智通财经APP获悉，2月27日，CDE官网显示，诺华(NVS.US)BTK抑制剂瑞米布替尼片(remibrutinib)率先在华申报上市。根据临床试验进展以及财报信息，推测此次申报的适应症为慢性自发性荨麻疹。

据悉，慢性自发性荨麻疹(CSU)是一种不可预测的全身性皮肤病，其特征是皮肤上自发和反复出现风团或血管性水肿，伴有瘙痒和/或疼痛感，持续至少6周。该疾病影响全球约4000万人次，最常见于20-40岁人群，其中女性受影响概率约为男性两倍。CSU有效治疗选择有限，约60%患者在接受抗组胺药一线治疗后无法完全控制病情。

Remibrutinib是一种新型、口服共价不可逆BTK抑制剂，具有非常高的选择性，可快速结合无活性的BTK构象，从而阻止引起瘙痒、荨麻疹/皮疹和肿胀的组胺释放，没有结合的药物则会从体内清除，减少全身暴露，降低毒副作用。

2024年更新的长期数据表明，与安慰剂相比，remibrutinib在第12周所展现的显著的症状改善持续至第24周。按照第52周的评估结果，近半数患者完全没有瘙痒和荨麻疹症状。

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