中國生物製藥(01177.HK)：TQB2868注射液“PD-1/TGF-β雙功能融合蛋白”獲CDE批准開展III期註冊臨牀研究
格隆匯6月10日丨中國生物製藥(01177.HK)發佈公吿，集團開發的1類創新藥TQB2868注射液「PD-1/TGF-β雙功能融合蛋白」聯合鹽酸安羅替尼膠囊和化療用於轉移性胰腺導管腺癌(mPDAC)的一線治療，已在早期臨牀試驗中顯示出優異的療效和良好的安全性。集團近期已向中國國家藥品監督管理局藥品審評中心(CDE)遞交III期臨牀溝通，並獲得CDE書面回覆同意開展。
TQB2868是目前全球研發進度最快的PD-1/TGF-β雙功能融合蛋白。TQB2868是集團自主研發的一款PD-1/TGF-β雙功能融合蛋白，通過阻斷PD-1與其配體PD-L1之間的結合，解除腫瘤細胞對T細胞的抑制作用，從而激活T細胞對腫瘤的攻擊；同時，TQB2868通過中和TGF-β信號，逆轉腫瘤細胞免疫逃逸，從而達到增強抗腫瘤療效的目的。TQB2868聯合安羅替尼與化療獨特的「免疫－靶向－化療」三重協同機制，實現了免疫激活、血管重塑與腫瘤殺傷的多靶點協同，在臨牀研究中展現出顯著的抗腫瘤效應。
II期臨牀研究(TQB2868-ALTN-II-01)的初步數據已在2025年美國臨牀腫瘤學會(ASCO)年會公佈：TQB2868聯合安羅替尼與化療的客觀緩解率(ORR)達63.9%，疾病控制率(DCR)達100%，中位無進展生存期(PFS)尚未達到，6個月PFS率達86%，中位總生存期(OS)尚未達到，預期有望超過1年。該聯合方案較目前標準治療方案展現出明顯的療效改善。集團將開展III期註冊臨牀研究，在更大樣本量的mPDAC患者中，驗證該聯合方案對比標準治療方案的有效性和安全性。
目前，全球尚無PD-1/TGF-β雙功能融合蛋白獲批上市，TQB2868研發進度全球排名第一。TQB2868聯合安羅替尼和化療方案有望成為免疫檢查點抑制劑在胰腺癌的首個一線治療方案，為胰腺癌患者的總生存期、生活質量帶來根本性改善。
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