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中國生物製藥(01177.HK):治療2型糖尿病藥物“恩格列淨片”獲藥品註冊證書
格隆匯 02-08 06:08

格隆匯2月8日丨中國生物製藥(01177.HK)發佈公吿,集團開發的治療2型糖尿病藥物“恩格列淨片”(商品名:塞菲可)(規格:10mg及25mg)已獲中國國家藥品監督管理局頒發藥品註冊證書,且視同通過仿製藥質量和療效一致性評價。該產品是繼卡格列淨、沙格列汀、鹽酸二甲雙胍,集團又一個獲批用於治療糖尿病的品種,內分泌領域產品線更加豐富。

根據披露,2型糖尿病是一種進展性的疾病,隨着病程的進展,對外源性的血糖控制手段的依賴逐漸增大,而現有的藥物常具有不同程度的副作用,如低血糖、體重增加等。恩格列淨是一種新型口服選擇性鈉-葡萄糖協同轉運蛋白2(SGLT2)抑制劑,通過減少腎臟的葡萄糖重吸收,其降糖作用機制不依賴於胰島素,因而造成低血糖的風險較低;還可增加熱量消耗以及尿糖排泄,從而減輕體重,並有輕度的利尿作用。作為新作用機制藥物,恩格列淨為2型糖尿病患者的治療帶來了新的希望。格列淨類藥物已被美國及歐洲糖尿病學會、美國臨牀內分泌醫師協會、國際糖尿病聯盟《老年糖尿病患者治療指南》推薦為2型糖尿病治療一線、二線用藥。

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