紅日藥業(300026.SZ):伊班膦酸鈉注射液獲藥品註冊批件
格隆匯5月13日丨紅日藥業(300026.SZ)公佈,公司於近日收到國家藥品監督管理局下發的藥品註冊批件(批件號:2020S00240),藥品名稱為伊班膦酸鈉注射液;劑型為注射劑;規格:1ml:1mg(以伊班膦酸計)。
伊班膦酸鈉注射液系第三代雙膦酸鹽類藥物,由瑞士羅氏製藥公司研發,於1996年在德國首次上市,商品名為Bondronat。主要治療絕經後骨質疏鬆症、預防乳腺癌骨轉移患者骨相關事件的發生(包括病理性骨折、需放療或手術的骨併發症)、治療伴有或不伴有骨轉移的惡性腫瘤引起的高鈣血癥。與其他雙膦酸鹽類藥物相比,伊班膦酸鈉具有高效、低毒,使用方便,適應症廣等優點,尤其是其腎毒性在膦酸鹽類藥物裏最小,對腎臟安全性最高,在臨牀應用上具有更強的優勢。
據米內網數據,伊班膦酸鈉注射液2017年、2018年、2019年的中國銷售額分別為5.2億、6.7億和8.4億,近三年每年保持了近27%增長幅度。
公司產品伊班磷酸鈉注射液獲得國家藥品監督管理局的《藥品註冊批件》,標誌着公司具備了在國內市場銷售該藥品的資格,進一步豐富了公司的產品線,有利於提升公司在骨科疾病用藥市場的競爭力,對公司的經營業績產生積極的影響。
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