天宇股份(300702.SZ):利伐沙班原料藥獲得CEP證書
格隆匯1月27日丨天宇股份(300702.SZ)公佈,公司收到歐洲藥品質量管理局(以下簡稱“EDQM”)簽發的關於利伐沙班原料藥的歐洲藥典適用性認證證書(以下簡稱“CEP證書”)。
利伐沙班屬於抗凝血藥物,用於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);或用於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(PE)的風險;或用於非瓣膜性房顫成年患者,以降低卒中和全身性栓塞的風險。公司於2020年10月向EDQM遞交了利伐沙班原料藥的藥品註冊申請並獲得CEP證書。公司在利伐沙班片研發項目上已投入研發費用約人民幣456萬元。
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