2018年8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 August 2018

2018年8月,美国、欧盟和日本共批准41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 August 2018, US Food and Drug Administration（FDA）, European Commission, and Ministry of Health, Labour and Welfare（MHLW） of Japan had totally approved 41 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.