金城醫藥(300233.SZ):乳糖酸紅黴素獲得化學原料藥上市申請批準通知書
格隆匯8月5日丨金城醫藥(300233.SZ)公佈,公司之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乳糖酸紅黴素的《化學原料藥上市申請批準通知書》(通知書編號:2025YS00668)。
注射用乳糖酸紅黴素是一種大環內酯類抗生素,用於治療較爲嚴重的感染性疾病,最早由Abbott Laboratories(雅培公司)申請,於1964年6月在美國獲批上市,被FDA列爲參比製劑。目前包括我公司在內國內有四家企業的乳糖酸紅黴素批文在原料藥登記平臺上狀態爲A。國內目前尚無注射用乳糖酸紅黴素原研產品上市,有17家企業擁有注射用乳糖酸紅黴素批文。根據IMS數據查詢,2022年至2024年乳糖酸紅黴素製劑全球銷售額分別爲4,474.70萬美元、5,718.86萬美元和7,245.00萬美元。
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