中国接受了用于治疗儿童和成人湿疹的鲁克索利提尼布奶油的药物申请,并进行了快速审查. China accepted a drug application for ruxolitinib cream to treat eczema in kids and adults, with fast-track review.

中国的NMPA已接受由Dermavon Holdings开发的Ruxolitinib酸盐奶油的新药申请,用于治疗两岁及以上儿童和成年人的轻度至中度的亚托皮炎,并给予其优先审查. China’s NMPA has accepted the New Drug Application for ruxolitinib phosphate cream, developed by Dermavon Holdings, for treating mild to moderate atopic dermatitis in children aged two and older and adults, granting it priority review. 该申请于2026年2月24日提交,由于儿科配方,缩短了130天的审查时限,使该申请受益匪浅。 The application, submitted on February 24, 2026, benefits from a shortened review timeline of 130 days due to its pediatric formulation. 在中国进行的第三期临床试验的临床数据显示,与安慰剂相比,皮肤明显改善,63%的患者皮肤清洁或几乎清洁,78%的患者皮肤清洁,的严重程度至少减少了75%. Clinical data from a Phase III trial in China showed significant improvement over placebo, with 63% of patients achieving clear or almost clear skin and 78% showing at least 75% reduction in eczema severity. 治疗条件良好,没有因安全问题中断治疗。 The treatment was well-tolerated, with no discontinuations due to safety issues. 该药物已于2026年1月批准用于维蒂利戈,是Dermavon更广泛的皮肤病学组合的一部分,旨在解决皮肤疾病管理方面的未满足需求。 The drug, already approved for vitiligo in January 2026, is part of Dermavon’s broader dermatology portfolio aiming to address unmet needs in skin disease management.