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華東醫藥(000963.SZ):中美華東的注射用HDM2020臨牀試驗獲批

格隆匯6月26日丨華東醫藥(000963.SZ)公佈,2025年06月25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)覈準簽發的《藥物臨牀試驗批準通知書》(通知書編號:2025LP01647),由中美華東申報的注射用HDM2020臨牀試驗申請獲得批準。

注射用HDM2020是由中美華東研發並擁有全球知識產權的1類生物新藥,是一款靶向成纖維細胞生長因子受體2b(Fibroblast Growth Factor Receptor 2b,FGFR2b)的新型抗體藥物偶聯物(Antibody-drug conjugate,ADC),可特異性結合表達人FGFR2b的腫瘤細胞並通過向胞內釋放毒素載荷,發揮腫瘤殺傷作用。臨牀前研究已證明HDM2020在靶點陽性的胃癌、鱗狀非小細胞肺癌等藥效模型中顯示出強大的抗腫瘤活性,具有良好的成藥性和安全性。

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