華東醫藥(000963.SZ):中美華東申報的注射用HDM2012臨牀試驗申請獲得批准
格隆匯7月18日丨華東醫藥(000963.SZ)公佈,2025年07月17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)核准簽發的《藥物臨牀試驗批准通知書》(通知書編號:2025LP01825),由中美華東申報的注射用HDM2012臨牀試驗申請獲得批准。
注射用HDM2012是由杭州中美華東製藥有限公司自主研發的一款靶向人粘蛋白-17(Mucin17,MUC-17)的新型抗體藥物偶聯物(Antibody-drug conjugate,ADC),由抗MUC-17的單克隆抗體與拓撲異構酶I抑制劑通過可裂解連接子偶聯而成,藥物抗體偶聯比(DAR)為8。本品屬於全球首創的1類生物製品,中美華東擁有全球知識產權。HDM2012通過抗體的靶向作用特異性識別MUC-17陽性表達的腫瘤表面抗原,利用靶抗原介導的內化作用使ADC進入腫瘤細胞內部,連接子斷裂釋放出毒素小藥,發揮抗腫瘤作用。同時HDM2012的旁觀者效應也發揮一定程度的腫瘤殺傷效果。臨牀前研究結果顯示,HDM2012具有良好的成藥性、安全性和有效性。HDM2012在多個腫瘤模型中表現出優異的抗腫瘤效果;在動物試驗中耐受性良好。
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