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石藥集團(01093.HK)在研新藥“ALMB-0166”在中國獲臨牀試驗批件
格隆匯 12-01 18:04

格隆匯 12 月 1日丨石藥集團(01093.HK)發佈公告,公司附屬公司上海恩樂邁生物科技有限公司已獲得中國家藥品監督管理局批准,可以在中國開展在研創新藥ALMB-0166用於治療急性脊髓損傷的臨牀試驗。

根據披露,ALMB-0166為一款同類首創(first-in-class)針對全新靶點半通道膜蛋白Connexin 43的人源化單克隆抗體抑制劑,由本公司附屬公司AlaMab Therapeutics Inc.(“AlaMab”)自主研發用於治療急性脊髓損傷、中風、骨關節炎及其它神經系統的重大疾病。ALMB-0166於2018年獲得美國FDA頒發用於治療急性脊髓損傷的孤兒藥資格認定,另針對該適應症在澳大利亞的I期臨牀試驗已經完成給藥,顯示了優良的安全性和耐受性。

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-0168用於治療骨癌和癌症骨轉移目前正在開展I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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