诺华(NVS.US)三抗新药在中国再获批临床 针对系统性红斑狼疮

智通财经
08 Feb

智通财经APP获悉,中国国家药监局药品审评中心(CDE)官网最新公示,诺华(NVS.US)申报的1类新药PIT565获得一项新的临床试验默示许可,拟开发治疗系统性红斑狼疮(SLE)。公开资料显示,这是诺华在研的一款抗CD3/CD19/CD2的三特异性抗体,此前已经在中国获批针对B细胞恶性肿瘤的IND。

目前,PIT565正处于国际多中心1期研究阶段,针对适应症包括复发或难治性B-NHL和R/R CD19阳性B-ALL,以及系统性红斑狼疮(SLE)。本次PIT565在中国针对SLE适应证获批临床,意味着该药在中国也将进入临床开发阶段。

公开资料显示,PIT565可以靶向恶性B细胞上的CD19,同时可与T细胞上的CD3(TCR信号传导成分)和CD2(一种共刺激受体)结合。与CD3双特异性相比,通过PIT565共刺激CD2可能会克服T细胞衰竭,增加患者反应的深度和持续时间。研究表明,CD2信号传导与非耗竭T细胞表型相关。

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