華東醫藥(000963.SZ):中美華東申報的HDM1005注射液臨牀試驗申請獲得批准
格隆匯2月24日丨華東醫藥(000963.SZ)公佈,2025年2月24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(簡稱“中美華東”)收到國家藥品監督管理局(NMPA)核准簽發的《藥物臨牀試驗批准通知書》(通知書編號:2025LP00440和2025LP00441),由中美華東申報的HDM1005注射液臨牀試驗申請獲得批准。
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,改善代謝功能,進而改善血漿容量、減少氧化應激和全身炎症、改善心血管適應性;具有降糖、減重、MASH的作用。同時,現有數據顯示HDM1005具有良好的成藥性和安全性。
HDM1005注射液為多肽類人GLP-1受體和GIP受體的雙靶點長效激動劑,GLP-1類產品具有減肥、降糖和心血管獲益等作用,是相對成熟和安全的靶點。本次HDM1005注射液臨牀試驗獲批,是該款產品研發進程中的又一重要進展,將進一步提升公司在內分泌治療領域的核心競爭力。
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