新天藥業(002873.SZ):參股公司子公司獲得“利伐沙班片”藥品註冊證書
格隆匯 1 月 12日丨新天藥業(002873.SZ)公佈,公司參股公司上海匯倫生物科技有限公司(“匯倫生物”)的全資子公司上海匯倫江蘇藥業有限公司(“匯倫江蘇藥業”)近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》(批件號:2020S00930、2020S00931、2020S00932)。
利伐沙班片的適應症為:1、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);2、用於治療成人深靜脈血栓形成(DVT)和肺栓塞(PE);在完成至少6個月初始治療後DVT和/或PE復發風險持續存在的患者中,用於降低DVT和/或PE復發的風險;3、用於具有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,以降低卒中和體循環栓塞的風險。
利伐沙班片是全球第一個口服直接Xa因子抑制劑,其選擇性地阻斷Xa因子的活性位點,且不需要輔因子(例如抗凝血酶III)以發揮活性。通過內源性及外源性途徑活化X因子為Xa因子(FXa),在凝血級聯反應中發揮重要作用。利伐沙班片在包括擇期髖關節或膝關節置換術後預防VTE、治療DVT和PE及其二級預防、房顫患者預防卒中及體循環栓塞等相關疾病治療領域獲得了國內外權威指南的推薦和認可。
匯倫生物的全資子公司匯倫江蘇藥業此次獲得“利伐沙班片”藥品註冊證書,有利於公司進一步優化產業佈局,加快進入小分子化藥領域,包括抗腫瘤、心腦血管、呼吸及消化系統等疾病的仿製藥及創新藥領域,對公司未來發展將產生積極影響,但不會對公司當期經營業績產生重大影響。
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