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国家食品药品监督管理总局(CFDA)近日批准台湾太景(Tai Gen)生物科技公司开发的新型抗生素产品Taigexyn(nemonoxacin,奈诺沙星)胶囊在大陆地区销售,该药是由台企研发获准在大陆销售的首个1.1类新药,同时也是CFDA自2015年7月发布史上最严新药临床数据自查令以来获批的首个新药。根据2012年6月达成的一项合作协议,浙江医药股份有限公司将全权负责Taigexyn在中国大陆的生产和销售,该公司已计划在2016年下半年将产品推向市场。
The State Food and Drug Administration (CFDA) recently approved Taigexyn (nemonoxacin, nelfoxacin), a new antibiotic product developed by Taiwan’s Tai Gen Biotech Corp., for sale in the mainland of China. The drug was approved by Taiwan’s R & The first Class 1.1 new drug marketed in mainland China is also the first new drug approved by the CFDA since July 2015 when the CFDA released the most rigorous clinical data review in the history. According to a cooperation agreement reached in June 2012, Zhejiang Pharmaceutical Co., Ltd. will be fully responsible for the production and sales of Taigexyn in mainland China. The company plans to bring its products to market in the second half of 2016.