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石藥集團(01093.HK):普盧格列汀二甲雙胍緩釋片獲臨牀試驗批準

格隆匯4月22日丨石藥集團(01093.HK)公告,集團開發的普盧格列汀二甲雙胍緩釋片已獲中國國家藥品監督管理局批準,可在中國開展臨牀試驗。

該產品爲全球首款獲批臨牀的由普盧格列汀和鹽酸二甲雙胍組成的新複方製劑。普盧格列汀爲二肽基肽酶-4(DPP-4)抑制劑,通過抑制DPP-4,使內源性活性胰高血糖素樣肽-1(GLP-1)水平升高,從而增強β細胞和α細胞對葡萄糖的敏感性,增加葡萄糖刺激的胰島素分泌,並增強葡萄糖對胰高血糖素分泌的抑制作用,進而改善高血糖。二甲雙胍是一種雙胍類藥物,可改善2型糖尿病患者糖耐量,並降低基礎血糖和餐後血糖。

本次獲批的臨牀適應症爲配合飲食和運動治療,用於二甲雙胍單藥治療控制不佳或正在接受普盧格列汀與二甲雙胍聯合治療的成人2型糖尿病患者。與單藥治療2型糖尿病的產品相比,該產品安全性和耐受性良好,具有較高的臨牀開發價值。

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