紅日藥業(300026.SZ):依諾肝素鈉注射獲批上市
格隆匯1月11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有關依諾肝素鈉注射液(0.4m;0.6ml)的藥品註冊批件(批件號:2021S01307/2021S01308)。
依諾肝素鈉注射液用於預防靜脈血栓栓塞性疾病(預防靜脈內血栓形成),特別是與骨科或普外手術有關的血栓形成;治療已形成的深靜脈栓塞,伴或不伴有肺栓塞,臨牀症狀不嚴重,不包括需要外科手術或溶栓劑治療的肺栓塞;與阿司匹林合用,治療不穩定性心絞痛及非Q波心肌梗死;用於血液透析體外循環中,防止血栓形成。
依諾肝素鈉是賽諾菲安萬特1993年獲准上市的品種,賽諾菲的依諾肝素鈉最巔峯的全球銷售額曾接近40億美元,佔據肝素類藥物市場70%份額,山德士作為美國上市的首仿藥,第一年上市即獲得10億美元的銷量。根據弗若斯特沙利文報吿,中國市場的依諾肝素鈉製劑銷售額從2014年的1.03億美元增至2019年的3.08億美元,年複合增長率為24.5%。隨着臨牀醫生及患者對抗凝重要性的認識提高,該產品在中國市場發展潛力巨大。
公司產品依諾肝素鈉注射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,有助於提升公司產品的市場競爭力,對公司的經營業績產生積極的影響。
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