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

3SBio Inc.;Contents;纵观生物仿制药;生物仿制药厂家需具备较高而全面的能力;发展生物仿制药的推动力量;15%;Global State;生物药的中国市场;SFDA Regulatory Requirements;Biosimilars Market in China中国市场潜力;生物仿制药与品牌创新药;Case Study实例分析 – 重组促红细胞生成素;Recombinant Human Erythropoietin (rHuEPO) Sample List from Asia; (A) samples from China (lanes 2–9) and Korea (lanes 10–13) and (B) samples from India (lanes 1–5).;SDS–PAGE with Western blot analysis for detection of aggregation 聚合;Relative denaturation by 9G8A antibody assay to detect unfolding structure;Concentration determination by enzyme-linked immunosorbent assay (ELISA);Conclusion结论 ;Challenges for Bio