四環醫藥(00460.HK):硫酸氫氯吡格雷片(75毫克)獲批生產上市
格隆匯11月9日丨四環醫藥(00460.HK)宣佈,集團開發的硫酸氫氯吡格雷片(75毫克)(“該產品”)獲得中華人民共和國國家藥品監督管理局頒發的生產批件,允許該產品生產,視同通過仿製藥質量和療效一致性評價。
該產品是一種血小板聚集抑制劑,屬抗血栓形成藥,用於以下患者的動脈粥樣硬化血栓形成事件:(1)近期心肌梗死患者(從幾天到小於35天),近期缺血性卒中患者(從7天到小於6個月)或確診外周動脈性疾病的患者;及(2)急性冠脈綜合徵的患者。該產品抗血小板作用強,安全性高,為中國國內外指南推薦藥物,是治療腦卒中、心肌梗死及其他外周動脈疾病的一線用藥。該產品屬於中國國家醫保乙類、國家集採品種。
據IQVIA數據顯示,2017至2019年,血小板聚集抑制劑藥物國內銷售額分別為人民幣113億元、人民幣125億元和人民幣140億元,複合增長率達7.4%,持續增長。其間,硫酸氫氯吡格雷在血小板聚集領域市佔比一直維持在60%以上,國內銷售額均超過人民幣80億元,位居血小板聚集領域市場第一。
心腦血管領域為集團重點佈局領域,該次硫酸氫氯吡格雷片(75毫克)獲批准生產上市,將進一步惠及廣大患者,同時為集團的心腦血管藥物管線再添一重磅品種,利於該藥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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