智通财经APP获悉，5月8日，CDE官网显示，诺华制药(NVS.US)1类新药PIT565获批临床，用于类风湿关节炎。PIT565是一种同类首创的CD3/CD19/CD2三抗，与CD3双抗相比，通过PIT565进行CD2共刺激可以克服T细胞耗竭，并增加患者的应答深度和持续时间。

截图来源：CDE官网

该药最早于24年11月在国内申请临床，25年1月首次获批临床，用于复发性和/或难治性B细胞恶性肿瘤。25年2月再次获批临床，用于系统性红斑狼疮，实现肿瘤到自免的跨界。目前以上两项适应症均已启动临床I期，正在进行患者招募。

截图来源：Insight数据库

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