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苑東生物(688513.SH):獲得達比加羣酯膠囊藥品註冊證書
格隆匯 04-16 16:23

格隆匯 4 月 16日丨苑東生物(688513.SH)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的達比加羣酯膠囊《藥品註冊證書》。

達比加羣酯(甲磺酸鹽)是繼華法林之後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201010月獲得FDA批准。2013年在中國獲批進口上市,主要用於預防成人非瓣膜性房顫患者的卒中和體循環栓塞治療急性深靜脈血栓形成(DVT)/或肺栓塞(PE) 以及預防相關死亡預防複發性深靜脈血栓形成(DVT)/或肺栓塞(PE)以及相關死亡。

根據國家藥監局網站數據查詢,目前國內達比加羣酯膠囊獲批廠家有Boehringer Ingelheim、江蘇豪森、正大天晴此外,另有齊魯製藥(海南)、四川科倫、南京海辰等公司提交仿製藥申請。米內網重點省市公立醫院數據庫顯示,2020年達比加羣酯在中國重點省市公立醫院終端銷售額約為3.18億元。

202017日,公司向國家藥監局提交的達比加羣酯膠囊註冊申請獲得受理。截止公吿日,該產品累計已投入研發費用約3622.67萬元。

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