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Produced by:
Korean Biologics Pipelines 2015
Series eBook of 4th Biologics World Korea 2015
As 4th Biologics World Korea 2015 is drawing near, we are glad to compile the
key information of 17 leading Korean Biologics manufacturers and highlight their
pipelines for your interest and discussion.
PREFACE
CONTENT
The ranking is in no particular order and listed alphabetically
The content of this e-Book only represents the opinions of IMAPAC
All information is provided by our partners or retrieved from our
partner and Internet
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Binex Co., Ltd.
Bioneer Corporation
Boryung Pharmaceuticals Co., Ltd.
Celltrion, Inc.
Chong Kun Dang Pharmaceutical
Corporation
CJ Healthcare Corporation
Daewoong Pharmaceutical Co., Ltd.
Green Cross Corporation
HanAll BioPharma Co., Ltd.
Handok Inc.
Hanmi Pharmaceutical Co., Ltd.
Il-Yang Pharmaceutical Co., Ltd.
ISU Abxis Co., Ltd.
JW Pharmaceutical Co., Ltd.
LG Life Sciences, Ltd.
SK Biopharmaceauticals
SK Chemicals Co., Ltd.
ViroMed Co, Ltd.
Yuhan Corporation
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Since its establishment in 1957, Binex has been dedicated to providing sustainable solutions to healthcare challenges in Korea. Binex is currently comprised of three main business sectors: biologics, chemicals, and cell therapy.
BINEX is the CDMO (contract development and manufac-turing organization) in Korea that solves manufacturing bottleneck in biologics industry with proven track records of carrying out GMP manufacturing & process development roles for global market. As the manufacturing hub, BINEX was able to accumulate manufacturing experience and know-how for various types of biologics at the highest GMP standards because BINEX has managed most biologicsdeveloped in Korea.
Through its manufacturing expertise, BINEX has beenspotted for dealing with multinational pharmaceuticalcompanies by providing top-quality biologics CDMOservice and we are looking forward to expanding ourglobal business capability continuously.
Remicade is one of the top selling biologics with $8.5 billlion in sales in 2011. This monoclonal antibody drug has a broad indication including Rheumatoid Arthritis and othe inflam-matory conditions. Currently, the clinical phase 1 study of Remicade Biosimilar with RA patients has been completed in Korea and Japan, and phase III study with RA patients has been started in Japan
CEO:Address:
Website:Phone:
E-mail:
Myoung-Ho Jeong368-3, Dadae-ro, Saha-gu,Busan, 604-846 Koreawww.bi-nex.comSeo Yeon [email protected]
Binex Co., Ltd.
Bio Base Camp for Biopharmaceutical Industry Binex Co., Ltd.
Product Name
Human Growth Hormone
Hylene
Otra
Allernol
Growth Hormone Deficiency
Treatment ofKeratoconjunctivitis
(Ophthalmic Solution)
Treatment of bacterial infections (Ophthalmic
Solution)Treatment of allergic
conjunctivitis(Ophthalmic Solution)
Currently Marketed
Currently Marketed
Currently Marketed
Currently Marketed
Indication Status
Products
Product Name
Remicade Biosimilar Rheumatoid Arthritis, etc. Phase III
(Completed)
Indication Status
R&D Pipeline
4
Bioneer Corporation is Korea’s leading biotech company. Bioneer was the first Korean biotechnology company when itwas established in 1992. The company has developed state of art molecular biology products and technologies includingoligonucleotides/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 & instruments. By capitalizing on thefoundational technologies and products developed over 10 years, Bioneer has developed a solidvertically integrated infrastructure to support new higher value-added businesses such as novel RNAi drugdevelopment and molecular diagnostics.
SAMiRNA (Self-Assembled-Micelle-inhibitory-RNA) is a novel class of RNAi molecule consisting of RNA, lipid and PEG, which is stable nanoparticle in blood stream and efficient in vivodelivery and finally converted to siRNA in the target cells. SAMiRNA is a SCE (single Chemical Entity), which ismanufactured by the proprietary solid-phase synthesis 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. SAMiRNA itself includes its flexibility to incorporate siRNA sequences against any disease target, as well as enhancement of its therapeutic potential as a targeted delivery by the addition of cell-type specific ligands on SAMiRNA.
These features and pre-clinical research data suggest that SAMiRNA is the most unique and singularly effective RNAiprodrug 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-class 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 which have more than 10 year experience ensure top-quality products and developments to meet unmet therapeutic needs.
Bioneer is currently advancing clinical development of pipeline programs for previously non-druggable targets, including cancer, COPD, liver fibrosis, and antivirals, internally with our research and develop-ment resources as well as through partnerships with major global pharmaceutical companies.
CEO:Address:
Website:Phone:
E-mail:
Han-Oh Park, Ph.D.49-3, Munpyeong-dong, Daedeok-gu, Daejeon306-220, Koreawww.bioneer.comJei-Wook Chae, Ph.D.,Head of R&D [email protected]
Bioneer Corporation
Leadership in RNAi Therapeutics:
Bioneer’s siRNA Drug Development Program using SAMiRNA Technology
R&D PipelinePreclinicalDevelopmentDiscoveryPrograms Clinical Trials
Phase I Phase II Phase III
Solid Cancers(SAMiRNA Survivin)
Liver CancerSANDFI
COPD
Liver FibrosisAntivirals
Bioneer Programs
Partner Program
5
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 conducted R&D activities to develop drug substances from a short-term perspective and developing new drugs for future market from a mid-to long-term perspective. In particular, Boryung Pharmaceutical makes an effort to strengthen the product pipelines in the specialty areas such as cardiovascular drug, antineoplastic drug and antibiotic/antiviral etc.
CEO:Address:
Website:Phone:
E-mail:
Tae Hong, ChoiHead Office 136,Changgyeonggung-ro,Chongro-ku, Seoulwww.boryung.co.krJi Hyun [email protected]
BoryungPharmaceuticals Co., Ltd.
Boryung Pharmaceutical Co., Ltd.
ProductsKanarb® (Fimasartan) Kanarb Combination
R&D Pipeline
Boryung Pharmaceutical has developed Kanarb®, ananti-hypertensive drug that has been approved by the KFDA as the 15th new drug. This is the new ARB devel-oped by Boryung and it was launched in Korea in 2011. By the end of 2013, this product is number one prescribed ARB with performance of USD 30 million in Korea. 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.
Until now, Boryung has successfully licensed-out Kanarb with Mexico and 12 other Latin countries, Brazil, Russia, and China and we are expecting first oversea launch in Mexico June of this year. Also we are under business licensing dis-cussions with Japan, USA, Europe, Australia etc.
Boryung is developing Kanarb combination drugsfor more severe patients who are suffering fromhypertension, hyperlipidemia, heart failure anddiabetic mellitus.
For Kanarb & “HTCZ combination drug”, named of BKC001 was launched in 2013 and we have also developed “Kanarb and CCB” combo, named of BKC0002. For CCB combination,
Phase III clinical trial is now on progress. In additionto these, we are also developing other KanarbCombination drugs as future innovative drug!
Category
NCE
IMD
Product RS PC PI PII PIII LaunchRGTheraputic Area
CV
AN
CNS
BKC 001
BKC 003
BKC 002
BKC 004
BSN 001
BCN 002BNT 002
BVN 001
BVN 002BVN 003
Biologics
O
O
O
O
O
O
O
O
O
O
6
Celltrion’s goal is to provide affordablealternatives 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 antibodybiosimilar.
We are using our accumulated R&Dtechnology and manufacturing capabilities to develop, manufacture & 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 ofadvanced biomedicines.
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 administra-tive 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-αantagonist market and is likely to be the only biosimilar product in the market for the next 4 to 5 years.
CEO:Address:
Website:Phone:Fax:E-mail:
JungJin SeoHead Office 13-6, Songdo-dong,Yeonsu-gu, Incheon,406-840, South Koreawww.celltrion.com+82-32-850-5008+82-32-850-5057contact@celltrion.com (business)[email protected] (investment)
Celltrion, Inc.
Celltrion’s Goal
Products
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)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 seasonalinfluenza viruses. Celltrion received IND approval from England’s Medicines and Healthcare products RegulatoryAgency (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 newantibody 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, ifsucceeded.
Additionally, Celltrion is developing innovative drug to cure rabies by collaborrating with the US Center for Disease Con-trol 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 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 driving force behind Celltrion’s future growth.
R&D Pipeline
7
CKD has focused on the research and development of New chemical entities(NCE), Incrementally modified drugs(IMDs) and Bio-pharmaceuticals. In the fields of NCE, Camtobell®was launched in 2004, as the first CKD new drug developed by its own technology. Based upon this successful experience, DuvieTM which is a thiazolidinedion derivative for type 2 diabetes has been approved by Ministry of Food and Drug Safety(MFDS) in 2013 and launched on February 2014.
Phase I clinical trials for CKD-516 (Tubulin inhibitor & VDA) and CKD-581 (Pan-HDAC inhibitor for cancer) are in prog-ress. In addition, CKD-732 (Fumagillin derivative) developed by CKD has been licensed to Zafgen and phase IIa clinical trials have been completed for severe obesity in Australia last year. Recently, CKD-732 confirmed positive results from clinical trials in patients with Prader-Willi syndrome. CKD-519 is a CETP inhibitor which increases HDL cholesterol being developed to treat dyslipidemia. It completed preclinical study and has been approved for Phase I clinical trials. 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 Bio-pharmaceuticals, CKD-11101, anti-anemia agent is a biosimilar of NESP® in Phase I clinical trialsand CKD-12201, Prophylactic vaccine forthe cervical cancer cause of human papilloma virus infection,has successfully completed Phase I clinical trials. 8
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 ofpharmaceutical industry in Korea for over 70 years since its inceptionin May 1941.
CEO:
Address:
Website:Phone:
E-mail:
Jung Woo Kim,Kyu Don KimLocation 8, Chungjeong-ro,Seodaemun-gu, Seoul, Koreawww.ckdpharm.comIndi Baik,Director Global Business Unit [email protected]
Chong Kun DangPharmaceutical Corp.
Chong Kun Dang Pharmaceutical Corp.
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 indus-try. 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. In R&D, CKD was the first company to establish a Research Institute in 1972 among Korean pharmaceutical companies. Through contin-uous 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.
Products
R&D Pipeline
9
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 first developed EPO[Epokine], ciprofloxacin injection[Citopcin] and simvastatin [Simvastar] pharma-ceutical products in Korea. Now, 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 Health-Care 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.
CEO:Address:
Website:Phone:
E-mail:
Dal won Kwak, Chul ha KimHead Office CJ CheilJedang Center, 330, Dongho-ro, Jung-gu,Seoul 100-400, Koreawww.cjp.co.krKwang Hee Hong, PhD, MBAHead Global Business [email protected]
CJ HealthCare Corporation
CJ Healthcare Corporation
1. Epokine (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 (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 (Vancomycin) - Vancorin®is the best choice for MRSA & MRSE.
4. Tapocin (Teicoplanin)- Tapocin®has excellent antibacterial effects on MRSA, MRSE and Enterococcus.
5. CONDITION (Hangover relief drink) - CONDITION®has launched in 1992 creating a new market of hangover relief drink in Korea.
6. HongSamJin Gold (Red Ginseng drink) - HongSamJin Gold® is anoutstanding energy drink produced with 6-yeared red ginseng.
7. HutGaeSoo (Thirst –quenching tea drink) - HutGaeSoo®contains the goodness of Hovenia dulcis with its function of liver protection.
Products
1. China -Vancomycin Inj., Teicoplanin Inj., CONDITION®
2. Japan -Cefozopran, Cefotiam, Cefmenoxime, Ceftriaxone Inj., Ceftazidime Inj.
3. Southeast Asia- EPO, G-CSF, Vancomycin Inj., Teicoplanin Inj., Ciprofloxacin Inj., Moxifloxacin Inj.,Ceftriaxone Inj., Ceftazidime Inj.
4. Africa - EPO, G-CSF
5. The Middle East - EPO, G-CSF, Vancomycin Inj., Levofloxacin Inj., Ciprofloxacin Inj., Ceftriaxone Inj.,Cefotaxime Inj., Ceftazidime Inj.
6. Latin America - EPO, G-CSF, Vancomycin Inj., Teicoplanin Inj.
Global Business
10
R&D Pipeline
Product Phase Therapeutic Area
Vogmet
CJ-12420
CJ-12406
CJ-12524
2nd Generation EPO
2nd hGH
Varicella-zoster virus Vaccine
CJ-30056
CJ-30059
CJ-30060
CJ-30049
Launched
PII
PI
Pre-clinical
PI
PI
Pre-clinical
P3
P2
P1
Approved
Diabetes
GERD, Licensed
H, pylori eradication, Licensed
Anti-cancer (Targeted treatment)
Anti-Anemia
Growth Hormone
Chicken Pox Vaccine
Anti-Diabete
Anti-hypertension
Anti-hypertension
Anti-cancer
11
Daewoong Pharmaceutical is the pharmaceuticalcompany 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
Lee, Jong WookHead Office 163-3, Samsung-dong,Kangnam-gu, Seoulwww.daewoong.comAlice Lee, ManagerConnect & [email protected]
CEO:Address:
Website:Phone:
E-mail:
Seong ho Jeon, General ManagerGlobal Strategy [email protected]
Daewoong Pharmaceutical Co., Ltd.
DaewoongPharmaceutical Co., Ltd.
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.
IMD (Incrementally Modified Drugs)
DescriptionMOACode Development StatusR MPre PI PII PIII
DWJ01
DWJ02
DWJ03
DWJ04
DWJ05
DWJ06
DWJ07
O
O
O
O
O
O
O
R&D PipelineNew Chemical Entities
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DescriptionMOACode Development StatusR MPre PI PII PIII
DWP05195
DWP09031
DWJ205
DWJ206
DWJ208
TRPV1 AntagonistAggregation Inhibitor
FungicidalAPA (Reversible)
Ion Channel Blocker
Neuropathic PainAlzheimer Program
Antifungal-Fungicidal ProgramAntiulcer Program
Cancer Pain, Low-Back Pain
O
O
O
O
O
Biologics
DescriptionMOACode Development StatusR MPre PI PII PIII
DWP431
DWP453
DWP401
DWJ1121
DWJ1142
DWP412
DWJ172
DWP143
DWP420
BMP-2
EGF
hGH
EPO
Botulinum toxin Type A
Dental sinus lifting graft
Spinal fusion device
Diabetic foot ulcer, spray type
Acute wound healing (OTC)
Oral mucositis, spray type
Lyophilized powder
Pen type injector + Liquid cartridge
Biosimilar, Recombinant Human Erythropoietin
Anti-wrinkles
O
O
O
O
O
O
O
O
O
5-HT4 Agonist
HMG CoA Reductase Inhibitor + Angiotensin2 Blocker
Acetylcholine EsteraseInhibitor
PDE-5 Inhibitor
PPI + Antibacterial
NK1 Blocker
HMG CoA Reductase Inhibitor + PPARa Agonist
GI Motility Enhancer, Sustained Release
Hyperlipidemia/Hypertension,Combination Drug
Alzheimer’s Disease, Patch
Erectile Dysfunction, Chewable Tablet
H.pylori, 3 Fixed Dose Combination
Antiemetic, Nano Delivery
Hyperlipidemia, 2 Fixed DoseCombination
Il-Sup, HuhLocation 107, Ihyeon-ro, 30 beon-gil, Giheung-gu, Yongin, 446-770, Koreawww.greencross.comH.G. Beak, Team [email protected]
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Green Cross Corporation (GCC) is an exemplary R&D-oriented pharmaceutical company that leads the bio-technolo-gy industry in Korea. This becomes clear acknowledging what GCC has achieved since its foundation in 1967.
GCC has pioneered in the field of biopharmaceuticals, such as vaccines, plasma derivatives, recombinant proteins, diagnostics and therapeutic antibodies. GCC has been well known for the R&D achievements over the years with commercialization of ‘HepavaxTM B’, the world’s best-selling Hepatitis B vaccine, ‘HantavaxTM’, the world’s first epidemic hemorrhagic fever vaccine, and ‘Varicella Vaccine-GCC inj.’, the world’s second chicken pox vaccine.
A complete flu vaccine pipeline includes Seasonal Influenza vaccine (GC FluTM), H1N1 vaccine, Avian Influenza vaccine and so on. GCC is also pursuing opportunities in rare diseases developing therapies for Hunter Syndrome (HunteraseTM), and Fabry disease. With continuous investment in R&D, its portfolio now includes gene/celltherapeutics and small molecule drugs. In 2013, GCC earned U$815 million in revenues recording it as the 2ndlargest Korean pharmaceutical company and invested U$74.4 million in R&D which is one of the largest in Korea.
Starting from the nation’s first Albumin production in 1971, GCC currently manufactures more than 12 plasma deriva-tives including Immunoglobulin, Anti-hemophilic factors, and Anti-thrombin factor. Recent developments include‘B-domain deleted recombinant Factor VIII (BDD rFVIII), GreenGene FTM’, a 3rd Generation of recombinant Factor VIII for Hemophilia A treatment.
GCC succeeded to develop the world’s third Hepatitis B vaccine in 1983, the world’s first epidemic hemorrhagic fever vaccine in 1988, and ‘Varicella Vaccine-GCC inj.’, the world’s second chicken pox vaccine. With the construction of our Hwasun plant, a vaccine-dedicated manufacturing plant, the seasonal influenza vaccine ‘GC FluTM’ became the fourth product in the world to obtain the Pre-Qual-ification (PQ) approval from the WHO.
Green Cross Corporation
Products
CEO:Address:
Website:Phone:
Fax:E-mail:
Green Cross Corporation
Hong-kwon Woo, Team [email protected]
Plasma Derivatives & Recombinants
Vaccines
R&D Pipeline
14
GCC has provided a broad range of ethical medicines for cardiovascular, cerebrovascular, hypertensive, & metabolic diseases. Along with our cataplasma products (one of our core OTC products), GCC also has provided OTC products in fields of respiratory, dermatology & immunology.
ETC & OTC Medicines
Indication R MANC IND PhI PhII PhIII NDA
Seasonal fluSeasonal flu (Cell culture)
Quadrivalent Influenza Vaccinefor Sesonal flu
AnthraxTetanus, diphteria
Tetanus, diphteria and pertussisHemophilia A
Hunter SyndromeInfectionsInfections
NeutropeniaFabry Disease
Anti0thromboticsCancer
Project
GCFLU™GC3106A
GC3110A
GC1119
GC2107
MG4101
GCPCG
GC1107
GC111A
GreenGene F™
Hunterase™
IVIG-SN™ 5%
IVIG-SN™ 10%
GC1109
US
US
US
US
15
HanAll BioPharma is a R&D-oriented pharmaceutical company, currently listed on the Korean Stock Exchange (KOSPI).
CEO:Address:
Website:Phone:
E-mail:
Dr. Sungwuk KimLocation 11-10,Sincheon-dong, Songpa-gu, Seoulwww.hanallbiopharma.comSoonim Lee, [email protected]
U.S. BranchHPI. Inc.9605 Medical CenterDrive, Suite #290Rockville, MD, 20850S.T. Oh, [email protected]
HanAll BioPharma Co. Ltd.
R&D Pipeline
HL156CAN
HL036
HL161
HL009
HL040
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 defeated AMPK signalingfunction and cytostatic effect in cancer cells with normal AMPK signaling function. HanAll has confirmed potential 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 current-ly marketed anti-TNF alpha products having larger molecular size. Furthermore, via protein engineering, HL036 will have greater affinity to allow smaller doses and increase the eficacy. It is anticipated that higher concentrations of HL036 will be found in targeted ocular areas when administered topically, preventingsystemic ADEs. HanAll aims to utilize unique property of HL036 for the indication of dry eyes bydeveloping ophtalmic 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 presents lysosomal degradation of IgG, thus contributing to a long half-life in the circulation. While FcRn mediated half-life 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)
InformationProduct
HL009, adenosylcobalamin liposomal gel, has three different potential mechanisms of actions for the treat-ment 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. Adenosyl-cobalamin 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.*KR Phase II (complete) / US Phase II (complete) (Aug 2013)
HL040, a fixed dose combination product, is composed of atorvastatin and losartan for the treatment of lyperlipidemia and hypertension. HanAll finished the phase I study, and currently conducting phase III trial in Korea and phase I study in US.*KR Phase III (in-progress) / US Phase I (complete) (Aug 2013)
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HANDOK (Chairman & CEO Young-Jin Kim), a leading innovation-driven pharmaceutical/health-care company in Ko-rea, develops, manufactures and distributes healthcare solutions to improve the health and quality of human life.
It was founded in 1954 and has been dedicated to developing and providing innovative pharmaceutical products (Pre-scription drugs & OTC drugs), medical devices, and in vitro diagnostics. Handok grew with its joint venture partner Hoechst/Aventis/Sanofi from 1964 to 2012. In several areas Handok has also established strategic collaborations with multiple multinational pharmaceutical companies. Handok ended its joint venture relationship with Sanofi in 2012. In 2013, Handok changed its company name from Handok Pharmaceutical Co., Ltd to Handok Inc. and declared its vision to become, “The Health Innovator” as Korea’s leading global healthcare company.
CEO:Address:
Website:Contact Person:
E-mail:
Kim YoungJinLocation 132, Teheran Street, Gangnamgu, 135-923, Seoulwww.handok.co.krSoHyun KwonHead of Licensing & Business Development [email protected]
Handok Inc.
Handok Inc.
Main Products
R&D Pipeline
is the first fixed dose combination of glimepiride and metformin HCl in Korea.is the combination with Sufonylurea + Metforminrecommended by global guideline.provides glycemic control with favorable safety profile.significantly reduces HbA1c compared to metformin.is superior to Metformin in FPG reduction.allowed more patients to achieve glycemictarget than Metformin.has been registered by 135 countries.
Amaryl M(Glimepiride + Metformin HCl)
is the first patented sustained-release fixed dose combination of glimepiride and metformin HCl. (Winner of Korea New Drug Award, 2009)was applied by DRM technology (Dual ReleaseMicro-coating Technology).one a day can improve patients’ compliance.has been registered by 33 countries.
Amaryl Mex(Glimepiride + Metformin HCl)
ProjectCode
LeadSelection
Candidate Selection
LeadOptimization Non-clinical Phase I Phase II Phase III
HL5171
HL5521
HL2351
HL2353
HL5201
HL5945
HL5501
Indication
Cancer
Glaucoma
Rheumatoid Arthritis/Orphan
Growth Hormone Deficiency
Diabetes/Obesity
Alopecia
Hemophilia
Diabetes
AMD
HL2356
HL1513 (IMD) BE study
17
CEO:Address:Website:
Gwan-Sun LeeLocation 14, Wiryeseong-daero, Songpa-gu, Seoul 138-724, Koreawww.hanmipharm.com
Christine LeeManager of Global
Business Development+82-2-410-8761
LICENSING OUT
Si-Young JungSenior Manager of
In-Licensing+82-2-410-9292
LICENSING IN
Sangjae LeeSenior Manager of
Export Business+82-2-410-9078
EXPORTINFORMATION MANAGEMENT
Kyoung Woo LeeLicensing Information
Manager+82-2-410-9291
Established in 1973, Hanmi Pharmaceuticals now is one of the top 5 pharmaceutical companies in terms of revenue and the most R&D focused company in Korea with the highest R&D investment for several years.
Hanmi has been successful for a few decades with high flexibility, continuously changing its market/development strat-egy from first generics to IMD &FDC (Incrementally Modified Drug and Fixed Dose Combination) to new drug develop-ment including innovative small molecules and biologics. During the period of significant changes, Hanmi made multiple strategic collaboration relationships with multinational companies and biotech companies.
As the only Asian company with significant presence both in Korea and China, as the most R&D focused company with number of clinical stage projects with competitiveness, and as the company with open innovation based on multiple de-velopment/marketing collaborations, Hanmi is trying to develop and provide differentiated treatment options to patients suffering from various disease.
Hanmi Pharmaceutical Co., Ltd.
R&D PipelineSmall Molecule Pipeline (as of Aug. 2013)
Category Candidates Characteristics Development Stage
Oncology
OraxolOratecan
HM781-36B
KX-01HM61713
Paclitaxel + HM30181AIrinotecan + HM30181AOrally active pan-Her inhibitorSrc kinase and tubulin dual inhibitorEG FR mutant selective inhibitor
Phase II Licensed out to Kines (US)Phase I Licensed out to Kines (US)Phase II (KR)Phase I (KR)Phase I (EU)
LAPSCOVERY (Long-acting Protein/Peptide Discovery Technology) Pipeline (as of Aug. 2013)
Candidates Characteristics Development Stage
LAPS-Exendin (HM11260C)LAPS-hGH (HM10560A)LAPS-GCSF (HM10460A)LAPS-EPO (HM10760A)LAPS-IFNα (HM10660A)LAPS-Insulin (HM12460A)
Long-acting Exendin-4 analogLong-acting hGHLong-acting G-CSF analogLong-acting EPOLong-acting IFNαLong-acting Insulin
Phase II (US)Phase II (EU)Phase II (US)Phase I (US)Phase I (MX)Phase I (US)
18
Fixed-dose Combination Pipeline (as of Aug. 2013)
Project Name Combination Development Stage
Amosartan®HCP0703
HCP0912
HCP1102
HCP0613
HCP1103
HCP1104
HCP0910
Amlodipine / LosartanPseudoephedrine / Levocetirizine
Irbesartan / AtorvastatinMontelukast / Levocetirizine
Mosapride / Bacillus subtilis / Streptococcas feaciumAmbroxol / Levodropropizine
Aceclofenac / EperisoneFluticason propionate / Salmeterol
Regulatory stage in ex-Korean territoriesPhase IIIPhase IIIPhase IIIPhase IIPhase IPhase IPhase I
19
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. has tried its utmost 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 60 mil. 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.
CEO:Address:
Website:
Phone:Fax:E-mail:
Dong Yeon, KimLocation IL-Yang Bldg. 544-5 Dogok-dong, Gangnam-gu, Seoulwww.ilyang.co.krSun Park, Ph.D.General Manager/Licensing [email protected]
Il-Yang Pharmaceutical Co., Ltd.
Il-Yang Pharmaceutical Co., Ltd.
Products
2nd generation Bcr-Abl tyrosine kinase inhibitor (TKI) for the treatment of Philadelphiachromosome positive (Ph(+)) CML.Indication: Ph(+) chronic myeloid leukemia (CML) in chronic phase (CP) or acceleratedphase (AP).Development stage: - CML-CP NDA approved in Korea by KFDA in 5th JAN, 2012. - Phase III for CML-CP has initiated in Korea, Thailand, India, and Philippines.Key features - No serious side effect, Early efficacysignals higher than initial MCyR response at 6 month.
Supect (API: Radotinib)
14th New Drug developed in KoreaNoltec is a Proton PumpInhibitor that controls the secretion of gastric acid for the treatment of GU, DU, GERD/EE, and NERDGreater effect on Severe GERD patients, lowreoccurrence, no symptoms of night time heartburn, and low DDI.
Noltec (API: Ilaprazole)
R&D Pipeline
20
has been announced at American Society for Virology on 22 July, 2012 that it is 20~30 times potent than Tamiflu.
Anti-Viral agent IY 5741
Ilaprazole
GU / DU
EE / GERD
NERD
CML-CP
CML-CP
Virology
Korea, China
Korea
USA
IY5741
Vaccine
Korea
Multi national
Multi nationalRadotinib
Virology
Compound Application Country Ph I Ph II Ph III NDA Marketed
ongoing
ongoing
21
1) ISU ABXIS’ Innovative Model “Shift from orphan drug-specialized company to a globalbiotechnology company”
2) Specialized sector: Therapeutic biological drug development (Including enzyme pharmaceutical drug)A. Experience on the full process of development from preclinical phase to marketing phaseB. Focus on the development of novel anticancer antibody drug and blockbuster biosimilar drugC. Specialized technology - Antibody screening technology - Efficacy verification - Therapeutic antibody production - Clinical Development - GMP facility approved by 7 different countries including Korea
3) Differential business model A. Global licensing in early development phase B. Full experience in ERT development : Orphan drugsC. Development for the next generation blockbuster biosimilar drugs D. Business focus on the BRIC market
ISU Abxis Co., Ltd.
Company Profile Products
Product Name
Clotinab® (Antiplatelet antibody, Abciximab)
Abcertin®(Recombinant enzyme protein, Imiglucerase)
Fabagal®(Recombinant enzyme protein, Agalsidase beta)
a. The world’s second Abciximab b. GPIIb/ IIIa receptor antagonists/ anti-thrombotics c. Binds to the glycoprotein (GP) IIb/IIIa receptor of human platelets and inhibits platelet aggregation d. Indication: Adjunct to PCI (Percutaneous coronary interventions)
a. The world’s second Imiglucerase b. Recombinant human glucoserebrosidases for enzyme replacement therapy (ERT) c. Designated as orphan drugd. Indication: ERT for Gaucher’s disease
a. The world’s second Agalsidase betab. Recombinant human alpha-galactosidase for enzyme replacement therapy (ERT)c. Designated as orphan drugd. Indication: ERT for Fabry’s disease
Product Profile
CEO:Address:
Website:
Phone:Fax:E-mail:
Daeseong KimGlobal R&D Center, Bldg. C, 5th Floor,22, Daewangpangyo-ro 712 Beon-gil,Bundag-gu, Seongnam-si, Gyeonggi-do,463-400 Koreawww.abxis.comHyouna Yoo, Senior [email protected]
R&D Pipeline
Product Indication
Antibody
Enzyme
Antibody
Enzyme
Enzyme
Antibody
Antibody
Product
Lead Dev
Process Dev
Launched (2007)
Launched (2012)
Launched (2014)
Preclinical
Process Dev
Status
Metastatic
Hemophilia B
Anti-coagulent
Gaucher disease
Fabry disease
Breast cancer
Rheumatoid Arthritis
ISU104
ISU304
Clotinab®
Abcertin®
Fabagal®
ISU103
ISU202
Novel Drugs
Orphan Drugs
Bio-similars
22
CEO:Address:
Website:
Kyung Ha Lee2477, Nambusunhwan-ro, Seocho-gu, Seoul, Koreawww.jw-pharma.co.kr
BUSINESS DEVELOPMENT (LICENSING)
Daekyung KohProduct Development
and Planning+82-2-840-6857
EXPORT (APIs/FINISHED PRODUCTS/CMO BUSINESS)
Ji Yong ParkChief of Int’l Sales Team -1
Global Business Division+82-2-840-6774~6
CORPORATERESEARCH PLANNING
Sung Hwa SonCorporate Research and Development+82-2-840-6935
Major Export Products
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, antibiotic, cardiovascular, gastrointestinal, nephrology/antianaemic, anticancer, diabetes, gout and neurosychiatry.
JW Pharmaceutical Co., Ltd.
Type Product Group
Finished Product
API(Active Pharmaceutical Ingredient)
1. Carbapenem Antibiotics2. Amino Acid Solutions3. General I.V. Solutions & Other Sterile Solutions4. Anticancer Agents5. Antimicrobial & Antifungal Agents6. Gastrointestinal Agents7. Topical8. Multivitamins9. Agents for Antibiotics10. Miscellaneous
1. Carbapenem Antibiotics: Inipenem/Cilastatin, Meropenem2. Anti-fungals: Ketoconazole, Itraconazole, Fluconazole3. Chiral Products for Custom Synthesis & Specialty Amino Acid4. Miscellaneous
23
R&D Pipeline
JW is focusing on developing Biologics as well as Small molecules in the areas of oncology, endocrinology andimmunology by employing itsnovel platforms.
URGO Hilmogel
WINUF Injection
URC102
THRUPAS® ODT
ZEPEED®
CreaVax RCC®
CreaVax HCC®
CreaVax BC®
CreaVax RA®
Actemra®
Actemra® SC
Dia-M™
Livasartan™
URGO Dressing
Guardlet®
THRUPAS® Tad
NCE
NBE
Fixed-dosecombination
Other
Category Product DS PC NDA MKTPIIIPIIPI
Clinical Trials
CWP291
Wound Healing
Total Parental Nutrition
Gout
Prostatism
Erectile Dysfunction
Oncology
Oncology
Oncology
RA
RA
RA
Mitiglinide/Metformin
Pitavastain/Valsartan
Wound Healing
Diabets
Prostatism
Indication
Oncology
Oncology
Pipeline represents progress of R&D programs since 2010CreaVax RCC® was approved as pharmaceuticals for export
URGO Hilmogel
WINUF Injection
URC102
THRUPAS® ODT
ZEPEED®
CreaVax RCC®
CreaVax HCC®
CreaVax BC®
CreaVax RA®
Actemra®
Actemra® SC
Dia-M™
Livasartan™
URGO Dressing
Guardlet®
THRUPAS® Tad
NCE
NBE
Fixed-dosecombination
Other
Category Product DS PC NDA MKTPIIIPIIPI
Clinical Trials
CWP291
Wound Healing
Total Parental Nutrition
Gout
Prostatism
Erectile Dysfunction
Oncology
Oncology
Oncology
RA
RA
RA
Mitiglinide/Metformin
Pitavastain/Valsartan
Wound Healing
Diabets
Prostatism
Indication
Oncology
Oncology
24
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 onlyUS FDA approved novel chemical drug, as well as Valtropin®, the first 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.
CEO:Address:
Website:Phone:
E-mail:
Il-Jae JungLG Gwanghwamun Bldg.92, Sinmunno-2ga, Jongno-gu, Seoul, Koreawww.lgls.comJong-heon Won, ManagerBusiness Development Team [email protected]
LG Life Sciences, Ltd.
LG Life Sciences, Ltd.
Products
Fast Active, the most potent quinoloneantibiotic in the world, commercialized in over 30 countries worldwide.
Factive®
The right choice for managing short stature recombinant human growth hormone with proven efficacy and safety since 1993.
Eutropin®
Human recombinant erythropoietin, safe and effective treatment for anemia of chronicrenal failure.
Espogen®
Recombinant FSH, used in the treatment of female infertility in controlled ovarian hyperstimulation to induce the development of multiple follicles in a medically assisted reproduction program as well as an ovulation.
Follitrope®
High molecular weight hyaluronic acid visco supplement made by microbial fermentation for low side-effect, quality proven by EMEA and CE marking.
Hyruan Plus®
A novel dipeptidyl peptidase IV (DPP IV) inhibitor for T2DM with good efficacy and safety profiles.Approved by the KFDA in June, 2012.
Zemiglo®
SR-hGH - The world’s first once-a-week human growth hormone, US NDA has been filed for adult and multinational phase III trials are finished for pediatric GHD.Monoclonal Antibody Biosimilars - Enbrel, Humira and Avastin biosimilars are undergoing active development.
R&D Pipeline
25
1) Chemicals
NCE
IMD*
Class Product Indication DS PC NDAPIIIPIIPI
Clinical Trials
LC280126
LC350189
LC51SPA
LC52CIS
LC54AID3
LC53LE0H
ZB Combi
VR Combi
ZemiMet
ZemiSU
ZemiStatin
ZemiARB
Myocardial Infaction
Hyperuricemia, Gout
Multiple Sclerosis
Type 2 Diabetes
Metabolic Disease
Multiple Myeloma
Hypertension
Hypertension/Hyperlipidemia
Type 2 Diabetes
Type 2 Diabetes
Diabetes / Hyperlipidemia
Diabetes / Hypertension
o
o
o
o
o
o
o
o
o
o
o
o
*IMD = Incrementally modified drugs
2) Biologics
Biobetter
Biosimilar
Vaccine
HA-basedproduct
Class Product Indication DS PC NDAPIIIPIIPI
Clinical Trials
LB03002
LBEC0101
LBAL
LBDP
LBBZ
DTwP-HepB-Hib (liquid)
LBFL0101
LBVC
LBVD
LBVE
LBSA0103
YVOIRE contour plus
GHD (global)
Rheumatoid Arthritis
Rheumatoid Arthritis
Anemia
Colorectal Cancer
D/T/P/HBV/M
Influenza
Poliomyelitis
D/T/P/HBV/M/IPV
Pneumonia
Osteoarthritis
Soft Tissue Augmentation
o
o
o
o
o
o
o
o
o
o
o
SK Biopharmaceuticals focuses on discovery and development of new drugs as well as providing custom services for the manufacture and sales of active pharmaceutical ingredients and intermediates of drugs for major companies, in the factories that have been newly approved in Korea for current Good Manufacturing Practices of active pharmaceutical ingredients.
SK Biopharmaceuticals, through its affiliate SK Life Science, leads all Korean pharmaceutical companies with 14 autho-rized INDs in the US. SK Biopharmaceuticals has a preclinical research and development center located in Daejeon, South Korea, and SK Life Science, its business development and clinical research center in New Jersey, for the clinical devel-opment of its assets in the areas of epilepsy, irritable bowel syndrome, Parkinson’s disease, and cognitive impairment associated with schizophrenia.
The Custom Manufacturing Service Business manufactures active pharmaceutical ingredients for other pharmaceutical company customers. These customers have recognized the quality of the products, the operational efficiency provided by the Korean FDA-approved manufacturing facility in Daejeon, Korea, and technologies proprietary to SK Biopharma-ceuticals, such as continuous flow synthesis, low temperature reactions, and catalytic conversions that differentiate the company from other chemical suppliers.
CEO:
Address:
Website:Phone:
E-mail:
Christopher C. Gallen M.D., Ph.D.99 Seorin-dong, Jongro-gu,Seoul 110-110, Koreawww.skbp.comHaein ShinTeam Leader, Business Development [email protected]
SK Biopharmaceuticals
SK Biopharmaceuticals
R&D Pipeline
Products Indications Development Stage
Diazepam Nasal SprayCarisbamate (YKP509)
SKL-N05
YKP3089YKP10811SKL-PDSKL-A4RSKL-PSY
SKL-ADHDEpilepsy Project
Pain ProjectSchizophrenia Project
HD Project
Acute Repetitive SeizuresEpilepsy, Infantile SpasmNarcolepsy, Obstructive Sleep Apnea, Attention DeficitHyperactivity DisorderEpilepsy, Neuropathic Pain, Bipolar DisorderChronic Constipation, Irritable Bowel SyndromeParkinson’s Disease, NeuroprotectionCognitive Impairment Associated with SchizophreniaBipolar DisorderAttention Deficit Hyperactivity DisorderEpilepsyNeuropathic PainSchizophreniaHuntington’s Disease
NDAPhase IIIPhase III
Phase IIPhase IIPhase IPhase I
PreclinicalPreclinicalDiscoveryDiscoveryDiscoveryDiscovery 26
Product Information
NCE 401(RIF, Radio-infuced Fibrosis agent) New Chemical Entity, In preclinical study
NCE 402(Type 2 diabetes agent) New Chemical Entity, In preclinical study at USA
NCE 403(BPH, Benign prostatic hyperplasia agent) New Chemical Entity, In preclinical study at USA
NCE 601(anti-Heamophilia agent,4th generation Factor VIII)
Bio-Better, in Clinical study at USA with CSL
SID 710(anti-dementia patch, Rivastigmine) IMD, in Registration at EU
SID 820(anti-gastric ulcer agent,Esomeprzole freebase)
IMD, in Registration at EU
27
The life science business of SK Chemicals contributes to the enhanced health and life quality of mankind by developing new synthetic and drugs, including SUNPLA® - Korea’s first new drug, vaccines, innovative production technologies, and combining IT technologies withhealthcare services.
SK Chemicals focuses on developing new chemical entities, herbal and biopharmaceutical drugs in therapeutic areas with high unmet medical needs.
SK Chemicals Co., Ltd.
CEO:Address:
Website:Phone:
E-mail:
Chang Geun, Kim686, Sampyeong-dong, Bundang-gu, Seongman-si, Gyeonggi-do,463-400 Koreawww.skchemicals.comSojin, JungAssociate Research Scientist [email protected]
SK Chemicals Co., Ltd.
R&D Pipeline
ViroMed Co., Ltd. (KOSDAQ, 084990) is a leading biotechnology company located in Seoul, Korea founded in 1996 with a US presence doing business as VM BioPharma in Atlanta. The company has two main areas of focus: DNA/protein-based biopharmaceuticals and phytotherapeutics (botanical drugs/nutraceuticals). ViroMed now has six main products in its pipeline targeting cardiovascular disease, cancer, and immune-related disorder, with clinical trials being conducted in the US, Korea, and China.
CEO:Address:
Website:Contact Person:
E-mail:
Kim YongsooBldg 203, Seoul National University,#599 Gwanak-ro, Gwanak-gu, Seoulwww.viromed21.comYoungtae HongSection Chief,Strategic Business Development [email protected]
ViroMed Co., Ltd.
Viromed Co., Ltd.
Main Products
Product Target Disease Development Stage
VM202-PAD
VM202-DPN
Critical Limb Ischemia
Diabetic Peripheral Neuropathy
Plasmid DNA
Plasmid DNA
USA/Korea
USA
China
Korea
Phase III (completed)
Phase II (ongoing)
VM202-ALS Amytrophic Lateral Sclerosis Plasmid DNA USA Phase I/II (ongoing)
VM202-CAD
VM206
VM501
Coronary Artery Disease
Breast Cancer
Chemotherapy-InducedThrombocytopenia
Plasmid DNA + Catheter
Plasmid DNA + Virus
Recombinant Protein
Korea
Korea
China
Phase II (planned)
Phase I (completed)
Phase III (ongoing)
Phase II (ongoing)
Technology Country
28
VM202 is a DNA-based medicine for the treatment of ischemic cardiovascular diseases via therapeutic angiogene-sis. It is designed to express isoforms of hepatocyte growth factor (HGF) for the treatment of coronary artery disease (VM202-CAD) and peripheral artery disease (VM202-PAD) by the formation of new blood vessels when injected into the ischemic sites. These new collateral vessels will increase blood flow and tissue perfusion, thereby effectively treat-ing ischemia. VM202 has also been shown to stimulate the growth and regeneration of nerve cells. Therefore, it is also being developed for the treatment of diabetic neuropathy (VM202-DPN), a common complication of type 2 diabetes mellitus that usually manifests itself as a disease affecting the nerves in the leg, causing intense pain and difficulty in movement. VM202 target indication has expanded to include amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. Lou Gehrig’s disease is a rare neurodegenerative disease that has no effective treatment available. For VM202 to enter the global market, the company is carrying out multinational late stage clinical trials in the US, China, and Korea.
VM501 is a re-engineered form of interleukin 11(IL-11) targeting chemotherapy-induced thrombocytopenia(CIT). It has been shown to induce an increase in the number of blood platelets. In Phase I and Phase II clinicaltrials performed in China, significant therapeutic effects were shown without severe adverse effects.
Phase III clinical trial is currently ongoing in China.
VM206 is a therapeutic cancer vaccine that has potential applications for breast, ovarian, and pancreatic cancers. Phase I clinical trial has been completed in Korea with its results being prepared to be published in an international scientific journal.
VM202 – DNA Therapeutics Inducing Angiogenesis and Nerve Regeneration
VM501 – Protein Therapeutics for Thrombocytopenia
VM206 – Therapeutic Cancer Vaccine
29
Main Products
30
CEO:Address:
Website:Phone: Fax:
Yoon Searb, Kim49-6, Daebang-dong, Dongjak-gu,Seoul, 156-754, Koreawww.yuhan.co.kr+82-2-828-0181+82-2-828-0300
Yuhan Corporation
Yuhan Corporation
R&D Pipeline
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:
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 worldwide to markets in India and Southeast Asia. Yuhan is continuously expanding its overseas markets with finished products.
New drug development projects with multinational partners. Developing and optimizing cost effective synthetic processes for APIs and intermediates.
Product Indication Pre-clinical LaunchingP1 P2 P3Gastrointestinal Disorder
Metabolic Disorder
Cardiovascular Disorder
Immunology / Inflammation
Oncology
Other
YH4808 (K+ -competitive acid blocker)
YH_Bio1
YH 14617
YH 16410 (Fixed Dose Combination)
YH_Chem3 (LXR modulator)
YH1177 (Fixed Dose Combination)
YH1176 (Fixed Dose Combination)
YHB1411-2 (Anti-TNFα antibody)
YH14618 (TGFβ modulator)
YH14619 (TGFβ modulator)
YH_Chem1 (GPR119 agonist)
YH 14755 (Fixed Dose Combination)
YH 14700 (Fixed Dose Combination)
YH_Chem2
YH_Herb
YH_Chem4
YH_Bio2
YHD1023
YH_Chem5
YHD001YHD14642
YHD14810
YH12852 (5-HT4 agonist)
GERD / NSAIDs induced GI injury
Diabetes
Diabetes
Hypertension / Hyperlipidemia
Atherosclerosis
Otitis mediaOtitis media
Rheumatoid ArthritisDegenerative disc diseaseOsteoarthritic disease
Diabetes
Hyperlipidemia / Diabetes
Hypertension / Hyperlipidemia
Diabetes
Tinnitus
COPD
Cancer
Erectile dysfunction
Cancer
AsthmaPeriodontitis
Cancer
IBS-C / Chronic constipationP2 initiated
Pre-clinical
P2 initiated
Pre-clinical
Pre-clinical
Pre-clinical
Pre-clinical
P1 on-going
P1 / 2a on-going
Pre-clinical
Pre-clinical
Pre-clinical
P3 on-going
Pre-clinical
Pre-clinical
Pre-clinical
Pre-clinical
P2
Pre-clinical
P2
P2
Pre-clinical
Pre-clinical
9-10 June 2015 | Seoul, South Korea
The ONLY and MOST Targeted Biologics and Bio-similars Focused Platform in Korea!
Meet top minds from over 100 key players in Korean biologics industry at:
For further assistance, please contact:
Amber Liang
E: [email protected] | T: +65 6493 1871
VISIT OUR WEBSITE TODAY:http://www.imapac.com/business_conference/biologics-world-korea-2015/