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華領醫藥-B(2552.HK):《自然-醫學》發佈兩篇關於全球首創糖尿病新藥多格列艾汀III期研究結果同行評議論文,表現亮眼
格隆匯 05-13 09:06

5月13日|華領醫藥-B(2552.HK)今日宣佈,國際頂級醫學刊物《自然-醫學》(Nature Medicine)雜誌同時在線發表了兩篇公司全球首創糖尿病新藥葡萄糖激酶激活劑(GKA)多格列艾汀(dorzagliatin)的III期註冊臨牀研究結果的同行評議論文。

其中,SEED研究(播種研究)為多格列艾汀單藥研究,是在新診斷未用藥的2型糖尿病患者中進行的隨機、雙盲、安慰劑對照的III期註冊臨牀研究。DAWN研究(黎明研究)為在二甲雙胍足量治療失效的2型糖尿病患者中使用多格列艾汀聯合二甲雙胍治療的隨機、雙盲、安慰劑對照III期註冊臨牀研究。兩項研究數據均顯示療效顯著並長期持續,耐受性和安全性良好。

多格列艾汀III期臨牀研究是GKA類藥物在全球範圍首次完成的確證性臨牀研究,也是首個以中國臨牀團隊為主導,以中國受試者為研究對象完成的全球首創糖尿病新藥臨牀研究。而其臨牀研究成果首次發表在《自然-醫學》雜誌,證明國際頂尖學術界對中國新藥開發能力的認可與肯定,也代表中國大型註冊臨牀研究成果開始走上國際舞台。

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