中國生物製藥(01177.HK)新型口服降糖藥物"維格列汀片"獲藥品註冊批件
格隆匯4月16日丨 中國生物製藥(01177.HK)宣佈,集團開發的新型口服降糖藥物"維格列汀片"已獲得中華人民共和國國家藥品監督管理局頒發藥品註冊批件。該產品按照化藥新4類申報,視同通過仿製藥質量和療效一致性評價;規格為50mg/片,與原研劑型一致,為2017版國家醫保目錄品種。
維格列汀是一種新型的口服降糖藥,在體內通過抑制二肽基肽酶-4(DPP-4),阻斷DPP-4對胰高血糖素樣肽-1(GLP-1)的降解,從而促進胰島素分泌,抑制胰高血糖素分泌,發揮降低空腹血糖及餐後血糖的作用,在控制血糖的同時逆轉糖尿病患者胰島功能不斷惡化的狀況。該藥品有良好的應用前景,目前已在多個國家上市。集團開發的維格列汀片適用於治療2型糖尿病;當二甲雙胍作為單藥治療用至最大耐受劑量仍不能有效控制血糖時,可與二甲雙胍聯合使用。此一重要口服降糖藥獲批,將進一步加強和鞏固本集團在糖尿病領域的優勢地位,與已有上市品種形成產品組合,共同深耕市場潛力巨大的慢病治療領域。
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