石藥集團(01093.HK):在研新藥ALMB-0168獲准在澳大利亞進行臨牀試驗
格隆匯2月24日丨石藥集團(01093.HK)宣佈,公司附屬公司AlaMab已獲得相關倫理委員會及臨牀試驗機構批准,並收到政府監管機構(Therapeutic Goods Administration)的臨牀試驗通知確認函(Acknowledgementof Clinical Trial Notification),可以在澳大利亞啟動在研新藥ALMB-0168用於治療骨癌和癌症骨轉移的首次進入人體的臨牀試驗。
ALMB-0168為一款同類首創(first-in-class)針對全新靶點半通道膜蛋白Connexin43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。此次臨牀試驗的批准,體現了監管機構對ALMB-0168作為同類首創新藥的臨牀前試驗結果和臨牀試驗可行性的認可。
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但不同機制的在研新藥ALMB-0166用於治療急性脊髓損傷目前正在開展Ⅰ期臨牀試驗。AlaMab並計畫在中國及美國等國家啟動ALMB-0166和ALMB-0168的相關臨牀研究,以期更快推動這兩個藥物的研發進程。
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