全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展的最新趨勢(已修改)
2025-01-08 14:21 本頁面
【正文】 ) 全球醫(yī)藥產(chǎn)業(yè) 研究 與發(fā)展的最新趨勢 胡江濱 美中藥協(xié) (SAPA) 北京 , 2023 1 ) 報告內(nèi)容 ? 全球制藥界新藥開發(fā)最新概況 ? 新藥開發(fā)值得注意的走向 ? Project inlicensing 項目引進(jìn) ? Life Cycle Management (LCM) 產(chǎn)品周期的管理 ? Outsourcing What Why and (How) ? 2 ) 223 236 249 285 296 297 308 337 364 396 0 100 200 300 400 500 600 1992 1993 1994 1995 1996 1997 1998 1999 2023 2023 2023p 2023p Global pharmaceutical sales (US$ billion) 420 445 Year p = projection Source: Sales data for 19922023 supplied by IMS Health 全球藥品銷售 19922023p 3 ) 0 60 80 100 120 140 160 180 200 1992 1993 1994 1995 1996 1997 1998 1999 2023 2023 2023p Year Indexed values (1992 = 100) 全球研發(fā)費用 全球新藥上市 研發(fā)時間 (3 year moving average) 全球銷售 全球銷售，研發(fā)費用及研發(fā)時間和新藥上市 19922023p 4 ) Research Late Development Early Development Regulatory assessment Commercialisation Clinical evaluation US FDA: yrs EMEA: yrs Japanese MHLW: yrs Duration (median) Attrition (Number of pounds entering stage per pound launched) 9 1 1 新藥 RD 的過程 Target discovery Lead discovery Lead optimisation 5 ) 11% 16% 44% 79% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% First human dose to Market 臨床一期 First patient dose to Market 臨床二期 First pivotal dose to Market 臨床三期 Submission to market 申報 Success rate 新藥上市的成功機率 6 ) 8% 13% 40% 77% 34% 46% 76% 88% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% First human dose to market First patient dose to market First pivotal dose to market Submission to market Success rate Chemical entities Biotech Success rate to market by product type 7 ) 戰(zhàn)略考慮2 2 . 9 %毒性2 3 . 5 %臨床安全1 2 . 0 %臨床療效2 1 . 9 %其他1 9 . 7 %P r e c l i n i c a l e f f i c a c y2 . 8 %P r e c l i n i c a l P k / b i o a v a i l a b i l i t y2 . 2 %F o r m u l a t i o n1 . 4 %P a t e n t o r C o m m e r c i a l l e g a l 1 . 0 %R e g u l a t o r y0 . 6 %O t h e r5 . 4 %C
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