2020年全球获批上市的原创新药:回顾与展望

Global approved new drugs in 2020:retrospect and prospect

2020年新型冠状病毒肺炎疫情席卷全球,人类生命健康受到重大威胁,全球生物医药行业格局也迎来新的变化。美国FDA的药物评估与研究中心(CDER)在2020年批准了53款创新药,其中40个为全球范围内首次批准。欧洲EMA全年批准了34款创新药,其中6个为全球首次批准。日本医药品和医疗器械局(PMDA)全年批准了38款创新药,其中有13个为全球首次批准的产品。国家药品监督管理局(NMPA)共批准了48款新药,其中9个产品为本土企业研发且在全球首次获批。这些新药的上市,将为多种疾病提供全新的疗法或更多的治疗选择。本文回顾总结了2020年美国、欧盟、日本和我国获批上市的全新药物,并对2021年新药研发进行简要展望,旨在为新药研发工作者提供参考。

The COVID-19 epidemic has swept the world in 2020,posing a major threat to human life and health.The global biopharmaceutical landscape will also change.The Center for Drug Evaluation and Research(CDER)of the US FDA approved 53 innovative drugs in 2020,40 of which were first approved worldwide.The European EMA approved 34 innovative medicines throughout the year,including 6 for the first approval in the world.Japan’s Medical Products and Medical Devices Agency(PMDA)approved 38 innovative drugs throughout the year,including 13 for the first approval in the world.National Medical Products Administration(NMPA)approved 48 innovative drugs throughout the year,9 of which were developed by local companies and approved for the first time in the world.The launch of these new drugs will provide brand new therapies or more treatment options for a variety of diseases.This paper reviewed the new drugs approved for the market in the US,EU,Japan and China in 2020,and gave a brief outlook on the new drug development in 2021,aiming to provide reference for people engaged in new drug research and development.