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邁博藥業-B(02181.HK):CMAB807X臨牀試驗申請獲中國國家藥品監督管理局批准
格隆匯 01-13 20:59

格隆匯1月13日丨邁博藥業-B(02181.HK)宣佈,中國國家藥品監督管理局("NMPA")已批准CMAB807X用於治療腫瘤骨轉移的臨牀試驗申請。

CMAB807X(地舒單抗)是一種人類IgG2單克隆抗體,對人類RANKL(核因子κ-B配體受體致活劑)具有親和力和特異性,RANKL是一種跨膜或可溶性蛋白,對破骨細胞(負責骨吸收的細胞)的形成、功能及存活至關重要。CMAB807可防止RANKL激活其在破骨細胞及其前體表面的受體RANK。防止RANKL/RANK的相互作用可抑制破骨細胞的形成、功能及存活,從而減少骨吸收,增加皮質骨及小梁骨的骨量及強度。CMAB807目前正在進行骨質疏鬆症的III期臨牀試驗。CMAB807X是CMAB807的一種劑型,用於治療腫瘤骨轉移。CMAB807X的新藥申請獲NMPA批准上市後預計可用於治療腫瘤骨轉移及骨鉅細胞瘤,預防實體瘤骨轉移及多發性骨髓瘤患者骨相關事件。

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