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微芯生物(688321.SH):西格列他鈉聯合二甲雙胍治療2型糖尿病IND申請獲受理
格隆匯 08-24 19:26

格隆匯8月24日丨微芯生物(688321.SH)宣佈,公司全資子公司微芯藥業今日收到國家藥監局簽發的IND(新藥臨牀試驗申請)《受理通知書》,產品名稱為西格列他鈉片。

國家1類新藥西格列他鈉是公司自主設計、合成、篩選和開發的新一代胰島素增敏劑類新分子實體,單藥治療2型糖尿病的III期臨牀試驗結果表明,西格列他鈉可以持續控制血糖及伴隨脂代謝紊亂的嚴重胰島素抵抗和糖尿病。西格列他鈉是全球首個完成III期臨牀試驗的PPAR全激動劑,已於2019年9月向國家藥審中心提交了NDA(新藥申請),目前正在技術審評中。

二甲雙胍片是當前各國糖尿病治療指南推薦的用於治療2型糖尿病的一線藥物,但二甲雙胍單藥治療的年失敗率達17%,治療失敗的患者需要在二甲雙胍的基礎上加用其他作用機制互補的藥物進行二聯甚至三聯治療。西格列他鈉前期研究中顯示其作為PPAR全激動劑對於2型糖尿病患者胰島素抵抗、血糖、血脂異常等臨牀治療的綜合改善和良好的安全性,同時顯示出對於胰島、肝臟等組織器官的保護潛力,證明西格列他鈉在2型糖尿病及其相關併發症上具有進一步臨牀開發價值,預期將為這類患者帶來差異化的治療新選擇。

此次申請為西格列他鈉與二甲雙胍聯合用於治療2型糖尿病的IND申請。

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