华东医药(000963.SZ):多肽类人GLP-1受体和GIP受体的双靶点长效激动剂HDM1005注射液临床试验获批

智通财经
Mar 03, 2025

智通财经APP讯,华东医药(000963.SZ)发布公告,025年3月3日,公司全资子公司杭州中美华东制药有限公司(以下简称“中美华东”)收到国家药品监督管理局(NMPA)核准签发的《药物临床试验批准通知书》(通知书编号:2025LP00511和2025LP00512),由中美华东申报的HDM1005注射液临床试验申请获得批准。

据悉,HDM1005注射液是由杭州中美华东制药有限公司研发并拥有全球知识产权的1类化学新药,是多肽类人GLP-1(胰高血糖素样肽1)受体和GIP(葡萄糖依赖性促胰岛素多肽)受体的双靶点长效激动剂。临床前研究显示,HDM1005可通过激活GLP-1受体和GIP受体,促进环磷酸腺苷(cAMP)产生,增加胰岛素分泌,抑制食欲,延迟胃排空,改善代谢功能,进而改善血浆容量、减少氧化应激和全身炎症、改善心血管适应性;具有降糖、减重、代谢相关脂肪性肝炎(MASH)及射血分数保留心力衰竭(HFpEF)改善的作用。同时,现有数据显示HDM1005具有良好的成药性和安全性。

HDM1005注射液为多肽类人GLP-1受体和GIP受体的双靶点长效激动剂,GLP-1类产品具有减肥、降糖和心血管获益等作用,是相对成熟和安全的靶点。本次HDM1005注射液临床试验获批,是该款产品研发进程中的又一重要进展,将进一步提升公司在内分泌治疗领域的核心竞争力。

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