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華東醫藥(000963.SZ):中美華東申報的HDM1010片藥品臨牀試驗申請獲得美國FDA批準

格隆匯6月9日丨華東醫藥(000963.SZ)公佈,2025年6月6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”)收到美國食品藥品監督管理局(簡稱“美國FDA”)通知,由中美華東申報的HDM1010片藥品臨牀試驗申請已獲得美國FDA批準,可在美國開展I期臨牀試驗,適應症爲2型糖尿病。

HDM1010片是由中美華東自主研發的HDM1002/SGLT2抑制劑固定劑量複方製劑。其中HDM1002是由中美華東自主研發並擁有全球知識產權的創新型小分子藥物,是具有口服活性、強效、高選擇性的GLP-1受體小分子完全激動劑。HDM1002可強效激活GLP-1受體,誘導環磷酸腺苷(cAMP)產生,具有強效的改善糖耐受、降糖和減重作用並且顯示出良好的安全性。

2025年4月,中美華東完成向美國FDA遞交HDM1010片的臨牀試驗申請,並於近日獲得FDA批準。

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