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.
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)
出处
《中国新药杂志》
北大核心
2025年第8期790-796,共7页
Chinese Journal of New Drugs
关键词
创新药
审评审批
创新药研发
innovative drug
review and approval
innovative drug development
