翰思艾泰-B(03378)获批准于中华人民共和国开展注射用HX111临床试验

智通财经
Dec 23, 2025

智通财经APP讯,翰思艾泰-B(03378)发布公告,由本公司开发的创新药注射用HX111(HX111)已获中华人民共和国国家药品监督管理局批准于中华人民共和国境内开展临床试验。

HX111为首创(FIC)OX40靶向抗体偶联药物(ADC)。临床前研究表明,OX40为肿瘤相关抗原(TAA),于若干恶性肿瘤(包括部分淋巴瘤)中相较于正常组织呈过度表达,因而成为如HX111等ADC方式的合适靶点。此外,OX40亦在肿瘤微环境 (TME)中的调节性T细胞(Treg)呈过度表达,而该等Treg已知可抑制抗肿瘤免疫。清除该等Treg代表癌症免疫疗法的一种新作用机制(MOA),此效应可透过HX111 实现,具备潜在泛癌症应用前景。

HX111为本公司继HX009及HX044两项FIC双特异性抗体(BsAb)疗法后,推进至临床开发的第三个首创分子。本公司将继续努力,透过临床开发带来更多新颖 FIC药物,并最终推向市场。

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