2020年美欧日首次批准的新药评述  

Review of New Drugs Firstly Approved by FDA,EMA and PMDA in 2020

作　　者：魏利军 WEI Lijun(Harbin Pharmaceutical Group Co.,Ltd.,Harbin 150070,China)

机构地区：[1]哈药集团股份有限公司,黑龙江哈尔滨150070

出　　处：《药学进展》2021年第3期227-240,I0003,I0004,共16页Progress in Pharmaceutical Sciences

摘　　要：美国是全球第一大药品市场,2020年美国FDA批准的53个新分子实体或新生物药中,40个为全球范围内首次批准的产品。除美国之外,欧洲和日本也是全球创新药的主要市场,欧洲药品管理局和日本医药品和医疗器械局批准的产品中分别有6和13个为全球首次批准。这些新药的上市,将解决多种疾病无药可治的问题,也将为一些适应证提供全新的治疗选择。对2020年美、欧、日首次批准的新药的研发历程、临床疗效、市场预期进行简介和点评,为研发人员提供借鉴和参考。The United States is the largest drug market,40 out of the 53 new molecule entities(NME)or biologics license applications(BLA)approved by the Food and Drug Administration(FDA)were first approvals over the world.In addition,Europe and Japan are also the major markets for global innovative drugs.In the products approved by the European Medicines Agency(EMA)and the Japanese Pharmaceuticals and Medical Devices Agency(PMDA),6 and 13 were firstly approved globally,respectively.The marketing of these new drugs will solve the problem with many diseases lacking effective treatments,and provide new therapeutic options for some indications.Hereby we briefly introduce and review the R&D history,clinical effects and marketing prospective of the new drugs firstly approved by FDA,EMA and PMDA in 2020,so as to provide reference for new drug researchers.

关 键 词：创新药 孤儿药 抗肿瘤药 首次批准 临床研究 市场前景 

分 类 号：R97[医药卫生—药品]