2023年美国与我国批准新药的对比分析  

Comparative Analysis of New Drugs Approved by the United States and China in2023

作　　者：麻巧宁 郑杨 元延芳 王闻雅 Ma Qiaoning;Zheng Yang;Yuan Yanfang;Wang Wenya(National Medical Products Administration Institute of Executive Development,Beijing 100073,China;Beijing Tsinghua Changgung Hospital,Beijing 102218,China)

机构地区：[1]国家药品监督管理局高级研修学院,北京100073 [2]清华大学附属北京清华长庚医院,北京102218

出　　处：《中国药事》2024年第11期1235-1246,共12页Chinese Pharmaceutical Affairs

摘　　要：目的:对2023年美国FDA批准的新药进行分析,并与我国2023年新药审批相关情况进行对比分析,以供业界参考。方法:通过查阅美国FDA CDER发布的《2023年新药审批总结报告》、我国药品审评中心发布的《2023年度药品审评报告》、Drugs@FDA数据库、国家药品监督管理局发布的药品批件及药品审评中心公开的上市药品信息,结合相关文献,收集并统计分析2023年FDA批准的新药信息,并与我国的相关情况做对比分析。结果与结论:2023年,FDA批准了55个新药,涵盖肿瘤、遗传/罕见病、神经系统疾病等多个疾病领域。51%的新药获得了孤儿药认定,36%的新药被认定为“first-in-class”,65%的新药审批至少使用了一种加速审评程序。获批新药的企业涵盖广泛,从大型制药巨头到中小型生物技术公司均有不同数量的新药获批。我国批准新药74个,疾病领域广泛性和多样性与FDA不相上下,但新药创新性及罕见病药物的开发有待提升。38%的新药审批至少使用了一种加速上市程序。新药审评用时比2022年减少,但一次性通过率降低,反映了监管的趋严性。药企需提升申报资料质量。监管部门需完善药品监管法规,加强药品监管人员的培训和教育,提升其专业水平和国际视野。Objective:To analyze the new drugs approved by the U.S.FDA in 2023 and compare them with the new drug approvals in China during the same year,providing a reference for the pharmaceutical industry.Methods:By reviewing the"2023 New Drug Approval Summary Report"released by the US FDA CDER,the"2023 Drug Evaluation Report"released by China's CDE,Drugs@FDA database,drug approvals published by the NMPA,and publicly available information on marketed drugs from the CDE,combined with relevant literature,data on new drugs approved by the FDA in 2023 were collected and statistically analyzed,and compared with the relevant situation in China.Results and Conclusion:In 2023,the FDA approved a total of 55 new drugs,including treatments for various medical fields such as oncology,genetic/rare diseases,and neurological disorders.51%of the new drugs received orphan drug designation,36%of the new drugs were recognized as"first-in-class",and 65%of the new drug approvals utilized at least one expedited program.Furthermore,the companies that have been approved for new drugs cover a wide range,from large pharmaceutical giants to small and medium-sized biotechnology firms,with varying numbers of new drug approvals.China approved 74 new drugs,and the breadth and diversity of disease fields are comparable to those of the FDA.However,the innovation of new drugs and the development of rare disease drugs need to be improved.38%of the new drug approvals in China included at least one expedited marketing process.The time required for new drug review has decreased compared to 2022,but the one-time pass rate has also decreased,reflecting the increasing strictness of regulation.Pharmaceutical companies need to improve the quality of their application materials,and regulatory authorities need to improve drug regulation laws,strengthen the training and education of drug regulatory personnel,and enhance their professional level and international perspective.

关 键 词：FDA 新药审批 罕见疾病 加速审批 “first-in-class”新药 

分 类 号：R95[医药卫生—药学]