中国生物制药(01177.HK):"注射用福沙匹坦"获得欧盟上市许可
格隆汇1月8日丨中国生物制药(01177.HK)公告,公司附属公司正大天晴药业集团股份有限公司研制的预防化疗引起的恶心呕吐药物"注射用福沙匹坦"获欧盟颁发药品上市许可证书。
注射用福沙匹坦是集团获得欧盟上市许可的首个注射剂产品。与口服剂型相比,注射剂产品在研发过程、生产制造、质量管控等方面都有更高的技术要求。此次获批,标志着集团在注射剂研发、生产与质量管控等方面均获得了欧盟官方的认可和肯定。本集团已经与欧盟销售伙伴达成合作协定,计划在2020年上半年实现该产品在欧盟的上市销售。
2019年10月,集团研制的注射用福沙匹坦(商品名称:善启)在中国获批上市。该产品此次获得欧盟上市许可,说明其质量不仅满足中国标准,同时也符合欧盟标准。集团将一如既往的以最严格的标准要求,向中国患者提供优质的药品。
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