基于中美日新药上市现状对比的抗肿瘤新药发展策略研究

目的:以中国、美国及日本的新药上市情况为依据,总结我国当前抗肿瘤新药的发展现状及问题,对今后我国抗肿瘤药的创新研发及审评审批政策的完善提出建议。方法:梳理中国、美国、日本对"新药"概念的界定,基于2019年各国新药上市数据,对上市新药的类别、原研企业进行比较,并对上市抗肿瘤药的适应证、原研企业、时效性等进行对比分析。结果:我国药品研发能力显著提升,但国际影响力仍有待增强;2019年我国新药上市数量超越了美国和日本,但在上市抗肿瘤药的时效性上仍有较大差距;我国对药品创新研发的扶持力度有待加强。结论:我国需要从抗肿瘤新药研发的全流程视角进行政策支持和引导,激励企业增加研发投入力度,完善药品审评审批制度,实现抗肿瘤新药的患者可及和持续创新发展。

A study on the strategies for development of new antineoplastic agents: Based on the comparison of new drug listings in China, the United States and Japan

Objectives:Based on the situation of new drug listings in China, the United States and Japan, this Paper aims to summarize the current development status and problems of new antineoplastic agents in China as well as to put forward suggestions on improving Chinese policies for innovative development, review and approval of antineoplastic agents. Methods:This paper sorted up the definition of "new drugs" in China, the US and Japan. Based on the 2019 new drug listing data of various countries, types of new drugs listed and original research manufacturers were compared; meanwhile, the indications, original research manufacturers and timeliness of listed antineoplastic agents were compared and analyzed. Results:China''s capacity in pharmaceutical research and development have improved significantly, but its international influence still needs to be enhanced. In 2019, China''s annual number of new drugs approved for marketing surpassed those of the US and Japan, but China still lags behind these two countries in terms of timeliness of listed antineoplastic agents; and China still needs to improve support for promoting the innovative development of new antineoplastic agents. Conclusions:China needs to provide policy support and guidance for the whole process of the development of new antineoplastic agents, encourage companies to increase their investment in research and development. Meanwhile, China still needs to further improve the drug review and approval system, and ultimately achieve patient access to and continuous innovative development of new antineoplastic agents.