中國生物製藥(01177.HK):減肥創新藥GMA106(GIPR拮抗╱GLP-1R激動劑)IB/II期臨牀試驗申請獲CDE受理
格隆匯10月16日丨中國生物製藥(01177.HK)公吿,由集團聯合開發的1類創新藥GMA106(GIPR拮抗╱GLP-1R激動劑)已向中國國家藥品監督管理局藥品審評中心(CDE)提交Ib/II期臨牀試驗申請並獲得受理,用於治療成人超重和肥胖症患者。
GMA106是一款GIPR(胃抑制多肽受體)拮抗╱GLP-1R(胰高血糖素樣肽-1受體)激動劑,通過利用特有的M-Body技術,可以使其在特異性阻斷GIPR信號通路的同時激活GLP-1R,從而有望實現以下效果:1.減重效果顯著:降低體內脂肪蓄積,減緩胃排空,抑制食慾,通過多通路協同達到比單GLP-1受體激動劑更好的減肥效果;2.安全性良好:在澳洲進行的I期臨牀試驗初步數據顯示出良好的耐受性與安全性;3.防止反彈:未揭盲的初步藥效數據顯示出GMA106在停止給藥後的3-5個月仍具有防止體重反彈的潛力;4.依從性高:其分子半衰期長,有望以每2周或每4周用藥一次的頻率治療,提高長期用藥的依從性。
GMA106已於2021年11月在澳洲開展Ⅰ期臨牀。在中國,GMA106計劃通過Ib期研究進一步確認更高劑量在超重和肥胖人羣中多次給藥的安全性和耐受性。II期研究將在不同隊列中探索不同劑量和長週期給藥頻率治療24周和36周後的初步療效。
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