摘要
2021年全球创新药物开发持续升温,药品审评审批步伐加快,各国上市新药收获颇丰。美国FDA药品评估和研究中心(CDER)在2021年共批准了50款新药,其中有38款为全球首批;欧洲EMA全年共批准了53款创新药,其中7个为全球首次批准;日本医药品和医疗器械局(PMDA)全年共批准了42款创新药,其中有7款为全球首批;国家药品监督管理局(NMPA)全年共批准了66款新药,其中在全球首次批准上市的新药有25款。本文概括总结了2021年美国、欧洲、日本和中国获批上市的新药,并展望了2022年生物医药产业的发展态势,以期为新药研发工作者提供参考。
In 2021,the development of innovative drugs around the world continued to heat up,the pace of drug review and approval was accelerated,and new drugs in various countries have reap great harvests.The Center for Drug Evaluation and Research(CDER)of FDA approved 50 new drugs in 2021,of which 38 were the first approved in the world;EMA approved 53 innovative drugs throughout the year,of which 7 were approved in the European before any other country.Japan’s Pharmaceuticals and Medical Devices Agency(PMDA)approved 42 innovative drugs throughout the year,including 7 for the first approval in the world.National Medical Products Administration(NMPA)approved a total of 66 new drugs throughout the year,including 25 new drugs approved for listing for the first time in the world.This paper summarizes the new drugs approved for listing in the United States,Europe,Japan and China in 2021,and looks forward to the development trend of biomedical industry in 2022,so as to provide reference for people engaged in new drugs R&D.
作者
杜逸航
孙友松
陈倩
杨臻峥
郑晓南
DU Yi-hang;SUN You-song;CHEN Qian;YANG Zhen-zheng;ZHENG Xiao-nan(School of Traditional Chinese Pharmacy,China Pharmaceutical University,Nanjing 211198,China;Shanghai PharmaDigger Technology Co.,Ltd.,Shanghai 201210,China;D Medicines Inc.,Shanghai 200126,China;Editorial Office of Progress in Pharmaceutical Sciences,China Pharmaceutical University,Nanjing 210009,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第11期1033-1041,共9页
Chinese Journal of New Drugs
关键词
全球首批
创新药
新型疗法
孤儿药
first approval
innovative medicines
new therapies
orphan drug
