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SK holdings SK Chemicals
Life Science Biz Life Science Division
Revenue: $ 848 MMEmployee > 300
Revenue: $ 1.2 B.Employee > 1,150
Life Science Business is outset for the growth drive in the future
Life Science in SK Group
SK Group
1) E&P: Exploration & Production
Holding company in SK Croup Fine Chemicals,
Life Science
New Drug Development
Custom Manufacturing Service
Drug development & Marketing
(Korean and Asian Market)
3
As of July 1st 2007, SK Corporation was divided into two companies, SK Energy and SK Holdings Ltd, and Life Science biz becomes a part of SK Holdings
Previous Structure New Structure
•SK Corporation had various operating divisions and held many subsidiary companies
•Reorganize as a holding company and 8 operating companies
•SK Life Science stays with holding company as one operating division
SK Corp.
SKTelecom
SKNetworks
OtherSubsidiaries
SK Holdings
SKTelecom
SKNetworks
OtherSubsidiaries
Purpose ofReorganization
Maximizing Management Efficiency Enhancing OverallShareholder Value
Solidifying Corporate Governance
Resolving the Issue of Under-valuation
SKEnergy
Life Science
Oil Refinery
E&P Lubri-cants
Chemicals
Life Science
SK Life Science
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SK Life Science Biz.SK Life Science Biz.
Organization
* CMS: Custom Manufacturing Service
Discovery Lab.
Drug Preclinical Research Lab.
R&D Planning Team
New Jersey R&D Center
Shanghai R&D Center
Life Science Strategy Team
Process R&D Lab.
CMS Production Team
Marketing Team(New Jersey)
Seoul, Korea
Daejeon, Korea
Shanghai, China
New Jersey, USA
CMS Business(CMS 사업부 )
Drug Development Center( 신약개발사업부 )
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KOREA
[Seoul]
Strategic Planning Licensing Out
[LSRDP 1)]
R&D Planning Licensing In Drug Discovery Early Preclinical Stud-ies Formulation Studies Intellectual Properties
USA
[New Jersey]
Advanced Preclinical Studies Clinical Studies in USA Regulatory Affairs in USA
CHINA
[Shanghai]
Drug discovery Market research in China
1) LSRDP: Life Science R&D Park
Drug Development Center
Role & Responsibility
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1993
1996 1998
1999 2000
Start Pharmaceutical re-search in New Jersey, US and Daejeon, Korea focus-ing on CNS area
IND Approval for YKP10A,an antidepressant, from U.S. FDA
IND Approval for YKP509,an anticonvulsant, from U.S. FDA
Licensing Out to J&J (YKP10A)
Licensing Outto J&J (YKP509)
IND Approval for YKP1358,an Antipsychotic, from U.S. FDA
2003 2005
IND Approval for YKP3089,an anxiolytic, from U.S. FDA(currently at POC entering)
Establish Shanghai Drug Dev. Center
2002
The first Korean company to obtain IND approval from U.S. FDA
Licensing Out to Johnson & Johnson (CNS field)
Developing globally competitive new drug pipeline
2007
New IND expected
History
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• Neuropathic Pain• Parkinson
Metabolicdiseases
CNS
• Obesity• Diabetes
• Epilepsy• Depression• Schizophrenia
DDS
• Transdermal• Controlled release• Intranasal Technology
R&D Areas
Successful track records in CNS drug discovery• Epilepsy, Depression, Schizophrenia, Neuropathic pain and Parkinson etc.
Expansion toward Metabolic diseases• Obesity, Diabetes and Osteoporosis
CV • Restenosis
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DDS
Pipeline Status
Metabolic
CV
CNS By J&J
Compound for DES
Obesity
Diazepam Nasal spray
Pain (target based)
Parkinson Disease
Schizophrenia/Anxiety
Depression(SNDRI)
IBS
Neuropathic Pain
Schizophrenia (YKP1358)
Epilepsy/Anxiety/NP (YKP3089)
Depression (YKP10A)
Epilepsy(YKP509)
Planning IND & Phase I in 2008
Discov-ery
Lead Preclini-cal
Phase I Phase II Phase III
Partnering Alliance- Clinical Study expected in May, 2008
Narcolepsy, Drug addiction (Ready to IND)
on-going Preclinical studies w/ active enantiomer (YKP1447)
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KOREA
[Seoul]
Planning
[LSRDP 1)]
Production
Process Development
QC/QA
USA
[New Jersey]
Marketing
Market Research
Customer Relationship
CHINA
[Shanghai]
Process Development
Biz Development
Raw Material Purchasing
CMS Business
Role & Responsibility
1) LSRDP: Life Science R&D Park
121) GMP (Good Manufacturing Practice)
Overview
Customers•Global Major Pharmaceutical Companies Pfizer, Roche, Bristol-Meyers-Squibb, Schering Plough, Novartis, GSK, J&J, etc.
Technology•Catalytic Processes, Continuous Reaction Technologies•Enzymatic technology•Conventional Organic Synthesis
Products & Services
•GMP Intermediates and API (End of 2007)•Process development and DMF support for customers
– Catalytic and Continuous Processes– Co-Work and DMF support
History & Location
•Operation since 2000 based on R&D capabilities•Production Plants and R&D in Daejeon, Korea•Marketing in NJ, USA
SK CMS provides custom manufacturing service to the global major pharma companies based on the innovative technological and production capabilities with a cGMP complied quality system
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Quality System
Plant Operation based upon cGMP & ICH Q7A
• Quality Management System
• Material Control System
• Facilities & Equipment System
• Production & In-Process Control System
• Laboratory Control System
Quality Assurance based on Quality Management Systems
• ’98 ~’01 GSK• ’02 ~’03 Roche, Novartis, Pfizer• ’04 ~’05 Pfizer, GSK, BMS, Lonza• ’06 Pfizer, BMS (Approved for cGMP Intermediate Production)• Current Preparation of API Production and DMF Filing for New Drug
Audits and Approval by Many Customers
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`08 년 하반기 신입 사원 채용
모집분야 주요업무 모집인원
Process Chemist
• 유기합성 기술을 활용한 신약 후보물질 및 관련 중간체 제조 공정 개발 연구 0 명
Process Engi-neer
• 신규 촉매 개발 , 신규 연속공정 개발 업무 0 명
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