華東醫藥(000963.SZ):中美華東的注射用HDM2005獲得美國FDA新藥臨牀試驗批准
格隆匯7月1日丨華東醫藥(000963.SZ)公佈,近日,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(以下簡稱“中美華東”)收到美國食品藥品監督管理局(以下簡稱“美國FDA”)通知,由中美華東申報的注射用HDM2005藥品臨牀試驗申請已獲得美國FDA批准,可在美國開展I期臨牀試驗。
注射用HDM2005是由杭州中美華東製藥有限公司研發並擁有全球知識產權的1類生物新藥,是一款靶向受體酪氨酸激酶樣孤兒受體1(ROR1)的抗體偶聯藥物(ADC)。臨牀前研究顯示,HDM2005進入體內後,抗體部分與表達腫瘤抗原的靶細胞特異性結合,HDM2005被腫瘤細胞內吞後,細胞毒素在胞內釋放,從而完成對腫瘤細胞的殺傷;現有數據顯示HDM2005具有良好的成藥性和安全性。
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