華邦健康(002004.SZ):華邦製藥獲得利伐沙班片藥品註冊批件
格隆匯 2 月 2日丨華邦健康(002004.SZ)公佈,公司全資子公司重慶華邦製藥有限公司(“華邦製藥”)於近日收到國家藥品監督管理局核准簽發的化學藥品利伐沙班片的《藥品註冊批件》。
利伐沙班片主要用於擇期髖關節或膝關節置換手術成年患者,以預防靜脈血栓形成(VTE);成人深靜脈血栓形成(DVT)和肺栓塞(PE),降低急性DVT後DVT復發和肺栓塞(PE)復發的風險;亦可用於一種或多種危險因素(例如:充血性心力衰竭、高血壓、年齡≥75歲、糖尿病、卒中或短暫性腦缺血發作病史)的非瓣膜性房顫成年患者,以降低卒中和全身性栓塞的風險。
《中國腫瘤相關靜脈血栓栓塞症預防與治療專家指南(2015版)》、《中國骨科大手術靜脈血栓栓塞症預防指南》等國內權威指南,推薦Xa因子抑制劑利伐沙班等用於預防靜脈血栓栓塞。
此次華邦製藥獲得利伐沙班片的註冊批件,視同通過一致性評價,進一步豐富了公司產品管線,拓展了公司產品治療領域,對進一步豐富和優化公司產品結構、探索新的營銷模式均有積極意義。隨着該產品市場佔有率的逐步增加,對公司業績的提升將產生積極影響。
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