中國生物製藥(01177.HK):"注射用福沙匹坦"獲得歐盟上市許可
格隆匯1月8日丨中國生物製藥(01177.HK)公告,公司附屬公司正大天晴藥業集團股份有限公司研製的預防化療引起的噁心嘔吐藥物"注射用福沙匹坦"獲歐盟頒發藥品上市許可證書。
注射用福沙匹坦是集團獲得歐盟上市許可的首個注射劑產品。與口服劑型相比,注射劑產品在研發過程、生產製造、質量管控等方面都有更高的技術要求。此次獲批,標誌着集團在注射劑研發、生產與質量管控等方面均獲得了歐盟官方的認可和肯定。本集團已經與歐盟銷售夥伴達成合作協定,計劃在2020年上半年實現該產品在歐盟的上市銷售。
2019年10月,集團研製的注射用福沙匹坦(商品名稱:善啟)在中國獲批上市。該產品此次獲得歐盟上市許可,説明其質量不僅滿足中國標準,同時也符合歐盟標準。集團將一如既往的以最嚴格的標準要求,向中國患者提供優質的藥品。
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