2023年中国和美国批准上市创新药的比较  

Comparison of innovative drug approvals in China and the United States in 2023

作　　者：干长姣 元延芳 郑杨 杨悦 房军 GAN Chang-jiao;YUAN Yan-fang;ZHENG Yang;YANG Yue;FANG Jun(National Medical Products Administration Institute of Executive Development,Beijing 100071,China;School of Pharmaceutical Science,Tsinghua University/Key Laboratory of Innovative Drug Research and Evaluation,National Medical Products Administration,Beijing 100084,China)

机构地区：[1]国家药品监督管理局高级研修学院,北京100071 [2]清华大学药学院/国家药品监督管理局创新药物研究与评价重点实验室,北京100084

出　　处：《中国新药杂志》2025年第8期790-796,共7页Chinese Journal of New Drugs

摘　　要：目的:比较2023年中国和美国批准上市创新药和新药的异同点,以期为我国创新药研发提出建议。方法:比较2023年中国和美国批准上市创新药和新药的批准类型、持有人/生产商、靶点、适应证、是否采用加快上市注册程序等情况。结果:2023年我国共批准了40个创新药,适应证以抗肿瘤和免疫机能调节、抗感染用药为主,与美国相比,孤儿药研发不足。结论:我国新药研发实力和审评审批效率进一步提高,但创新研发体系仍需完善。Objective:To compare the similarities and differences of the innovative drug and novel drug approvals in China and the United States in 2023,in order to make suggestions for the research and development(R&D),review and approval policies of innovative drugs in China.Methods:The approval types,applicants/manufacturers,targets,indications,and whether to use one or more expedited programs were compared.Results:Forty innovative drugs were approved in China in 2023 and mainly are antineoplastic and immunomodulating agents and anti-infectives for systemic use.The orphan drug R&D is insufficient compared with the United States.Conclusion:The R&D strength of innovative drug and review and approval efficiency have been further improved in China,but the innovative research and development system still needs to be improved.

关 键 词：创新药 审评审批 创新药研发 

分 类 号：R95[医药卫生—药学]