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China accepted a drug application for ruxolitinib cream to treat eczema in kids and adults, with fast-track review.
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.
The application, submitted on February 24, 2026, benefits from a shortened review timeline of 130 days due to its pediatric formulation.
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.
The treatment was well-tolerated, with no discontinuations due to safety issues.
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.
China aceptó una solicitud de fármaco para la crema de ruxolitinib para el tratamiento del eczema en niños y adultos, con revisión acelerada.