中國生物製藥(01177.HK)"注射用重組人凝血因子VIIAN01"獲批上市
格隆匯7月3日丨中國生物製藥(01177.HK)公吿，集團開發的"注射用重組人凝血因子VIIaN01"(商品名：安啟新)已獲得中國國家藥品監督管理局的上市批准，用於凝血因子VIII或IX的抑制物>5個Bethesda單位(BU)的成人及青少年(12歲以上)先天性血友病患者的出血的治療。安啟新是國內首個獲批上市的國產重組人凝血因子VIIa類生物製品。
全球血友病患者人數呈持續增長趨勢，統計數據顯示，全球血友病患者約83.6萬人，其中嚴重型約28.4萬人。重型血友病A患者抑制物發生率約為30％，非重型為3-13％，而血友病B患者為1-6％。抗體陽性會導致傳統替代治療效果不佳，嚴重影響患者生存質量。重組人凝血因子VIIa因其高效止血作用和獨特的旁路效應，已成為抑制物陽性患者的重要治療選擇，並在全球範圍內得到廣泛應用。
安啟新是目前國內唯一通過III期臨牀試驗確證療效和安全性的重組人凝血因子VIIa，其獲批基於一項在伴有抑制物血友病患者中的多中心、單臂、開放評估有效性和安全性的III期臨牀研究。該研究共入組60例受試者，均至少使用過一次試驗藥物，其中53例受試者累計發生559次出血事件。對551次可評估的出血事件進行分析，止血有效率為88.93%(95%CI86.01，91.43)。
在生產工藝方面，重組人凝血因子VIIa存在結構複雜、降解和氧化位點較多、雜質種類較多等挑戰，集團創新地開發了細胞培養、分離純化和製劑處方等具有自主知識產權的工藝，並獲得兩項原創專利"人凝血因子VIIa的純化方法(ZL202010330060.5)"和"重組人凝血因子VIIa的藥物組合物(ZL202410278314.1)"。集團已成功進行了多批次商業化生產放大，產品批間質量一致性良好，充分證明了生產工藝的穩健性。
安啟新作為國內首個獲批的國產注射用重組人凝血因子VIIa產品，將為患者提供更經濟優質的治療選擇。此前，集團注射用重組人凝血因子VIII(商品名：安恒吉®)已獲批上市。集團將通過安恒吉與安啟新的組合治療方案，覆蓋從常規替代治療到抑制物管理的全病程需求，有望惠及更廣泛的血友病患者羣體。
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