信達生物(01801.HK)：國藥監局受理瑪仕度肽的首個減重適應症新藥上市申請
格隆匯2月7日丨信達生物(01801.HK)宣佈，中國國家藥品監督管理局("NMPA")已經正式受理胰高血糖素樣肽-1受體("GLP-1R")╱胰高血糖素受體("GCGR")雙重激動劑瑪仕度肽(研發代號：IBI-362)的首個新藥上市申請("NDA")已獲中國國家藥品監督管理局("NMPA")藥品審評中心("CDE")受理，用於成人肥胖或超重患者的長期體重控制。
此前，瑪仕度肽在中國超重或肥胖成人受試者中的III期臨牀研究GLORY-1(NCT05607680)已於2024年1月達成主要研究終點和所有關鍵次要終點，瑪仕度肽4mg組和6mg組受試者體重和多項心血管代謝指標的改善均顯著優於安慰劑組。GLORY-1研究治療期間，瑪仕度肽整體安全性良好，安全性特徵與瑪仕度肽的既往臨牀研究一致，未發現新的安全性信號。公司計劃將於2024年學術大會和學術期刊公佈GLORY-1研究的詳細數據。
肥胖是一項成因複雜的慢性代謝性疾病，是導致糖尿病、脂肪肝、心腦血管疾病、腎病、關節疾病、呼吸睡眠障礙和癌症等一系列疾病的重要病因或危險因素。隨着經濟發展和生活方式的改變，中國肥胖症的患病人數已躍居世界首位i。超重和肥胖的早期預防和及時干預，可以有效降低體重過度增高所導致的疾病如心血管疾病、糖尿病、高血壓、脂肪肝等慢性病發生的風險，切實提升居民健康水平，減輕疾病負擔。在一些超重和肥胖者中，單純生活方式干預的減重效果往往有限且難以維持，在此基礎上選用安全、有效的減重藥物治療可以顯着改善體重，改善與體重有關的心血管代謝風險因素，從而改善健康結局。
瑪仕度肽是全球首個NDA的GLP-1R/GCGR雙重激動劑，作為具有創新作用機制的新一代減重藥物，有望為中國廣大的超重和肥胖人羣的長期體重管理帶來更強效、安全、簡捷的治療手段。公司將積極配合監管部門，期待早日為中國超重和肥胖人羣提供有效且安全的治療方案，實現科學減重和長期體重管理目標。
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