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石藥集團(01093.HK)於澳大利亞提交在研同類首創新藥ALMB-0168臨牀試驗申請
格隆匯 11-27 17:49

格隆匯11月27日丨石藥集團(01093.HK)發佈公告,公司附屬公司AlaMab Therapeutics Inc(. “AlaMab”)已向澳大利亞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)首次進入人體臨牀試驗 (First-in-human)申請。

根據披露,ALMB-0168為一款同類首創(First-in-class)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牀急需的重大疾病。ALMB-0168於2019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,以及在臨牀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牀試驗申請。AlaMab並計劃在中國及美國等國家啟動該在研新藥的相關臨牀研究。

據悉,AlaMab為一家位於美國致力於同類首創抗體藥物開發的創新生物醫藥公司,其另一個針對同一靶點的在研新藥ALMB-0166就用於治療急性脊髓損傷目前於澳大利亞處於一期臨牀試驗階段。

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