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百奧泰(688177.SH):BAT1308注射液聯合BAT4706注射液及注射用BAT8008治療晚期實體瘤獲得藥物臨牀試驗批準通知書

格隆匯8月7日丨百奧泰(688177.SH)公佈,近日收到國家藥品監督管理局覈準簽發的《藥物臨牀試驗批準通知書》,公司在研藥品BAT1308注射液聯合BAT4706注射液及注射用BAT8008治療晚期實體瘤的臨牀試驗申請獲得批準。

BAT1308注射液是百奧泰自主研發的人源化抗PD-1單克隆抗體,其活性成分是一種由中國倉鼠卵巢細胞表達的靶向人程序性細胞死亡蛋白1(PD-1)的抗體,屬於免疫球蛋白IgG4κ亞型,能夠以高親和力特異性地結合人PD-1,從而阻斷PD-1與其配體PD-L1、PD-L2的相互作用。BAT1308能夠與T細胞表面的PD-1結合,解除PD-1通路對T細胞的抑制作用,從而恢復和提高T細胞的免疫殺傷功能,抑制腫瘤生長。BAT4706注射液是百奧泰開發的一項經無巖藻糖基化優化的IgG1類全人源單克隆抗體候選藥物,靶點爲細胞毒性T淋巴細胞相關抗原4(CTLA-4),用於治療晚期實體瘤。CTLA-4是在調節性T細胞(Tregs)及活化的CD4+及CD8+T細胞上表達的免疫檢查點。BAT4706能特異性結合CTLA-4分子,恢復T細胞的活化,同時其增強的抗體依賴的細胞毒性作用(ADCC)能導致腫瘤微環境的Tregs凋亡,從而提高機體對癌症的免疫反應。研究已證實CTLA-4單抗單藥或聯合用藥對多種實體瘤治療有良好抗腫瘤作用。

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