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石藥集團(01093.HK):普盧格列汀片獲國家藥品監督管理局批准上市
格隆匯 01-13 17:34

格隆匯1月13日丨石藥集團(01093.HK)宣佈,集團開發的化學藥品1類新藥普盧格列汀片(商品名:善澤平)(「該產品」)已獲中華人民共和國國家藥品監督管理局批准上市。

該產品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,該產品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。該產品適用於改善成人2型糖尿病患者的血糖控制(包括單藥治療和當單獨使用鹽酸二甲雙胍仍不能有效控制血糖時的聯合治療)。

支持該產品獲批的兩項關鍵Ⅲ期臨牀試驗(普盧格列汀片單藥Ⅲ期試驗和普盧格列汀片聯合鹽酸二甲雙胍Ⅲ期試驗)的試驗結果均顯示該產品具有持久的降糖作用且不易誘發低血糖和增加體重。此外,該產品不良反應發生率和與其他藥物發生相互作用的可能性較低,輕中度腎功能不全患者服用該產品時無需調整劑量。

2型糖尿病是成年人中最常見的糖尿病類型。根據國際糖尿病聯盟的估計,2021年全球估計約有5.4億成年人(年齡在20–79歲之間)患有糖尿病,其中中國約有1.4億人,並預計到2045年中國患有糖尿病的成年人人數將增加至1.74億。

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