微芯生物(688321.SH):西格列他鈉治療非酒精性脂肪肝II期臨牀試驗獲受理
格隆匯 3 月 23日丨微芯生物(688321.SH)公佈,公司全資子公司成都微芯藥業有限公司(“成都微芯”)近日收到國家藥品監督管理局(“國家藥監局”)簽發的《受理通知書》,該產品名稱為西格列他鈉片。
臨牀試驗階段:西格列他鈉治療非酒精性脂肪肝(NASH)II期臨牀試驗。
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,對PPARγ、PPARα和PPARδ3個亞型均具有適度的激活活性,具有改善胰島素抵抗、改善血脂異常和降低冠狀動脈疾病風險、減輕脂肪肝和降低甘油三酯,改善能量代謝的作用。前期的臨牀試驗研究顯示,PPARγ可以促進肝臟脂肪轉移至皮下,同時PPARδ/α可以促進肝臟的脂肪氧化和脂質轉化,從而降低循環脂質水平,對脂代謝紊亂和脂肪肝有保護作用。因此,其不但顯示出對2型糖尿病患者的胰島素抵抗、血糖、血脂異常等具有良好的治療效果,同時還顯示出對於胰島、肝臟、腎臟等組織器官的保護潛力,這是公司申請西格列他鈉治療非酒精性脂肪肝的重要基礎。
西格列他鈉是全球首個完成III期臨牀試驗的PPAR全激動劑,單藥用於治療飲食、運動控制不佳的2型糖尿病的NDA(新藥申請)已於2019年9月被國家藥監局受理,目前正在進行現場生產核查。
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