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綠葉製藥(02186.HK):創新抗體藥物BA1201在中國獲批進行臨牀試驗
格隆匯 12-14 22:03

格隆匯12月14日丨綠葉製藥(02186.HK)公吿,公司附屬公司山東博安生物技術股份有限公司發現和研發的創新抗體藥物BA1201已獲中國國家藥品監督管理局藥品審評中心批准進行臨牀試驗。

BA1201是一種抗PD-L1/TGF-β雙特異性抗體融合蛋白,用於治療晚期實體瘤等適應症。該產品同時也是博安生物首個獲批進入臨牀的雙特異性抗體在研新藥。此次獲批的臨牀試驗為一項在晚期實體瘤患者中評價BA1201的安全性、耐受性、藥代動力學特徵和初步療效的Ⅰ期臨牀研究。

區別於單抗的單一靶點,雙特異性抗體能夠同時與兩種抗原相結合,對兩種和治療癌症相關的信號通路進行調節,在腫瘤免疫治療中具有獨特優勢。BA1201是一個在PD-L1抗體C端融合TGF-βRII的雙功能抗體融合蛋白,能夠同時抑制PD-L1/PD-1信號通路和TGF-β/TGF-βRII信號通路,從而解除體內的免疫抑制,並恢復機體免疫殺傷能力,比傳統PD-L1單抗具有更強的抗腫瘤潛力。

在腫瘤微環境中,程序性細胞死亡配體-1(PD-L1)和轉化生長因子-β(TGF-β)通常高表達。PD-L1通過與淋巴細胞表面的PD-1結合,抑制淋巴細胞的增殖和活化,誘導其凋亡,導致腫瘤細胞發生免疫逃逸;而TGF-β不僅驅動腫瘤發生進程,也是免疫抑制的重要因素,可介導腫瘤細胞對抗PD-L1單抗的原發性耐藥。同時阻斷PD-L1和TGF-β兩個免疫抑制信號能產生協同抗腫瘤作用,潛在提高目前PD-L1/PD-1抑制劑普遍應答率低的問題。

臨牀前研究結果顯示:BA1201具有優異的親和力,在多個小鼠模型中展示良好的抗腫瘤活性;相比對標產品,其在PD-L1陽性細胞上的結合靈敏度更好(IC50值低三倍);在小鼠和食蟹猴體內展示良好穩定性和較長半衰期,且心臟毒性風險低。

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