复宏汉霖(2696.HK)HLX43获多国批准开展NSCLC国际多中心II期临床

格隆汇
Jul 09, 2025

近日,复宏汉霖(2696.HK)创新型程序性死亡-配体1(PD-L1)抗体偶联药物(ADC)注射用HLX43全球开发再度取得重要进展,该产品已获得中国国家药品监督管理局(NMPA)、美国食品药品监督管理局(FDA)、澳大利亚药品管理局(TGA)及日本药品医疗器械综合机构(PMDA)许可,开展针对晚期非小细胞肺癌(NSCLC)的国际多中心II期临床研究,并于此前在中国境内完成首例受试者给药。全球尚无同类靶向PD-L1的ADC产品获批上市,HLX43为全球首个进入临床II期的PD-L1 ADC。 在2025美国临床肿瘤学会(ASCO)年会上,HLX43的I期临床数据首次发布,展现出令人鼓舞的初步疗效和安全性。目前公司正在全力推进HLX43临床开发进程,积极探索其在多种实体瘤中的治疗潜力。单药之外,HLX43联用复宏汉霖自研斯鲁利单抗(H药汉斯状®,抗PD-1单抗)治疗实体瘤的 Ib/II 期临床试验也正在进行中,进一步探索“ADC+IO”的协同抗肿瘤疗效。未来,复宏汉霖将加速推动HLX43在全球范围内的研发进程,不断夯实更多创新分子的差异化布局,为更多肿瘤患者带来高质量、可负担的创新治疗方案。

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