智通财经APP讯，康哲药业(00867)发布公告，旗下德镁医药有限公司(“德镁医药”，专业聚焦皮肤健康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市)已于2026年2月24日获得中国国家药品监督管理局(NMPA)受理磷酸芦可替尼乳膏(“产品”)轻中度特应性皮炎(“AD”)的新药上市许可申请(NDA)。产品拟用于其他外用药控制不佳或不建议使用时，非免疫功能受损的2岁及以上儿童和成人轻中度特应性皮炎的局部短期和非持续性慢性治疗。且该项NDA因“符合儿童生理特征的儿童用药品新品种、剂型和规格”，已获得NMPA药品审评中心批准纳入优先审评品种名单，有望加快产品AD适应症上市审评进程。
此外，磷酸芦可替尼乳膏已于2026年1月获得NMPA批准上市，成为中国批准的首款且唯一用于白癜风治疗的靶向药。此次增加AD适应症NDA获受理，是产品向多治疗领域拓展的关键里程碑。
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