2019年10—11月美国、欧盟和日本新批准药物概述  

An Overview of New Drugs Approved in the US, EU and Japan in October and November 2019

作　　者：孙友松 SUN Yousong(Shanghai Pharmadigger Technology Co.,Ltd.,Shanghai 201210,China)

机构地区：[1]上海递鸽医药科技有限公司

出　　处：《药学进展》2019年第12期955-960,共6页Progress in Pharmaceutical Sciences

摘　　要：2019年10-11月,美国、欧盟和日本共批准46个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。In October and November 2019, US Food and Drug Administration(FDA), European Commission, and Ministry of Health, Labour and Welfare(MHLW) of Japan had totally approved 46 new drugs, including new molecular entities, new active ingredient, new biologics and new line extensions(new indications and new formulations). In this article, new molecular entities, new active ingredients and new biologics receiving their first global approval were analyzed with emphasis on the outcomes of clinical trials and development histories.

关 键 词：新药批准 临床试验 新分子实体 新生物制品 

分 类 号：R97[医药卫生—药品]