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白雲山(00874.HK):控股子公司天心藥業注射用氨曲南獲藥品註冊批件
格隆匯 04-20 17:48

格隆匯4月20日丨白雲山(00874.HK)公佈,公司控股子公司天心藥業於2020年4月17日收到國家藥品監督管理局核准簽發的《藥品註冊批件》(批件號:2020S00188、2020S00187)。

據悉,注射用氨曲南由美國百時美施貴寶公司研發,該藥品原研藥未在國內上市,國內首個仿製注射用氨曲南批准上市的時間是2001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:CYHS1300530粵、CYHS1300529粵。該品種生產現場核查通過後,天心藥業於2013年12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。

射用氨曲南的適應症是治療敏感需氧革蘭陰性菌所致的各類感染,屬於2019年版國家醫保目錄乙類產品。經查詢,目前藥品注射用氨曲南的主要生產廠家為上海新亞藥業有限公司、山西仟源製藥有限公司、石藥集團中諾藥業(石家莊)有限公司、安徽威爾曼製藥有限公司、山東羅欣藥業集團股份有限公司。根據Pharmarket數據庫顯示,2018年該藥品在國內147個主要城市醫院的銷售額為人民幣992.8萬元。截至目前,天心藥業在藥品注射用氨曲南研發項目上已投入研發費用約為人民幣348.62萬元。

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