全球医药产业研究和发展的最新趋势.ppt

中国仿制药企业的现状 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 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) ? 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 Many 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 2,055 Pravachol BMS Sankyo 1990 2,266 Fosamax Merck Gentili 1993 2,250 Lipitor Pfizer Warner Lamb 1997 7,972 Celexa Forest Labs Lundbeck 1998 1,451 Revenues from in-licensing are increasing…引进项目的产品销售正在不断提高 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 Increasing value of development and marketed products through arrangements with third parties 联和开发和销售 　 项目引进包括哪些方面 项目引进案例 1999-2002 Competition for Deals Is Also Increasing Standard Processes and Team Work 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 Large Number of Opportunities Evaluated for Every Deal Closed 110 Contacts 65 Early Assessments 17 Initial Evaluations 9 Due Diligences 3 Neogtiations 1 Deal Closed New Trends in Drug Development目前的新走向 Life Cycle Management include Prolonged/Modified release dosage forms Fixed combination with other drugs Enhanced bioavailability New drug delivery principles Targeted or site-specific drug delivery Global Drug Delivery Market, 2001 各大公司用于LCM方面的研发费用 Wellbutrin: Growth of a Blockbuster Why Develop Fixed