通讯作者: 韩优莉, hanyouli@ccmu.edu.cn

DOI：10.12201/bmr.202106.00021

Research on the development strategies of new antineoplastic agents: An analysis based on the comparison of new drugs launched in China, America and Japan

• 摘要：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：我国药品研发能力提升显著，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。

  关键词： 抗肿瘤药；药品上市审批；药品创新; ; 

   

  Abstract: Objective: Based on the listing of new drugs in China, the United States and Japan, this article summarized the current development status and problems of new antineoplastic agents in China and put forward policy recommendations on improving domestic antineoplastic agents innovation and development policies. Methods: This article combed the definition of “new drugs” in China, the United States and Japan. Based on the new drug listing data in various countries in 2019, the types of new drugs listed, the original research manufacturers, the indications and timeliness of listed antineoplastic agents were compared and analyzed. Results: China’s pharmaceutical research and development capabilities have improved significantly, but its international influence still needs to be improved. In 2019, China’s number of new drugs approved for marketing surpassed those of the United States and Japan, but we still lagged behind the others in the timeliness of marketed antineoplastic agents; We still need to continuously improve policies and regulations to promote the development of new antineoplastic agents. Conclusion: We need to provide policy support and guidance from the whole process of the development and production of new antineoplastic agents, encourage companies to increase investment in research and development. At the same time, we still need to focus on improving the drug examination and approval system, and ultimately achieve patient access and continuous innovation.

  Key words: Antineoplastic agents; Drug examination and approval; Drug innovation

  提交时间：2021-10-08

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• 序号	提交日期	编号	操作
  1	2021-06-08	bmr.202106.00021V1	下载

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