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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,这一数字相对较低。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。在制药和生物技术领域年度报告的第一部分中,将深入报道这些新药的相关信息。
Nearly 90 new drugs and biological products were first approved or marketed in the world in 2016, including important new drug extensions. Compared with previous years, this figure is relatively low. In 2016, a total of 44 new drugs and new biological products were listed for the first time in the world, a decrease of nearly 10% over the previous year. Of the new marketed drugs, seven are first drugs, a new drug with a new mechanism of action and the first in the world to be approved and marketed. In addition, a total of 23 new extension drugs (ie new formulations, new combinations and new indications) were approved in 2016. Another 21 products were first approved in 2016 but not yet available as of December 15, 2016. In the first part of the annual report on pharmaceuticals and biotechnology, the relevant information on these new drugs will be reported in depth.