華東醫藥(000963.SZ):中美華東合作開發的HDP-101(HDM2027)臨牀試驗申請獲得批准
格隆匯10月15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:2024LP02317),由中美華東與公司德國參股公司Heidelberg Pharma AG(以下簡稱“Heidelberg Pharma”)合作開發的HDP-101(HDM2027)臨牀試驗申請獲得批准。
HDP-101(HDM2027)是一種新型ADC(Antibody-Drug Conjugates,抗體偶聯藥物)藥物,由人源化抗BCMA抗體與蘑菇毒素α-鵝膏蕈鹼肽衍生物偶聯而成。HDP-101通過特異性與漿細胞(Plasmacell,PC)的BCMA蛋白結合並內化的方式,殺死漿細胞,從而實現細胞毒性有效載荷的轉運。
目前HDP-101處於臨牀開發階段,尚未在任何國家獲批上市。本品已獲得美國FDA及波蘭、匈牙利和德國監管機構批准,開展一項評估HDP-101在包括多發性骨髓瘤在內的漿細胞疾病患者中的安全性、耐受性、藥代動力學特徵和有效性的1/2a期臨牀研究。該項臨牀研究的首例受試者給藥已於2022年2月15日完成。此外,2024年3月27日,FDA授予HDP-101治療多發性骨髓瘤的孤兒藥認定(ODD)。
2024年8月,中美華東和Heidelberg Pharma遞交的HDP-101中國臨牀試驗申請獲得受理,並於近日獲得NMPA批准,同意本品在中國開展臨牀研究。
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