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1982年,美国上市了第一个生物技术药物——重组人胰岛素。1989年,我国自行研制的第一个生物技术药物IFN-α1b获得成功,并于1993年上市。至此,国内的生物技术药物产业拉开了序幕。生物技术药物发展至今,已经形成了相当大的规模。2010—2011年全球生物药销售额就超过了1000亿美元,其中北美占60%,欧洲占20%,日本10%,其他国家占10%~([1])。据市场调研公司Evaluate Pharma预计,到2016年,全球十大畅销药物中有5个将是生物技术药物,其中排第一位的骨质疏松药Prolia就是生物技术药物~([2])。
In 1982, the United States launched its first biotech drug, recombinant human insulin. In 1989, China’s first self-developed biotech drug IFN-α1b was successful and was launched in 1993. At this point, the domestic biotechnology pharmaceutical industry kicked off. The development of biotechnology drugs has so far reached a considerable size. Global biopharmaceutical sales exceeded US $ 100 billion in 2010-2011, with 60% in North America, 20% in Europe, 10% in Japan and 10% ~ ([1]) in other countries. According to market research firm Evaluate Pharma, five of the top 10 best-selling drugs in the world will be biotech drugs by 2016, with Prolia, the No. 1 osteoporosis drug, being a biotech drug ~ ([2]).