海思科(002653.SZ)：獲得達比加羣酯膠囊臨牀試驗受理通知書
格隆匯1月16日丨海思科(002653.SZ)公佈，公司之全資子公司四川海思科製藥有限公司於近日收到國家藥品監督管理局下發的《受理通知書》，藥品名稱為達比加羣酯膠囊。
達比加羣酯膠囊為公司與西班牙埃斯特維製藥公司(Esteve Pharmaceutical S.A.)合作產品。達比加羣酯(甲磺酸鹽)是繼華法林之後60年來首個上市的全新口服直接抗凝血藥物。達比加羣酯是達比加羣的前體藥物，屬非肽類凝血酶抑制劑，口服經胃腸吸收後體內轉化為具有直接抗凝血活性的達比加羣。達比加羣結合於凝血酶的纖維蛋白特異結合位點，阻止纖維蛋白原裂解為纖維蛋白，從而阻斷了凝血瀑布網絡的最後步驟及血栓形成。同時，達比加羣可以從纖維蛋白一凝血酶結合體上解離，發揮可逆的抗凝作用。
達比加羣酯最早由德國勃林格殷格翰(Boehringer Ingelheim)公司研發，並於2008年首次在英國上市，商品名為“PRADAXA®”(膠囊劑)。隨後在全球多個國家上市，並於2010年10月獲得FDA批准。2013年在中國獲批進口上市，主要用於成年非瓣膜性心房顫動患者的卒中和全身性栓塞預防。
經查詢，目前該產品由勃林格殷格翰(中國)投資有限公司進口(分包裝)銷售。2016年之後，正大天晴藥業集團股份有限公司、成都倍特藥業有限公司、江蘇豪森藥業集團有限公司、成都苑東生物制藥股份有限公司分別按4類申報上市申請，目前均在審評審批中；四川海思科製藥有限公司按5.2類報進口臨牀申請，目前在審評審批中。
據IMS數據，達比加羣酯2018年全球銷售額約21.57億美元。
據米內網數據，達比加羣酯2018年全國銷售額約4.5億元，佔整體抗血栓市場的2.85%。
公司與西班牙埃斯特維製藥公司合作開發達比加羣酯膠囊，埃斯特維負責該產品的研發及生產供貨，公司負責該產品在中國大陸境內的研發、申報和商業化銷售。
西班牙埃斯特維製藥公司最早成立於1929年，總部設立在西班牙巴塞羅那。埃斯特維業務涉及創新藥、仿製藥及原料藥等製藥研發生產全領域。
達比加羣酯膠囊臨牀試驗的受理標誌着公司該品種在中國大陸境內研發工作取得了新的進展，如順利獲批將進一步豐富公司產品線，增強公司市場競爭力。
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