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石藥集團(01093.HK):降血糖藥"鹽酸二甲雙胍緩釋片"獲藥監局藥品註冊批件
格隆匯 09-26 12:10

格隆匯9月26日丨石藥集團(01093.HK)公佈,集團附屬公司石藥集團歐意藥業有限公司開發的"鹽酸二甲雙胍緩釋片(0.75g、0.5g)"獲國家藥監局頒發藥品註冊批件,兩個規格產品均視同於通過仿製藥品質和療效一致性評價,且0.75g規格為國內獨家產品。該產品為中美雙報品種,於2016年5月已獲美國FDA批准上市。

公告顯示,二甲雙胍為降血糖藥,主要用於改善2型糖尿病患者的糖耐量狀況,不僅降低基礎血糖,也降低餐後血糖。該產品既可以單獨使用也可以與磺脲類藥物或胰島素聯合使用,以達到控制2型糖尿病患者血糖的作用。鹽酸二甲雙胍緩釋片為高端緩釋製劑,服用方式為1次╱日,日服用次數較普通速釋製劑有明顯優勢,用藥方式更加便捷。

此外,鹽酸二甲雙胍緩釋片為集團降血糖藥物的重點產品之一。受遺傳或環境因素的影響,糖尿病人數逐年增加,預期該產品具有廣闊的市場和臨牀應用前景。該產品的上市將進一步豐富集團的產品組合,有助集團在抗糖尿病領域的發展。

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