2011年美國(guó)食品藥品監(jiān)督管理局（FDA）共批準(zhǔn)30個(gè)新藥。簡(jiǎn)要介紹其中的重點(diǎn)品種，并就新藥研發(fā)的現(xiàn)狀與趨勢(shì)進(jìn)行分析。在2011年FDA批準(zhǔn)上市的新藥中，有11個(gè)為首創(chuàng)一類新藥，其中50余年來(lái)首次上市的系統(tǒng)性紅斑狼瘡治療藥物貝利單抗、30余年來(lái)首次獲準(zhǔn)上市的霍奇金淋巴瘤靶向治療藥物本圖希單抗-維度汀、慢性丙型肝炎治療藥物特拉普韋和波塞普韋、腫瘤免疫治療藥物依普利單抗、基于基因?qū)W檢測(cè)的腫瘤個(gè)體化治療藥物克唑替尼和維拉芬尼等藥物作用獨(dú)特或市場(chǎng)前景廣闊，頗受關(guān)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.

國(guó)家重大新藥創(chuàng)制專項(xiàng)（2011ZX09401-009）