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2018年5月,美国、欧盟和日本共批准27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 May 2018, US Food and Drug Administration (FDA), European Commission, and Japanese Ministry of Health, Labour and Welfare (MHLW) had totally approved 27 new drugs, including new molecular entities, new active ingredients, 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.