2021年美国批准上市新药数据分析  

Data Analysis on New Drug Approved for Marketing in the US in 2021

作　　者：张华吉 孙晓灿 ZHANG Hua-ji;SUN Xiao-can(Chinese Pharmaceutical Journal Co.,Ltd.,Beijing 100022,China;Beijing Huacankang International Pharmaceutical Research Co.,Ltd.,Beijing 100027,China)

机构地区：[1]《中国药学杂志》社有限公司,北京100022 [2]北京华灿康国际医药研究有限公司,北京100027

出　　处：《中国合理用药探索》2022年第10期81-86,共6页Chinese Journal of Rational Drug Use

基　　金：“科创中国”科技服务团项目(KJFWT2022-03-04)。

摘　　要：2021年,美国食品药品监督管理局(FDA)共批准50个新分子实体药物(NMEs),包括36个新药上市申请和14个生物制剂上市许可申请。对FDA网站发布的数据进行分析发现,FDA在2021年批准新药数量位居近20年的年度批准新药数量第3位。获批first-in-class新药27个(54.00%);获批罕见病用药26个(52.00%);获批上市新药大多集中在抗肿瘤药(15个,30.00%)、中枢神经系统用药(5个,10.00%)、抗感染药(4个,8.00%)和心血管系统用药(4个,8.00%)等领域。为提高审评效率,37个(74.00%)新药使用了1种或多种加速审批方式。38个(76.00%)获批新药率先在美国上市。FDA正在努力探索更有效的评价方法评估药物疗法的安全性和有效性,并运用多种方法完善审批机制、加速审批进度,推动更多的创新药物的开发与上市。In 2021,the US Food and Drug Administration(FDA)approved 50 new molecular entities(NMEs).These includes applications for 36 new drug applications(NDAs)and 14 biologics license applications(BLAs).We analyzed the data published on the FDA web(http://www.fda.gov)and found that the FDA ranked third in the number of novel drugs approved in 2021 for the last 20 years.27 of the 50 novel drugs approved in 2021(54.00%)as fi rst-in-class.26 drug(52.00%)were approved to treat rare or“orphan”diseases.The approved novel drugs are concentrated in the fi elds of anti-tumor drugs(15,30.00%),central nervous system drugs(5,10.00%),anti-infectious drugs(4,8.00%)and cardiovascular system drugs(4,8.00%).In order to improve the evaluation effi ciency,37 new drugs(74.00%)used one or more accelerated approval methods.38 novel drugs(76.00%)were fi rst approved in the United States.FDA is trying to explore more eff ective evaluation methods to evaluate the safety and eff ectiveness of drug therapy.In addition,various methods are used to improve the approval mechanism,accelerate the progress of drug approval,and promote the development and marketing of more innovative drugs.

关 键 词：创新药物 新分子实体 新药批准 数据分析 美国 

分 类 号：R95[医药卫生—药学]