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全球医药产业研究与发展的必威体育精装版趋势美中药协 (SAPA)北京, 2004报告内容全球制药界新药开发必威体育精装版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) ?600600500500445420396400400364337308296297285300300249236Global pharmaceutical sales (US$ billion)2232002001001000019921993199419951996199719981999200020012002p2003pp = projectionYear全球药品销售 1992-2003pSource: Sales data for 1992-2001 supplied by IMS Health200180160140Indexed values (1992 = 100)1201008060019921993199419951996199719981999200020012002pYear全球销售,研发费用及研发时间和新药上市1992-2002p全球销售全球研发费用研发时间 (3 year moving average)全球新药上市新药 RD 的过程Early Development Late DevelopmentRegulatory assessmentCommercial-isationResearchClinical evaluationLead discoveryLead optimisationTarget discoveryPre-clinical evaluationAssay developmentUS FDA: 1.0 yrsEMEA: 1.3 yrs Japanese MHLW: 1.4 yrsDuration(median)2.9yrs1.5yrs5.7yrsAttrition(Number of compounds entering stage per compound launched)119100%90%79%80%70%60%Success rate50%44%40%30%16%20%11%10%0%First human dose toFirst patient dose toFirst pivotal dose toSubmission to market申报Market临床一期Market临床二期Market临床三期新药上市的成功机率100%Chemical entitiesBiotech88%90%77%76%80%70%60%Success rate46%50%40%40%34%30%20%13%8%10%0%First human dose toFirst patient dose toFirst pivotal dose toSubmission to marketmarketmarketmarketSuccess rate to market by product type新药开发失败的原因 1999-2001Termination reasons were provided for 498 of the 538 NASs for which development was terminated between 1999 and 2001.目前新药开发遇到的困境RD成本和风险不断提高Pipelines becoming thinner 新药项目越来越少Increasing costs for promotion 新药上市的费用越来越高Shorter product life cycles 新药产品周期不断缩短Rising generic exposure 非专利药抢占市场越来越早面对上述的挑战,国际制药界采取了些什么对策?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OutsourcingMany blockbuster drugs are externally sourced许多重磅炸弹都是从其它公司引进的。 Drug Licensee Licensor Launched 2002 sales (mio USD)Paxil GSK Novo Nordisk 1991
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