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2017年FDA共批准46种新分子实体药物 (new molecular entities, NMEs), 批准新药上市申请 (new drug applications, NDAs) 34种、新生物制剂上市申请 (biologics license applications, BLAs) 12种.新药批准数量是2016年 (22个) 的2倍多, 创下20年来最高纪录.共受理新药上市申请48种, 略高于往年;15种 (32.61％) 新药获批首创一类新药;孤儿药热度依然较高, 17种 (36.96％) 孤儿药获得批准;有17种新药通过创新突破性疗法通道获得批准.新药研发重点领域集中在抗肿瘤药、抗感染药、神经系统药物、代谢及内分泌系统药物.46款新药中约有1/3的新药有潜力成为重磅“炸弹”药物.“,”FDA approved a total of 46 novel new drugs, known as new molecular entities (NMEs) in2017, including 34 new drug applications (NDAs) and 12 new biological applications (BLAs). Approvals were up by over double from the 22 approved in 2016. The number of NMEs applications in 2017 with 48 applications was slightly higher than the previous years. 2017 was the year to date for first-in-class and orphan-drug approvals, with15 (32. 61％) first-in-class and 17 (36. 96％) orphan designees in the approval cohort. 17 NMEs had breakthrough-therapy designation. The current focus for drug R&D is on antineoplastic drugs, antimicrobial drugs, neurology drugs, metabolism and endocrinology drugs. About 1/3 of the 46 new drugs could become blockbuster drugs.