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中國生物製藥(01177.HK):腦神經保護劑“依達拉奉注射液”獲藥品註冊證書
格隆匯 07-29 18:51

格隆匯7月29日丨中國生物製藥(01177.HK)發佈公吿,集團開發的腦神經保護劑“依達拉奉注射液”(商品名:豐海依)(獲批規格:20mL:30mg)已獲中國國家藥品監督管理局頒發藥品註冊證書。該產品按化學藥品3類申報,並視同通過仿製藥質量和療效一致性評價。

根據披露,依達拉奉是一種自由基清除劑,可減輕腦水腫和組織損傷,有效保護腦神經;不僅可用於急性腦梗死和具有出血傾向的腦栓塞的治療,也可用於罕見病漸凍人症的治療。依達拉奉是迄今唯一被臨牀驗證有效的腦神經保護劑,因其作用機制明確、臨牀療效顯着、不良反應少,已成為國內卒中急性期治療的一線用藥,被《中國急性缺血性腦卒中診治指南(2018)》、《中國腦出血診治指南(2019)》、《中國罕見病診治指南(2019)》等權威指南推薦。依達拉奉目前已在神經內科、神經外科、心內科、急診科等科室被廣泛應用,市場規模巨大。

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