2017年美国、欧洲和日本批准的新药总结与点评(Ⅰ)

Summary and Review of New Drugs Approved by FDA, EMA and PMDA in 2017(Ⅰ)

2017年美国食品药品监督管理局(FDA)批准了46个新分子实体(NME)和(或)新生物制品(BLA),其中35个为全球首次获批;欧洲药品管理局(EMA)批准了51个新药,其中4个为全球首次获批;日本药品和医疗器械管理局(PMDA)批准了23个新药,其中3个为全球首次获批。总结并评述这些新药的研发历程、临床研究结果和市场预期,以供参考。

In 2017, Food and Drug Administration （FDA） approved forty-six new molecular entities/new biologic license applications, thirty-five of which were granted the first-ever regulatory approval worldwide. European medicines agency （EMA） issued market authorizations to a total of fifty-one new medicinal products, four of which were new approvals globally. Pharmaceuticals and Medical Devices Agency （PMDA） approved twenty-three new medicinal products and three of them are not yet approved in any other countries. The R＆D progression, outcomes of clinical research and market expectation regarding these newly approved medicinal products were summarized so as to provide a concise reference to all interested parties.