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金城醫藥(300233.SZ):子公司收到注射用鹽酸米諾環素的藥物臨牀試驗批準通知書
格隆匯 03-13 16:22

格隆匯3月13日丨金城醫藥(300233.SZ)公佈,山東金城醫藥集團股份有限公司之控股子公司廣東金城金素製藥有限公司於近日收到國家藥品監督管理局下發的注射用鹽酸米諾環素《藥物臨牀試驗批準通知書》(編號:2025LP00684)。

注射用鹽酸米諾環素靜脈注射適用於治療由指定細菌的敏感分離株引起的感染:由立克次體引起的落基山斑疹熱、斑疹傷寒和斑疹傷寒羣、Q熱、立克次體痘和蜱熱;由肺炎支原體引起的呼吸道感染;由沙眼衣原體引起的性病淋巴肉芽腫;由鸚鵡熱衣原體引起的鸚鵡熱(鳥疫);由解脲脲原體或沙眼衣原體引起的成人非淋菌性尿道炎、宮頸或直腸感染;由迴歸熱螺旋體引起的迴歸熱;由鼠疫耶爾森菌引起的鼠疫;由土拉弗朗西斯菌引起的兔熱病;由霍亂弧菌引起的霍亂;由胎兒彎曲菌引起的胎兒彎曲菌感染;由布魯氏菌引起的布魯氏菌病(與鏈黴素合用);由桿菌狀巴爾通體引起的巴爾通體病;由肉芽腫克雷伯菌引起的腹股溝肉芽腫。

注射用鹽酸米諾環素的主流銷售地區爲美國,根據IMS數據顯示2020至2023年美國地區該藥物的銷售額分別爲:142萬美元、173萬美元、236萬美元和323萬美元。截止本公告披露日,國內暫無獲批上市的注射用鹽酸米諾環素,且廣東金城金素製藥有限公司爲國內首家獲得該藥物臨牀試驗批準的製藥企業。

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