2010年美國食品藥品監(jiān)督管理局（FDA）共批準(zhǔn)21個新藥，簡要介紹其中的重點品種，并就新藥研發(fā)的現(xiàn)狀與趨勢進(jìn)行分析。在FDA批準(zhǔn)上市的新藥中，迪諾蘇單抗（Prolia?，denosumab）、達(dá)比加群酯（Pradaxa?，dabigatran etexilate）、芬戈萊默（Gilenya?，fingolimod）等新藥作用獨特或市場前景廣闊，頗受關(guān)注。2010年上市新藥總體數(shù)量未見增加，但其中的孤兒藥和特色藥數(shù)量明顯增多，生物制品的比重也顯著增加，體現(xiàn)出醫(yī)藥產(chǎn)業(yè)界研發(fā)重心和模式的轉(zhuǎn)變。

The US Food and Drug Administration (FDA) approved 21 new drugs in 2010. In this article, the profile of some exciting products and the trends of drug R&D was provided. Among the FDA approvals, denosumab (Prolia?), dabigatran etexilate (Pradaxa?) and fingolimod (Gilenya?) are particularly mechanistically interesting or commercially exciting. In 2010, there was not increase in the overall number, but the proportion of orphan drugs and specialty care products increased significantly, and the proportion of biologics raised obviously too, which could suggest the change of focus and mode of drug R&D.

“重大新藥創(chuàng)制”科技重大專項——系列化、國際化的國家生物醫(yī)藥國際創(chuàng)新園新藥研發(fā)綜合性大平臺建設(shè)項目（2009ZX09301-008）