中國生物製藥(01177.HK):LM-108“CCR8單抗”新適應症納入突破性治療藥物程序
格隆匯6月26日丨中國生物製藥(01177.HK)公告,集團與禮新醫藥科技(上海)有限公司聯合開發的LM-108「CCR8單克隆抗體(單抗)」已被中國國家藥品監督管理局藥品審評中心(CDE)納入突破性治療藥物程序(BTD),用於聯合特瑞普利單抗治療既往接受一線標準治療失敗的CCR8陽性晚期胃╱胃食管結合部(G/GEJ)腺癌。此前,LM-108已於2025年2月被CDE納入BTD,用於經免疫檢查點抑制劑治療後疾病進展的微衛星高度不穩定(MSI-H)或錯配修復缺陷(dMMR)晚期實體瘤。
LM-108是禮新醫藥利用獨家多次跨膜蛋白(GPCR)抗體發現平臺開發的Fc優化人源化單抗,LM108通過抗體依賴細胞介導的細胞毒性(ADCC)機制,特異清除腫瘤微環境中的浸潤性調節性T細胞(Tregs),同時保留外周Tregs,從而顯著增強抗腫瘤免疫應答。其獨特的作用機制可以克服PD-1/PD-L1抑制劑的耐藥性,爲免疫治療失敗患者提供新的解決方案。
LM-108作爲全球臨牀進展領先的CCR8單抗,是目前唯一同時獲得兩項突破性治療品種認定的CCR8在研藥物。目前,LM-108已啓動II期關鍵註冊臨牀研究,用於聯合特瑞普利單抗治療既往接受抗PD-1/PD-L1類藥物治療失敗的MSI-H/dMMR的晚期惡性實體瘤患者。
LM-108已在胃癌、胰腺癌、食管癌、結直腸癌等消化道腫瘤領域展現出優秀的療效,有望成爲集團的下一個「安羅替尼」。集團正在聯合禮新醫藥探索LM-108在更多瘤腫中的聯合治療方案。LM108有望爲PD-1/PD-L1治療失敗患者提供新的治療選擇,成爲腫瘤免疫治療的新一代療法。
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