金城醫藥(300233.SZ):胞磷膽鹼鈉注射液獲得藥品註冊證書
格隆匯6月13日丨金城醫藥(300233.SZ)公佈,公司全資子公司北京金城泰爾製藥有限公司於近日收到國家藥品監督管理局下發的胞磷膽鹼鈉注射液藥品註冊證書(證書編號:2023S00817、2023S00818)。
胞磷膽鹼鈉主要用於急性顱腦外傷及腦手術後的意識障礙。原研廠家為Ferrer Internacional S.A.,該公司胞磷膽鹼鈉注射液於1975年6月在西班牙獲批上市,商品名為“Somazina®”。米內網數據顯示,2020到2022年,胞磷膽鹼相關製劑全國銷售額分別約為25億元人民幣、28億元人民幣、27億元人民幣,其中注射劑佔通用名銷售額的20%以上。
截至公吿披露日,國內胞磷膽鹼鈉注射液通過/視同通過仿製藥質量和療效一致性評價的上市許可持有人包括湖北科倫藥業有限公司、華潤雙鶴利民藥業(濟南)有限公司、辰欣藥業股份有限公司等多家企業。
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