華東醫藥(000963.SZ):中美華東申報的HDM1002片的新藥臨牀試驗申請獲美國FDA批准
格隆匯5月15日丨華東醫藥(000963.SZ)公佈,2023年5月12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通知,中美華東申報的HDM1002片的新藥臨牀試驗(IND)申請獲得美國FDA批准(IND編號:164262),同意開展I期臨牀試驗。
HDM1002片是由杭州中美華東製藥有限公司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。臨牀前研究顯示,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。
2023年4月中美華東完成向美國FDA遞交HDM1002片的臨牀試驗申請,並於近日獲得FDA批准,同意該品開展I期臨牀試驗。該產品在中國IND申請已於2023年2月遞交。
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