阿斯利康(AZN.US)三抗新药在中国再获批临床 拟用于治疗系统性红斑狼疮等
智通财经APP获悉，4月2日，中国国家药监局药品审评中心(CDE)官网公示，阿斯利康(AZN.US)申报的1类新药AZD5492在中国获批两项新的临床试验默示许可，拟用于治疗系统性红斑狼疮、特发性炎症性肌病。公开资料显示，这是一款CD20×TCR×CD8三特异性抗体，是由CD8引导的T细胞衔接器(TCE)。该产品最早于2024年10月在中国获批临床，适应症为复发性或难治性B细胞恶性肿瘤。
AZD5492是一种不对称的三特异性单克隆IgG1抗体，它含有两个抗CD20的Fab结构域、一个与TCR结合的VHH结构域，以及一个与CD8共受体结合的VHH结构域。公开资料显示，由于抗CD20抗体对B细胞的特异性作用，其被广泛开发应用于B细胞相关疾病的治疗，包括非霍奇金淋巴瘤等B细胞恶性肿瘤，以及系统性红斑狼疮、系统性硬化症、特发性炎性肌病等自身免疫性疾病。
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