2016年全球新药研发报告——第一部分：新药和生物制品（Ⅱ）

Report of New Drugs Research and Development in 2016 Part I：New Drugs ＆ Biologics （Ⅱ）

2016年全球首次批准或上市的新药和生物制品接近90种，其中包括重要的延伸性新药。与往年相比，这—数字相对较低。2016年全球首次上市的新药和新生物制品共44种．比前一年减少近10％。新上市药物中，7种药物为首创药物，即具有全新作用机制，并在全球首次通过批准并上市的新药。此外，2016年共批准了23种延伸性新药（即新配方、新联合用药和新适应证）。另有21种产品于2016年首次获批，但截至2016年12月15日尚未上市。在铜告的第一部分中，将深入报道这些新药的相关信息。

Nearly 90 new drugs and biologics, including important new line extensions, were approved or launched for the first time globally in 2016, a comparatively lower number with respect to previous years. Forty-four new drugs and biologics reached their first markets worldwide in 2016, nearly 10% fewer than the previous year. Seven of the new launches were first-in-class agents, meaning the first drug with a novel mechanism of action to be approved and launched anywhere in the world. In addition, 23 novel line extensions （i.e., new formulations, new combinations and new indications） were introduced last year. The remaining 21 products discussed in this article were approved for the first time during the year just passed, but had not yet been launched as of December 15, 2016. Information on these new arrivals is covered in depth in part I of our annual review of the pharma and biotech industry.