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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。
In September 2015, the United States, the European Union and Japan approved a total of 46 new drugs, including new molecular entities, new active ingredients, new biological products, new indications and new dosage forms. This article analyzes the first new molecular entities, new active ingredients, and new biological products in the world that are approved for the first time, highlighting the clinical research findings and the historical development of these drugs.