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白雲山(600332.SH):天心製藥獲藥品註冊批件
格隆匯 03-24 18:35

格隆匯3月24日丨白雲山(600332.SH)公佈,公司控股子公司廣州白雲山天心製藥股份有限公司於2020年3月23日收到國家藥品監督管理局核准簽發的《藥品註冊批件》。

注射用克林黴素磷酸酯由法瑪西亞&普強公司(Pharmacia&UpjohnCompany)研發,該藥品原研藥注射劑型未在國內上市。國內首個仿製注射用克林黴素磷酸酯批准上市的時間是2002年。2013年4月11日,天心藥業向廣東省藥品監督管理局遞交藥品註冊申請並獲得受理,受理號:CYHS1300525粵、CYHS1300527粵、CYHS1300528粵。該品種生產現場核查通過後天心藥業於2013年10月15日向國家藥品監督管理局藥品評審中心遞交藥品註冊申請。

注射用克林黴素磷酸酯主治功能是用於治療敏感厭氧菌引起的嚴重細菌感染,也用於敏感菌,包括鏈球菌、肺炎鏈球菌、葡萄球菌引起的嚴重細菌感染,是金黃色葡萄球菌骨髓炎的首選治療藥物。

目前,國內生產廠商主要有福安藥業集團有限公司、安徽省先鋒製藥有限公司、江蘇九旭藥業有限公司、海南葫蘆娃製藥有限公司等。根據Pharmarket數據庫數據,2019年注射用克林黴素磷酸酯在全國重要城市醫院(677家)和147城市用藥銷售額是3102.08萬元。截至目前,天心藥業該藥品已投入研發費用約人民幣472萬元。

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