2011年美国食品药品监督管理局（FDA）共批准30个新药。简要介绍其中的重点品种，并就新药研发的现状与趋势进行分析。在2011年FDA批准上市的新药中，有11个为首创一类新药，其中50余年来首次上市的系统性红斑狼疮治疗药物贝利单抗、30余年来首次获准上市的霍奇金淋巴瘤靶向治疗药物本图希单抗-维度汀、慢性丙型肝炎治疗药物特拉普韦和波塞普韦、肿瘤免疫治疗药物依普利单抗、基于基因学检测的肿瘤个体化治疗药物克唑替尼和维拉芬尼等药物作用独特或市场前景广阔，颇受关注。

The US Food and Drug Administration (FDA) approved 30 new drugs in 2011. In this article, the profile of some exciting products and the trends of drug R&D were provided. There are 11 first-in-class agents in the 2011 FDA approvals. Some of the drugs are particularly mechanistically interesting or commercially exciting, such as belimumab, the first new drug for systemic lupus erythematosus in more than 50 years; targeted antibody-drug conjugate brentuximab vedotin, the first new drug for Hodgkin's lymphoma in more than 30 years; telaprevir and boceprevir for the treatment of chronic hepatitis C (CHC) genotype 1 infection; cancer immune therapy product ipilimumab; crizotinib and vemurafenib, the personalized medicines based on genetics test.

国家重大新药创制专项（2011ZX09401-009）