China approves Lumirix for mild to moderate atopic dermatitis
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurring symptoms, with the CIC report indicating that China had more than 54 million people living with AD in 2024.
CHINA—China’s National Medical Products Administration (NMPA) has approved ruxolitinib phosphate cream, marketed as Lumirix®, for the treatment of mild to moderate atopic dermatitis (AD) in adults and children aged two years and older.
China Medical System Holdings Limited said its subsidiary, Dermavon Holdings Limited, received approval for the drug’s new drug application (NDA) on September 2, 2026, with the registration certificate issued on September 3.
Dermavon is an innovative pharmaceutical company focused on skin health and is seeking a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited.
The approval covers non-immunocompromised adult and pediatric patients aged two years and older whose mild to moderate AD is not adequately controlled with prescription topical treatments or for whom such therapies are not advisable.
Priority Review Accelerates Approval
The NMPA’s Center for Drug Evaluation (CDE) placed the NDA on its Priority Review List because Lumirix qualifies as a new pediatric drug variety, dosage form and specification that conforms to children’s physiological characteristics.
The priority designation shortened the regulatory review process and accelerated the approval of the AD indication.
Lumirix was first approved in China in January 2026 for the treatment of vitiligo, becoming the country’s first approved topical Janus kinase (JAK) inhibitor for the condition.
The latest approval expands its use to AD, providing a treatment option for children aged two years and older, adolescents, and adults.
Phase III Trial Shows Efficacy and Safety
The approval was supported by data from a randomized, double-blind, placebo-controlled phase III clinical trial conducted in China among patients with mild to moderate AD.
At week eight, 63.0% of patients treated with Lumirix achieved an Investigator’s Global Assessment (IGA) score of 0 or 1, with at least a two-grade improvement from baseline, compared with 9.2% of those receiving placebo.
Lumirix also produced stronger results on the Eczema Area and Severity Index (EASI).
At week eight, 78.0% of patients receiving the treatment achieved at least a 75% improvement from baseline (EASI 75), compared with 15.4% in the placebo group.
Most treatment emergent adverse events were mild or moderate, and none resulted in treatment discontinuation. The company reported that Lumirix was generally well tolerated.
Dermavon Expands Skin Health Portfolio
AD is a chronic inflammatory skin disease characterized by recurring symptoms, with the CIC report indicating that China had more than 54 million people living with AD in 2024.
Dermavon has developed a broader skin health portfolio covering treatment and daily care.
Its pipeline includes Lumirix for mild to moderate AD, Comekibart Injection for moderate to severe AD, CMS D001, an oral targeted therapy in phase II development, and the Heling Soothing Product Series for daily skin repair.
The company also expects the expanded use of Lumirix to complement its dermatology portfolio, including ILUMETRI (tildrakizumab injection), Hirudoid (mucopolysaccharide polysulfate cream), other medicines in development, and dermatological skincare products.
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