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金城醫藥(300233.SZ):金城金素注射用頭孢地嗪鈉(0.5g、1.0g)通過仿製藥質量和療效一致性評價

格隆匯7月1日丨金城醫藥(300233.SZ)公佈,公司控股子公司廣東金城金素製藥有限公司(簡稱“金城金素”)於近日收到國家藥品監督管理局下發的注射用頭孢地嗪鈉(0.5g、1.0g)藥品補充申請批準通知書(通知書編號:2025B02869、2025B02866),該藥品通過仿製藥質量和療效一致性評價。

頭孢地嗪鈉是第三代頭孢菌素,臨牀上主要用於鏈球菌屬、肺炎球菌等敏感菌所致的肺炎、支氣管炎、咽喉炎、扁桃體炎、腎盂腎炎、尿路感染、淋菌性尿道炎、膽囊炎、膽管炎、婦科感染、敗血癥及中耳炎等。

中國爲頭孢地嗪鈉主流銷售國家。米內網顯示2022年至2024年國內公立醫療全規格注射用頭孢地嗪鈉銷售額分別爲:10.74億元人民幣、6.75億元人民幣、3.94億元人民幣。截至本公告披露日,國內注射用頭孢地嗪鈉已批準上市的廠家包括山東羅欣藥業集團股份有限公司、麗珠集團麗珠製藥廠、華北製藥河北華民藥業有限責任公司、蘇州東瑞製藥有限公司等企業。

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