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華東醫藥(000963.SZ):中美華東的HDM1005注射液藥品臨牀試驗申請獲得美國FDA批准
格隆匯 11-28 17:09

格隆匯11月28日丨華東醫藥(000963.SZ)公佈,2024年11月28日,華東醫藥股份有限公司全資子公司杭州中美華東製藥有限公司(以下簡稱“中美華東”)收到美國食品藥品監督管理局(以下簡稱“美國FDA”)通知,由中美華東申報的HDM1005注射液藥品臨牀試驗申請已獲得美國FDA批准,可在美國開展I期臨牀試驗。

HDM1005注射液是由杭州中美華東製藥有限公司研發並擁有全球知識產權的1類化學新藥,是多肽類人GLP-1(胰高血糖素樣肽-1)受體和GIP(葡萄糖依賴性促胰島素多肽)受體的雙靶點長效激動劑。臨牀前研究顯示,HDM1005可通過激活GLP-1受體和GIP受體,促進環磷酸腺苷(cAMP)產生,增加胰島素分泌,抑制食慾,延遲胃排空,改善脂肪代謝,具有降糖、減重及MASH改善的作用,同時,現有數據顯示HDM1005具有良好的成藥性和安全性。

相關文獻和研究表明,脂肪在上呼吸道的沉積、肌肉結構的改變以及胸腹壁脂肪的堆積均可能導致OSA。鑑於肥胖與OSA間的關係,臨牀診療指南建議對OSA患者的肥胖進行治療。臨牀前研究和已有的臨牀I期數據顯示,HDM1005具有顯著的減重效果;具有改善OSA合併肥胖或超重患者相關症狀的潛力。

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