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廣生堂(300436.SZ)成為利伐沙班上市許可持有人
格隆匯 04-15 12:15

格隆匯4月15日丨廣生堂(300436.SZ)宣佈,2021年4月15日,公司收到國家藥品監督管理局頒發的關於利伐沙班片的《藥品補充申請批准通知書》,同意公司作為上述藥品的上市許可持有人(原藥品註冊證持有單位為:江蘇柯菲平醫藥股份有限公司)。未來,公司將戰略佈局心血管領域產品線,進一步豐富公司產品佈局,打造新的利潤增長點。

利伐沙班是一種口服直接抑制Xa因子的抗凝藥,主要用途:1、用於擇期髖關節或膝關節置換手術成年患者,預防靜脈血栓形成;2、治療成人深靜脈血栓形成(DVT),降低急性DVT後DVT復發和肺栓塞的風險;3、預防一種或多種危險因素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;4、與阿司匹林聯合給藥,用於存在缺血事件高風險的慢性冠狀動脈疾病或外周動脈疾病患者,以降低主要心血管事件風險。

利伐沙班原研單位是德國拜耳公司,於2009年6月在中國獲准進口上市。利伐沙班片2019年中國總銷售額超過28億元,是權威指南推薦用於預防靜脈血栓栓塞的核心藥物,已列入國家醫保目錄。

公司表示,該次公司成為利伐沙班片的上市許可持有人,未來還將積極拓展心血管領域產品管線,有利於進一步優化公司產品結構,為公司帶來新的利潤增長點。公司將以藥品上市許可持有人制度為契機,積極儲備有發展潛力的藥品品種,不斷豐富公司產品線,以仿哺創,助力公司創新轉型發展。

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