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1、全球医药产业研究与发展的最新趋势 胡江滨 美中药协 (SAPA) 北京, 2004,1,报告内容,全球制药界新药开发最新概况 新药开发值得注意的走向 Project in-licensing 项目引进 Life Cycle Management (LCM) 产品周期的管理 Outsourcing What Why and (How) ?,2,Source: Sales data for 1992-2001 supplied by IMS Health,全球药品销售 1992-2003p,3,全球研发费用,全球新药上市,研发时间 (3 year moving average),全球销售,全球销售
2、，研发费用及研发时间和新药上市1992-2002p,4,Research,Late Development,Early Development,Regulatory assessment,Commercial-isation,Pre-clinical evaluation,Clinical evaluation,2.9yrs,1.5yrs,5.7yrs,US FDA: 1.0 yrs EMEA: 1.3 yrs Japanese MHLW: 1.4 yrs,Duration (median),Attrition (Number of compounds entering stage per c
3、ompound launched),9,1,1,新药 R annual reports; Pharmaprojects database; literature search; McKinsey analysis,13,Why License in/ Partnering,To complement in-house R+D efforts 对公司本身R& D 的补充 To hedge against unexpected product failure or disappointing commercial performance 以防不可预期的产品失败或者不佳的商业业绩 Increasin
4、g value of development and marketed products through arrangements with third parties 联和开发和销售,14,项目引进包括哪些方面,In-licensing/Partnering for global development 项目引进与联合开发 Discovery/Research Platform collaborations 研究平台的合作 New drug delivery technologies 新的给药剂型 Co-marketing, co-promotion 联合销售 Manufacturing r
5、elationships,15,项目引进案例 1999-2002,16,Competitors for a given licensing deal,Percent of respondents,Competition for Deals Is Also Increasing,5 years ago,Today,Source: McKinsey survey,17,Cross Functional Deal Team,Standard Processes and Team Work,Research and Development,Marketing,Legal,Finance,Patent,
6、18,Due Diligence,Obtain and review source documentation to provide a reliable evaluation of the: Scientific rationale Preclinical Safety Drug metabolism and pharmacokinetics Chemical and pharmaceutical development Clinical efficacy and safety Regulatory filability Patent status,19,Large Number of Op
7、portunities Evaluated for Every Deal Closed,110 Contacts 65 Early Assessments 17 Initial Evaluations 9 Due Diligences 3 Neogtiations 1 Deal Closed,20,New Trends in Drug Development目前的新走向,Now the classic drug discovery model is supplemented by传统的新药开发模式由下面两种方式进行补充 Project in-licensing 项目引进 Life Cycle
8、Management (LCM) 产品周期的管理 Outsourcing,21,Augmentin Claritin Zestril,Neurontin Flovent Cipro-floxacin,Procrit Lovenox Duragesic Diflucan,Zocor Pravachol Zithromax Zoloft,Actos Ambien Paxil Neupogen,Norvasc Fosamax Effexor Risperdal,Serevent Levaquin Aciphex,Prevackl Celicept Topamax,Gemzar Aricept Sin
9、gulair Advair/ Seretide,*Only drugs with revenues of more than US $100 million per year are included.,Why Life Cycle Management ?今后十年内专利过期的新药,22,Life Cycle Management,include Prolonged/Modified release dosage forms Fixed combination with other drugs Enhanced bioavailability New drug delivery princip
10、les Targeted or site-specific drug delivery,23,Global Drug Delivery Market, 2001,Total Drug Delivery Systems Market = $42.9 billions,Oral,Inhalation,Transdermal,Parenteral,Other,Total Pharmaceutical Market = $350 billions,24,各大公司用于LCM方面的研发费用,25,Success Story of LCM,The Cardizem Story,26,Wellbutrin:
11、Growth of a Blockbuster,$million,NCE exclusivity expires: 2004 PK half-life: 21 hours 8 days to reach steady-state plasma level,Wellbutrin (buproprion HCl) Story (GSK),Wellbtrin SR introduced,Wellbtrin XL approved,27,Why Develop Fixed Combination Products?,New patent protection Synergistic effects B
12、etter therapy Patient compliance Patient convenience Attractive market,28,New Trends in Drug Development目前的新走向,Now the classic drug discovery model is supplemented by传统的新药开发模式由下面两种方式进行补充 Project in-licensing 项目引进 Life Cycle Management (LCM) 产品周期的管理 Outsourcing,29,Outsourcing,为什么要 Outsourcing? Capaci
13、ty Management 人力资源的调控 Technology/Specific expertise 新技术 Strategic 战略上的考虑 Cost control 控制成本 Deadline 时间,30,新药研发的费用分布 2001,31,Source of patients for clinical trials 1997-2001,Year enrolment completed,Percentage of total patients recruited,32,Impact of therapeutic area on enrolment period,(n) = number
14、of clinical studies,33,Outsourcing of CMC,Proportion of R&D expenditure spent on CMC activities in 2001,Proportion of R&D Full Time Equivalents allocated to CMC in 2001,CMC outsourcing expenditure as a percentage of total CMC expenditure,34,Conclusions 结语,开发具有国内或国外水平的新药不仅要依靠企业本身的实力, 还要眼光向外. 有效的引进新项目及专利是目前国际上流行做法. 对已有的上市产品， 要利用新技术进行多次开发和产品周期管理(LCM)，以维持和延续产品的寿命和市场份额。 一旦中国的产品质量，技术及GMP得已保证， Outsourcing, Generic chemical drug and biotech strategy 中国的制药企业对上述所提的问题都得到加强时，那么中国制药企业的崛起将为时不远,35,Questions? ?,谢谢 !,36,
