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石藥集團(01093.HK)在研新藥“ALMB-0168”1期臨牀試驗完成首例患者給藥
格隆匯 10-28 17:19

格隆匯10月28日丨石藥集團(01093.HK)發佈公告,公司附屬公司AlaMab Therapeutics Inc開發的人源化單克隆抗體ALMB-0168在澳大利亞開展的1期臨牀試驗完成首例患者給藥。

此項研究是一個在澳大利亞開展的單藥、多劑量、靜脈注射給藥的多中心、首次人體劑量遞增的1期臨牀試驗,旨在評價ALMB-0168在骨癌及癌症骨轉移患者中的安全性、耐受性、藥代動力學以及初步有效性指標。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年獲得美國FDA頒發的用於治療骨癌的孤兒藥資格認定及罕見兒童疾病資格認定,及於2020年獲得澳大利亞和中國的臨牀試驗許可。

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創新藥ALMB-0166用於治療急性脊髓損傷目前正在開展1期臨牀試驗。AlaMab將不懈努力更快推動這兩個藥物的研發。

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