2017年全球新药研发报告——第一部分：新药和生物制剂（Ⅱ）

Report of New Drugs Research and Development in 2017 Part I： New Drugs ＆ Biologics （Ⅱ）

2017年全球首次获批或上市的新药和生物制剂共113种，包括酋次上市的52种新药和生物制剂，其中有7种为首创药物（first-inclass），即该药物具有全新作用机制并在全球首次获批并上市：36种产品线拓展产品（即新适应证、新联合用药和新制剂等）：以及2017年首次获批、但2017年12月31日前尚未上市的25种产品。美国是全球新药研发最活跃的市场，肿瘤是最为活跃的治疗领域。在制药和生物技术领域年度报告的第—部分中，将深入报道这些新药和生物制剂的相关信息。

This review presents the 113 new drugs and biologics that were approved or launched for the first time globally in 2017. Fifty- two new drugs and biologics reached their first markets worldwide in 2017. 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, 36 notable line extensions （i.e., new indications, new combinations and new formulations of previously marketed products） were introduced in 2017. The remaining 25 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 3 1, 2017. The United States was the most active naarket for new drugs, and oncology was the most active therapeutic group.Information on these new arrivals is covered in depth in part I of our annual review of the pharma and biotech industry.