卫博士BiosimilarsYFW——生物仿制药的机遇及挑战2009.10.pptVIP

* * * * * * 3SBio Nondeal Roadshow V1 * 3SBio Nondeal Roadshow V1 * 3SBio Nondeal Roadshow V1 * 3SBio Nondeal Roadshow V1 * 3SBio Nondeal Roadshow V1 * 3SBio Nondeal Roadshow V1 * 3SBio Nondeal Roadshow V1 * 3SBio Nondeal Roadshow V1 * 3SBio Nondeal Roadshow V1 * * * 3SBio Nondeal Roadshow V1 * * 3SBio Nondeal Roadshow V1 * * 3SBio Inc. Biosimilars - Opportunities and Challenges 生物仿制药的机遇及挑战 Yingfei Wei, Ph.D. October 17, 2009, Beijing, China * Contents Biosimilars Overview 生物仿制药的概况 Biosimilars vs Innovators, Case Study 案例 Opportunities and Challenges 机遇及挑战 纵观生物仿制药 专利过期的生物药的复制品或仿制品(蛋白、抗体) 不同于小分子非专利药– 不可能完全等同于品牌生物药 大分子、多元化蛋白修饰 多种亚型与构象 免疫原性复杂的生产工艺 注射 高生产成本 需要特殊的质量、药效监管条例与标准 安全性 体内外分子特性及活性分析 免疫原性检测 上市后监察 需要特定法规 Years of exclusivity –创新品牌产品保护 Interchangeability/automatic substitution 处方药不可替换 Higher success rate, lower development cost 生物仿制药厂家需具备较高而全面的能力 非专利化药 专利 报批 生产 生物仿制药 市场 临床试验 Pharmacovigilance 药物警戒 生产 发展生物仿制药的推动力量 Biological drugs market is about $86 B 2007 and will exceed $135B by 2011快速增长的市场 Large number of biological drug patents expire soon ($60B by 2015) 大量专利生物药专利即将到期 Increasing market demand市场需求不断增长 Aging population老龄人口增加 Health awareness对健康的关注增加 Affordability and insurance coverage用于健康、医疗的费用不断增加 Increasing healthcare cost 健康医疗成本增加 Increasing innovative drug RD cost研发成本不断增加 廉价、安全、有效的生物药 提高成功率，降低研发生产成本，支持创新 15% 85% * * * * * * * 3% 35% 62% * * CAGR 103% Antibodies CAGR 27% Recombinant Proteins CAGR 10% * * * * * * * * * Large Molecule Drugs CAGR 18% Small molecule drugs CAGR 9% * Worldwide Market size (€B) $255B $680B 1. 2007 to 2010 based on forecasts Note: Biologicals from players in emerging markets, non-protein antiinfectives, vaccines, pregnancy hormones and non-protein hormones are excluded from the current analyses Source: Datamonitor; BCG 生物药市场增长速度超过化药 Worldwide Market size (€B) Market Size By Drug Type Biologics Mark