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華東醫藥(000963.SZ):江東公司的司美格魯肽注射液上市許可申請獲受理
格隆匯 04-01 16:56

格隆匯4月1日丨華東醫藥(000963.SZ)公佈,2025年3月31日,華東醫藥股份有限公司全資子公司杭州中美華東製藥江東有限公司(簡稱“江東公司”)收到國家藥品監督管理局(NMPA)簽發的《受理通知書》(受理號:CXSS2500040;CXSS2500041;CXSS2500042;CXSS2500043),由江東公司申報的司美格魯肽注射液(研發代碼:HDG1901)上市許可申請獲得受理。

司美格魯肽注射液是一種長效胰高血糖素樣肽-1(GLP-1)受體激動劑,與人GLP-1有94%的序列同源性,臨牀上主要用於2型糖尿病患者的血糖控制、肥胖或超重患者的長期體重管理。司美格魯肽通過刺激胰島素分泌和降低胰高血糖素分泌來降低血糖。此外,司美格魯肽的降低血糖的機制還涉及輕微延遲餐後早期胃排空。同時,司美格魯肽可降低食慾和減少食物攝入量,誘導減肥,並且顯著降低2型糖尿病患者重大心血管事件(MACE)風險。

截至目前,公司在司美格魯肽注射液項目(糖尿病適應症)的研發直接投入總金額約為19,572萬元。

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