中國生物製藥(01177.HK)新型口服抗凝血藥物“達比加羣酯膠囊”獲藥品註冊批件
格隆匯3月20日丨中國生物製藥(01177.HK)發佈公告,公司附屬公司正大天晴藥業集團股份有限公司開發的新型口服抗凝血藥物“達比加羣酯膠囊”,已獲國家藥品監督管理局頒發藥品註冊批件,為該品種國內首家獲批,且視同通過仿製藥質量和療效一致性評價。該產品有兩個規格獲批(75mg、110mg),劑型與原研藥一致。此一重要產品獲批上市,將進一步鞏固集團在抗凝劑領域的優勢地位。
根據披露,達比加羣酯屬於β-丙氨酸類凝血酶抑制劑,是達比加羣的前體藥物;用於預防非瓣膜性房顫患者的卒中和全身性栓塞,治療急性深靜脈血拴形成和╱或肺栓塞以及預防其復發。達比加羣酯克服了傳統抗凝藥物華法林的諸多缺點。憑藉其抗凝療效可靠、用藥安全、服用方便等優點,達比加羣醋已於全球八十多個國家獲批,累積了大量患者的使用經驗,成為具有最豐富臨牀應用數據的重磅新型口服抗凝藥物。
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