石藥集團(01093.HK):JMT106(雙特異性融合蛋白藥物)獲中國臨牀試驗批準
格隆匯5月19日丨石藥集團(01093.HK)公告,集團開發的雙特異性融合蛋白藥物JMT106("該產品")已獲中華人民共和國國家藥品監督管理局批準,可以在中國開展臨牀試驗。該產品亦已於2024年1月獲得美國食品藥品監督管理局(FDA)批準在美國開展臨牀試驗。
該產品是一種以GPC3和幹擾素受體爲靶點的雙特異性融合蛋白藥物,通過GPC3抗體的靶向性殺傷腫瘤細胞,同時激活由幹擾素受體介導的腫瘤微環境免疫調控作用。GPC3在肝細胞癌、肺鱗癌和卵巢癌等實體瘤中特異性高表達。本次獲批的臨牀試驗適應症爲晚期實體瘤。臨牀前研究顯示,該產品的適應症廣泛,在多種惡性腫瘤模型中具有顯著的抗腫瘤作用及良好的安全性,具有較高的臨牀開發價值。
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