石藥集團(01093.HK):國家藥品監督管理局受理普盧格列汀片的上市申請
格隆匯4月26日丨石藥集團(01093.HK)公吿,公司附屬公司石藥集團中奇製藥技術(石家莊)有限公司開發的1類新藥普盧格列汀片("該產品")用於治療2型糖尿病的上市申請已獲得中華人民共和國國家藥品監督管理局正式受理。
普盧格列汀片是一種新型口服二肽基肽酶-IV(DPP-4)抑制劑,對DPP-4具有高選擇性和強抑制性。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,進而降低血糖水平且不誘發低血糖和增加體重。臨牀研究顯示該產品具有持久的降糖作用且不良反應發生率較低,將為2型糖尿病患者的治療提供更多選擇。
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