石藥(01093.HK)附屬於澳洲提交治療骨癌首創新藥臨床試驗申請
石藥集團(01093.HK)公布,附屬AlaMab Therapeutics Inc已向澳洲相關倫理委員會提交在研新藥半通道Connexin 43 (Cx43)人源化單克隆抗體激動劑(ALMB-0168)首次進入人體臨床試驗
(First-in-human)申請。
集團指,ALMB-0168為一款同類首創針對全新靶點半通道膜蛋白Cx43的人源化單克隆抗體激動劑,由AlaMab自主研發用於治療骨癌、癌症骨轉移及骨質疏鬆等臨床急需的重大疾病。ALMB-0168於今年相繼獲得美國FDA頒發用於治療骨癌的孤兒藥資格認定和罕見兒童疾病資格認定。基於體內外藥理和藥效學實驗結果,以及在臨床前毒理學研究中顯示的安全性,ALMB-0168成功在澳大利亞提交臨床試驗申請。AlaMab並計畫在中國及美國等國家啟動該在研新藥的相關臨床研究。
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