2013年全球新药研发报告——第一部分:新药及生物制品(Ⅰ)  

A Report of New Drugs Research and Development in 2013——Part I:New Drugs & Biologics(I)

作　　者：Graul A I Cruces E Stringer M 张宇辉(翻译)[2] 

机构地区：[1]不详 [2]中国药科大学

出　　处：《药学进展》2014年第3期224-230,共7页Progress in Pharmaceutical Sciences

摘　　要：该年度报告涉及2013年最新上市的56种新药及生物制品,包括20种新孤儿药和10种全新药物,以及获得美国FDA"新突破药物"称号的前3名药物。此外,该年度报告还讨论了30种重要的延伸性新药(新适应证、新剂型和现有药物的新复方),以及19种年内首次获批但在该报告结束时尚未上市的新药。This article provides a comprehensive overview of the 56 new drugs and biologics introduced for the first time in 2013, the largest number in at least a decade. This includes 20 new orphan drugs and 10 first-in-class agents, as well as the first three products bearing the FDA＇s new Breakthrough Therapy Designation. The review also covers 30 important new line extensions, encompassing new indications, new formulations and new combinations of previously marketed agents. In addition to this bumper crop of new launches, another 19 products were approved for the first time during the year but not yet launched by the close of this article; these new products are also discussed.

关 键 词：上市新药 新生物制品 获批新药 延伸性新药 孤儿药 

分 类 号：R97[医药卫生—药品]