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生物制药创新面临巨大的风险,管理生物制药的创新风险必须从其创新特性入手。基于生物制药的接力创新模式,针对“发现”、“大学-专家型公司”接力“、转化”“、专家型公司-核心公司”接力“、实现”等主要环节归纳其典型创新风险,在此基础上引入“中间风险”的概念,并分析风险的关联和传导效应,进一步揭示生物制药创新风险的特性。最后针对政府主管部门的分析,提出管控生物制药安全风险的思路。
Biopharmaceutical innovations face immense risks and managing the innovation risks of biopharmaceuticals must start with its innovative features. Based on the innovation mode of biopharmaceutical relay, we aim at “discover ”, “university - expert company ” relay “, convert ” expert company core relay The main link summarizes the typical innovation risks, introduces the concept of “intermediate risk ” on this basis, and analyzes the correlation and transmission effects of risks to further reveal the characteristics of the innovation risks of biopharmaceuticals. Finally, according to the analysis of government departments, put forward ideas to control biopharmaceutical safety risks.