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Objective: Drug licensing transactions are constrained by many legal provisions and face many uncertainties, which confuse investors to make decisions. A reasonable risk assessment system for drug licensing transactions will help licensors grasp risks more comprehensively and carry out corresponding prevention and control.
Methods: The authors identified the risk factors through expert consultation, case analysis and other methods, and further split the risks of drug licensing transactions using the risk breakdown structure (RBS) method to obtain the risk assessment indicators of drug licensing transactions.
Results: Eight secondary assessment indicators of drug licensing transaction risk, including strategic risk, patent and intellectual property risk, clause negotiation risk, R&D risk, cooperation risk with third parties, policy supervision risk, supply chain risk, and market risk, and 37 tertiary assessment indicators of drug licensing transaction risk were identified, and a diversified drug investment risk assessment system was constructed.
Conclusion: There are many complex risks in the process of drug licensing transactions. The construction of a comprehensive and reasonable drug investment risk assessment system can help investors better identify and evaluate the risks of licensing projects before making decisions.
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目的： 药物授权许可交易在受到诸多法律条款约束的同时面临较多的不确定性，给投资者决策带来了较大的难度。合理的药物授权许可交易风险评估体系有助于许可引进方更全面地掌握风险并进行针对性地防控。
方法： 通过专家咨询法、案例分析法等方法对风险要素进行识别，运用风险分解结构（RBS）方法将药物授权许可交易风险进一步拆分，得到药物授权许可交易风险评估指标。
结果： 识别出战略布局风险、专利与知识产权风险、条款洽谈风险、研发风险、与第三方合作风险、政策监管风险、供应链风险、市场风险8个药物授权许可交易风险二级评估指标和37个药物授权许可交易风险三级评估指标。
结论： 药物授权许可交易过程中面对的风险多且复杂，通过构建全面合理的药物投资风险评估体系可以在一定限度上帮助投资者在决策前更好地识别和评估许可项目的风险。
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1中国医药工业研究总院，上海 201203
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陈孝文，男，硕士研究生，研究方向：医药风险投资。E-mail: xiaowen9757@163.com。
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陈孝文，男，硕士研究生，研究方向：医药风险投资。E-mail: xiaowen9757@163.com。
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