LG Chem Life Sciences Factsheet
LG Chem Life Sciences Factsheet
LG Chem Life Sciences Factsheet
Life Sciences
FACTSHEET
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
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
Onsan Plant
2016 WHO prequalified fully liquid pentavalent vaccine (EUPENTA™)
- Chemical API Production
LR19052 Diabetes
LR19054 Diabetes
Based on our superior biotechnology and R&D capabilities accumulated since LR19051 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
LR19127 Cancer
LR19125 Cancer
LR19031 Cancer
LR19023 Cancer
LR19030 Alopecia
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
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.
HOW SUPPLIED
● 50/500mg : Zemimet® SR 50/500mg is oval shaped,
Chemicals Chemicals
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.
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
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
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
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
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
Avoid freezing.
SHELF LIFE
36 months
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 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
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
This booklet contains information about products which may or may not be available in any particular country, and if applicable, may have received approval or market
clearance by a governmental regulatory body for different indications and restrictions in different countries. Each country has specific law and regulations governing
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
an indication for any product which is not authorized by the laws and regulations of the country where the reader resides.