四環醫藥(00460.HK)旗下利伐沙班片獲批上市 為國產第三家獲批上市
格隆匯6月11日丨四環醫藥(00460.HK)宣佈,集團附屬公司吉林四環製藥有限公司("吉林四環")研發的利伐沙班片新增規格(2.5mg)藥品補充申請獲得中國國家藥監局批准。規格2.5mg的利伐沙班片與阿司匹林聯合用藥相當於一個新產品,適應症不同於已上市的規格為10mg和15mg的利伐沙班片(用於成人靜脈血栓(VTE)、深靜脈血栓(DVT)、肺栓塞(PE)、非瓣膜性房顫)。利伐沙班片(規格2.5mg)適應症為:利伐沙班片聯合阿司匹林(ASA)用於存在缺血事件高風險的冠狀動脈疾病(CAD)或外周動脈疾病(PAD)成人患者,以降低主要心血管事件(心血管死亡、心肌梗死和卒中)風險。視同通過仿製藥品質和療效一致性評價。規格為2.5mg的利伐沙班片,四環醫藥為國產第三家獲批上市。
利伐沙班為國家醫保乙類品種,是目前被臨牀廣泛應用的一種新型口服抗凝血藥物。具有起效迅速,顱內出血發生率低,無需常規凝血監測和常規調整劑量等優勢。利伐沙班聯合阿司匹林可以顯著改善CAD/PAD患者預後,被歐、美、中等國內外權威指南推薦。
2023年上半年,在中國抗血栓藥銷售額TOP10藥物中,利伐沙班作為唯一的口服抗凝血藥入榜。根據公開數據,我國現約有1,100萬CAD患者及4,530萬PAD患者。心腦血管領域為集團重點佈局領域,四環醫藥的利伐沙班片(規格:10mg、15mg)已經於2021年3月在中國獲批上市,於2021年6月,順位被納入國家集採,本次利伐沙班片(規格:2.5mg)獲批上市,將進一步惠及廣大患者,同時為集團的心腦血管領域藥物管線再添一重要品種,利於該產品未來的市場銷售和市場競爭,對集團的經營業績產生積極影響。
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