2015年9月美国欧盟和日本新批准药物概述-药学进展.PDF

PROGRESS IN PHARMACEUTICAL SCIENCES 2015,39 9 :703-711 ( ) 703 ·世界上市新药· W O R L D N E W D R U G A P P R O VA L S 编者按： 《药学进展》自2015年第9期开始，每期推出当月美国、欧盟和日本新批准药物及研发进展系列报道，向读者及时、 全面地介绍全球新药研发动态，为从事药物研发的人员提供参考，启迪思路。 2015 年 9 月美国、欧盟和日本新批准药物概述 孙友松 [ 摘要 ] 2015 年 9 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。 本文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。 [ 关键词 ] 新药批准；临床试验；新分子实体；新生物制品 [ 中图分类号 ] R97 [ 文献标志码 ] A [ 文章编号 ] 1001-5094（2015）09-0703-09 An Overview of New Drugs Approved in the US, EU and Japan in September 2015 SUN Yousong [Abstract] In September 2015, 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 ingredients, new biologics and new line extensions (new indications and new formulations). In this article, the results of clinical trials and development histories of those new molecular entities, new F O O F N active ingredients and new biologics that reached their first market worldwide were summarized and the key events in global new drug development Cl H O F