维立志博-B(09887):LBL-024于一线治疗胆道癌II期试验的首例患者用药

智通财经
Oct 27, 2025

智通财经APP讯,维立志博-B(09887)发布公告,评价奥帕替苏米单抗(PD-L1/4-1BB双特异性抗体LBL-024)用于一线治疗胆道癌的II期临床试验首例患者已成功用药,标志着该核心产品适应症拓展高效推进。

本次开展的开放标签、多中心II期临床研究由复旦大学附属中山医院周俭教授牵头,正在全国多家医院同步推进。该试验旨在评价奥帕替苏米单抗联合用药一线治疗晚期胆道癌患者的疗效及安全性。

LBL-024是一种同时靶向PD-L1与4-1BB的双特异性抗体,为针对肺外神经内分泌癌的全球首款达到注册临床阶段的靶向4-1BB受体的疗法。LBL-024亦有望成为治疗晚期肺外神经内分泌癌的首款获批药物。凭藉我们专有的X-bodyTM平台, LBL-024采用最佳的2:2结构设计,可解除PD-1/L1免疫抑制并强化4-1BB调节的T 细胞激活,实现协同消灭肿瘤的效果,具有较PD-1/L1抑制剂更强的广谱癌症治疗潜力。

本公司于2024年4月获得国家药品监督管理局(NMPA)批准开展单臂注册临床试验,于2024年10月自NMPA获得LBL-024治疗后线晚期肺外神经内分泌癌的突破性疗法认定(BTD),并于2024年11月自美国食品药品监督管理局(FDA)获得 LBL-024治疗神经内分泌癌的孤儿药认定(ODD)。

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