/mL (2.2%) Cross-linked sodium hyaluronate 20mg/mL (2.0%)
Lidocaine hydrochloride 0.3% Lidocaine hydrochloride 0.3%
INDICATION INDICATION
Facial tissue augmentation by injection into areas in INDICATION Facial tissue augmentation typically used for treatment of INDICATION
which restoration is required. Typically used for Facial tissue augmentation by injection into areas in extreme facial wrinkles and folds, and also replacement of Temporary wrinkle improvement and recovery of volume loss
treatment of facial wrinkles and folds, and also for which restoration is required. Typically used for treatment volume defects, facial lipoatrophy and improvement of facial by injection into the facial skin layer
augmentation of lips. of facial wrinkles and folds, and also for augmentation of contour deformities by injection in the facial subcutaneous The addition of lidocaine provides a pain relieving effect
lips. The addition of lidocaine provides a pain relieving and supraperiosteal facial layers during treatment.
HOW SUPPLIED
effect during treatment.
1.0mL in a prefilled syringe/box HOW SUPPLIED HOW SUPPLIED
with 27G & 30G needles HOW SUPPLIED 2.0mL in a prefilled syringe/box 1.0mL in a prefilled syringe/box
1.0mL in a prefilled syringe/box with 21G & 23G needles with 23G cannula & 23G needle
STORAGE CONDITION
with 27G & 30G needles
2~25℃ free from light, in a hermetic STORAGE CONDITION STORAGE CONDITION
container. STORAGE CONDITION 2~25℃ free from light, in a hermetic 2~25℃ free from light, in a hermetic
2~25℃ free from light, in a hermetic container. container.
SHELF LIFE
container.
24 months SHELF LIFE SHELF LIFE
SHELF LIFE 24 months 24 months
24 months

YVOIRE® volume s YVOIRE® volume plus YVOIRE® hydro


COMPOSITION COMPOSITION COMPOSITION
Cross-linked sodium hyaluronate 22mg/mL(2.2%) Cross-linked sodium hyaluronate 20mg/mL (2.0%) Sodium hyaluronate 20mg/mL (2.0%)
Lidocaine hydrochloride 0.3%
INDICATION INDICATION
Facial tissue augmentation by injection into areas in INDICATION Temporary relief of wrinkles by injection into the skin layer
which restoration is required. Typically used for Facial tissue augmentation by injection into areas in which around the facial wrinkle area
treatment of severe facial wrinkles and folds, and restoration is required. Typically used for treatment of HOW SUPPLIED
also for augmentation of lips. severe facial wrinkles and folds, and also for augmentation 1.0mL in a prefilled syringe/box
of lips. The addition of lidocaine provides a pain relieving with two 30G needles
HOW SUPPLIED
effect during treatment.
1.0mL in a prefilled syringe/box
STORAGE CONDITION
with two 27G needles HOW SUPPLIED
2~8℃
1.0mL in a prefilled syringe/box
STORAGE CONDITION
with two 27G needles SHELF LIFE
2~25℃ free from light, in a hermetic
container. 24 months
STORAGE CONDITION
SHELF LIFE 2~25℃ free from light, in a hermetic
container.
24 months
SHELF LIFE
24 months
YVOIRE® Y-Solution™ Dermal Filler Follitrope® Injection 75, 150, 225, 300 IU

HA Based Products Infertility Treatments

Recombinant Human Follitropin (FSH) lyophilized COMPOSITION


powder in vial and liquid formulation in prefilled Each vial contains 75 or 150 IU of recombinant follitropin
YVOIRE® Y-SolutionTM 360 YVOIRE® Y-SolutionTM 540 syringe for injection.
(FSH). Each prefilled syringe contains 75,150, 225 or 300 IU of
recombinant follitropin (FSH).
COMPOSITION COMPOSITION INDICATION
Cross-linked sodium hyaluronate 12mg/mL(1.2%) Cross-linked sodium hyaluronate 20mg/mL(2.0%) Controlled ovarian hyperstimulation (COH) to induce the
Lidocaine hydrochloride 0.3% Lidocaine hydrochloride 0.3% development of multiple follicles in medically assisted
INDICATION INDICATION reproduction program (e.g. in vitro fertilization/embryo transfer;
Temporary wrinkle improvement and recovery of volume loss IVF/ET, gamete intra-fallopian transfer; GIFT, zygote intra-
Temporary wrinkle improvement and recovery of volume
by injection into the facial skin layer fallopian transfer; ZIFT, intracytoplasmic sperm injection; ICSI).
loss by injection into the facial skin layer
The addition of lidocaine provides a pain relieving effect Anovulation in clomiphene-resistant anovulatory infertility women
The addition of lidocaine provides a pain relieving effect
during treatment. during treatment. (WHO Group II, including polycystic ovarian disease (PCOD)).
ADMINISTRATION
HOW SUPPLIED HOW SUPPLIED
Subcutaneous or intramuscular injection
1.0mL in prefilled syringe/box 1.0mL in prefilled syringe/box
with two 29G needles with two 27G needles HOW SUPPLIED

Follitrope® Inj. vial :
STORAGE CONDITION STORAGE CONDITION
75 IU 1 vial per pack (with its accompanying solvent in vial)
2~25℃ free from light, 2~25℃ free from light,
150 IU 1, 5 vials per pack (with its accompanying solvent in vial)
Follitrope® Inj. prefilled syringe :
in a hermetic container. in a hermetic container. ●

SHELF LIFE 75, 150, 225, 300 IU 1 prefilled syringe/pack


SHELF LIFE
17 months 17 months
STORAGE CONDITION
● Follitrope® Inj. vial :
Store below 25℃ in hermetic container protected from light.
Follitrope® Inj. prefilled syringe :
● Store between 2-8℃ in hermetic container protected from light.

Avoid freezing.
SHELF LIFE
36 months

YVOIRE® Y-SolutionTM 720


COMPOSITION
IVF-M HP™ Injection 75 IU
Cross-linked sodium hyaluronate 20mg/mL(2.0%) Infertility Treatments
Lidocaine hydrochloride 0.3%
INDICATION
IVF-M HP™ Injection is a preparation of highly COMPOSITION
Temporary wrinkle improvement and recovery of volume
purified human menopausal gonadotropin Each vial contains 75 IU of FSH and 75 IU of LH
loss by injection into the facial skin layer
The addition of lidocaine provides a pain relieving effect (Menotropin HP) extracted from the urine of INDICATION
during treatment. postmenopausal women, which contains follicle Female : For stimulation of the development of multiple
follicles(superovulation) in women undergoing Assisted
HOW SUPPLIED stimulating hormone(FSH) and luteinizing
1.0mL in prefilled syringe/box Reproductive Techniques(ART),
hormone (LH) activity in the ratio of For ovulatory disorder - Ovulation induction
with two 27G needles
approximately 1.
STORAGE CONDITION ADMINISTRATION
Subcutaneous injection
2~25℃ free from light,
in a hermetic container. HOW SUPPLIED
SHELF LIFE 75 IU/vial X 1 vial/pack (with solvent)
17 months STORAGE CONDITION
Store in the light-resistant place at RT (1~30℃).

SHELF LIFE
36 months
IVF-M™ Injection 75,150 IU Euvax B™ Injection
Infertility Treatments Hep B Vaccine

IVF-M™ Injection is a preparation of human COMPOSITION Recombinant hepatitis B vaccine suspension for CLASS
menopausal gonadotropin (Menotropin) extracted Each vial contains 75 or 150 IU of FSH and 75 or 150 IU of LH Monovalent Vaccine
injection
from the urine of postmenopausal women, which INDICATION COMPOSITION
Highly qualified, safe and effective Each ml of Euvax B™ Inj. contains
contains follicle stimulating hormone (FSH) and Female : For stimulation of the development of multiple follicles
● Prequalified by WHO (first in Korea) & Certified as EU GMP
luteinizing hormone (LH) activity in the ratio of (superovulation) in women undergoing Assisted
● Major supplier of UN Agencies Active ingredient : Purified HBsAg (rDNA) 10 or 20 ㎍
Reproductive Techniques (ART),
approximately 1. ● Produced by recombinant DNA technology expressed in Adjuvant : Aluminum hydroxide gel (as Al) 0.5 mg
For ovulatory disorder - Ovulation induction
yeast cell (Saccharomyces cerevisiae) INDICATION
Male : Hypogonadotropic hypogonadism ● Free from components of human origin
Immunization against infection caused by all known subtypes of
ADMINISTRATION ● Over 600 million doses have been used worldwide
hepatitis B virus
Subcutaneous or intramuscular injection ● Effective protection in all age groups with a variety of
DOSAGE & ADMINISTRATION
HOW SUPPLIED vaccination schedules
0.5 ml (10 ㎍ HBsAg) is administered to neonates, infants
● Preservative free
75 IU/vial X 1 vial/pack (with solvent) and children aged up to 15 years and 1.0 ml (20 ㎍ HBsAg)
150 IU/vial X 1, 5 vials/pack (with solvent) composition is administered to adult aged from 16 years, by intramuscular
injection
STORAGE CONDITION
● Basic immunization schedule : 0-1-6 months
Store in the light-resistant place at RT (1~30℃).
● Alternate immunization schedule : 0-1-2 months

SHELF LIFE
36 months STORAGE CONDITION
Store at 2~8℃. Do not freeze.
SHELF LIFE
36 months

IVF-C™ Injection 1000, 5000 IU Euhib™ Injection


Infertility Treatments Hib Vaccine

IVF-C™ Injection is a preparation of human COMPOSITION Haemophilus influenzae type b (Hib) vaccine CLASS
chorionic gonadotropin (hCG) extracted from Each vial contains 1,000 or 5,000 IU of hCG Monovalent Vaccine
Lyophilized powder with a diluent in pre-filled
the urine of pregnant women. INDICATION syringe for injection COMPOSITION
Female : Ovulation induction in women undergoing Assisted Each single dose of 0.5ml contains
Reproductive Techniques (ART), Anovulatory Infertility,
High-tech, effective and safe Lyophilized powder :
Inadequate Luteal Phase, Habitual Abortion &
Threatened abortion - Purified capsular polysaccharide (PRP)
● The first Hib tetanus toxoid conjugate vaccine to be 30~50㎍ (as PRP 10 ㎍)
of Hib conjugated to tetanus toxoid
developed with second-generation conjugate technology
Male : Hypogonadotropic hypogonadism - Lactose 10.08 mg
in Korea
ADMINISTRATION ● One of the Korea’s 10 Best New Technologies of 2011 Diluent :
Intramuscular injection ● Awarded a prize from Minister of Knowledge Economy - Sodium chloride 0.9% (w/v)
HOW SUPPLIED ● Highly immunogenic and well tolerable to the healthy - Water for injection q.s.
1,000 IU/vial X 1 vial/pack (with solvent) infants
5,000 IU/vial X 1, 3 vials/pack (with solvent) ● Preservative free composition INDICATION
Active immunization of infants and toddlers from the age of
STORAGE CONDITION 2 months for prevention of invasive disease caused by
Store in the light-resistant cool place (below 15℃). Haemophilus influenzae type b
SHELF LIFE DOSAGE & ADMINISTRATION
24 months 3 doses (1 dose = 0.5 ml) at 2, 4 and 6 months of age and a
booster dose of 0.5 ml at 12~15 months of age, by
intramuscular injection

STORAGE CONDITION
Store at 2~8℃. Do not freeze.
SHELF LIFE
36 months
Eupenta™ Injection
The largest Convergence R&D Complex in Korea
DTwP-Hep B-Hib

Adsorbed Diphtheria, Tetanus, whole-cell CLASS


Pertussis, Hepatitis B (r-DNA) and Hib vaccine Pentavalent Vaccine
Suspension for injection COMPOSITION
Each single dose of 0.5mL contains

Effective, safe and convenient Diphtheria toxoid 15 Lf


● Highly immunogenic and well tolerable to the Tetanus toxoid 10 Lf
healthy infants Pertussis antigen ≥ 4 IU
● Improved compliance
Purified HBsAg (r-DNA) 10 ㎍
● Long shelf life
Purified capsular polysaccharide (PRP) 30~50 ㎍
● Manufactured under world-class GMP standards
of Hib conjugated to tetanus toxoid (as PRP 10 ㎍)

INDICATION
Active primary immunization against diphtheria, tetanus,
pertussis, hepatitis B and Haemophilus influenzae type b disease
DOSAGE & ADMINISTRATION
3 doses (1 dose = 0.5ml) at 6, 10 and 14 weeks of age, by
intramuscular injection
STORAGE CONDITION
Store at 2~8℃. Do not freeze.

SHELF LIFE
36 months

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the communication of medical or other information about medical products. Nothing herein should be construed as a solicitation or promotion for any product or for
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