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Cross- Cross-Border R&D in Border R&D in China China - - PDF document
Cross- Cross-Border R&D in Border R&D in China China - - PDF document
1 2 Cross- Cross-Border R&D in Border R&D in China China Und Understand rstanding ing the Reg e Regulat latory ry Ch Challenges allenges 1 Pane Panelists lists Moderator: Paul A. Ste ul A. Stewar art, t,
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China H China Healthcare Ma althcare Market rket Up Update date
SYNERGENICS
Jimmy Z. Zhang, PhD, MBA
CH CHINA OUTL INA OUTLOO OOK
7th largest pharmaceutical market in 2005, 5th largest
in 2008 ($25B), 3rd largest by 2013 ($73B), and largest by 2050
3rd largest single-country medical device market
– $2.3B IVD in 2010
Largest market by population
– Total population 1.34B (mainland, 2010), 5.84% over 2000 – Dramatically shifting demographics:
Sources: IMS, National Bureau of Statistics, industry publications
- > 60 yr: 13.26% ( 2.93%)
- < 14 yr: 16.60% ( 6.29%)
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Sources: Chinese Department of statistics & MOH, BEA database, Piper Jaffray estimates
0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 12.0% 14.0% 16.0% 18.0% 20.0% $0.0 $500.0 $1,000.0 $1,500.0 $2,000.0 $2,500.0 $3,000.0 $3,500.0 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010E2011E 2020E
China Healthcare Spending (US$ Billion) US Healthcare Spending (US $ Billion) China Healthcare As % GDP US Healthcare As % GDP
US: CAGR 2.5% China: CAGR 10%
Tota Total H Healthcar thcare Expen Expenditur itures i es in Chin China Is Is Low, Low, Bu But Gr t Growi
- wing Fa
g Fast st
CAGR 8.0%
Per Capita: $7,381 Per Capita: $183
Chin China a He Healthc althcare re Refo Reform (2009 (2009-11)
- 11)
– RMB 850 MB 850B
Objec Objectives: ives:
To expand basic medical insurance programs including:
– to insure 90% of its population by 2011 – to increase government insurance subsidy RMB120/person from RMB20- 40/person
To improve healthcare service infrastructure in grassroots
medical facilities (RMB100 billion)
To establish essential drug list (EDL) and its distribution system To promote public medical service equity and establish a nation-
wide standard "health record" for the entire population
To reform public hospitals (2011 nation-wide implementation):
separation of pharmacies from hospitals
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Sources: McKinsey & Company, CHIC 2011 presentation
- Improve R&D capability and encourage development of innovative drugs
- Enhance international footprint
- Strengthen medicine quality assurance system and technology
- Support transformation of leading local pharmaceutical companies
Central government funding for biomedical
USD in millions
12th 5-year plan goal 31 125 936 6,070 1,000 2,000 3,000 4,000 5,000 6,000 7,000 9th Five (1996-2000) 10th Five (2001-2005) 11th Five (2006-2010) 12th Five (2011-2015)
7.5 × 4.0 × 6.5 ×
Ch China 12th 5-Ye ina 12th 5-Year Plan ar Plan
Chi China Is a Is Refo form rming Intellectua g Intellectual l Pro Property Law ty Laws
- Third Patent Law Amendment: One Step Closer To International Standard
(effect on October 1, 2009)
– adoption of an “absolute novelty bar” – definition of “invention made in China”
- From “Copied In China”…
– new chemical entities (NCEs) not protected until 1993
- …To “Engineered In China”…
– “doing the same things cheaper and better,”
- …To “Invented In China”
- Major Differences between China and US Patent Laws
First to file No one year grace period on publication No patents on methods of treatment No CAFC (Court of Appeals for the Federal Circuit) No case law
Sources: Piper Jaffray; SIPO
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LINQ Pharmaceuticals LINQ Pharmaceuticals
Sofie Qiao, Ph.D. Sofie Qiao, Ph.D.
LI LINQ Pharmaceu NQ Pharmaceuticals icals
Mission – to deliver best-in-class small molecule
therapeutics cost-effectively and great shareholder returns time-efficiently
Strategy – trans-Pacific approach
– Optimally accessing resources/capabilities in Asia and the US – Focused on best-in-class programs
Team – experienced co-founders
– Sofie Qiao, Ph.D. – Kewen Jin, M.D.
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LEA LEAD Reca Recap
Vision - Turn drug discovery NPV positive Mission – Generate best-in-class and differentiated drug
candidates
Strategy – Headquartered in Bay Area with a small office in
Shanghai, utilizing Chinese CRO capabilities to conduct small molecule discovery against validated targets for which the scientific team have unique insight
Execution – Team with a business plan decided on 2 initial
targets (i.e. no licensing) to conduct patent-busting chemistry- driven discovery
Result – Raised Series A of $17 million, generated 2 preIND
candidates (cancer and antibiotics) in 2 years, and acquired by BioMarin in less than 3 years for up to $97 million
LI LINQ – – LEAD 2.0 EAD 2.0
Improve Capital Efficiency
– Smaller team and entirely virtual
Expand Asia Exposure
– Fundraising in China as well as US – PreIND deal-making possibly in Asia
Refine Target Selection
– Focus on therapeutic areas with huge global potential – Select targets which are recently validated
Create more value