China Medical System Holdings Limited announced that its subsidiary, Dermavon Holdings Limited (“Dermavon”, an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited) received the approval from the National Medical Products Administration of China (NMPA) for the New Drug Application (NDA) of ruxolitinib phosphate cream (Lumirix) for the treatment of mild to moderate atopic dermatitis (AD). The product is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The NDA for the AD has been approved for inclusion in the Priority Review List by the Center for Drug Evaluation (CDE) of the NMPA based on its qualification as a “new variety, dosage form and specification of pediatric drug that conforms to the physiological characteristics of children”, which effectively shortened the product's review process and accelerated the marketing approval for the AD indication.
From “First Topical JAK Inhibitor” to Indication Expansion, Lumirix Continues to Deliver Clinical Value
In January 2026, Lumirix was approved for marketing by the NMPA, becoming the first topical JAK inhibitor approved in China for the treatment of vitiligo. The approval of this NDA for the additional indication of AD offers a novel treatment option for pediatric patients 2 years of age and older, as well as adolescent and adult AD patients, with safety and efficacy supported by clinical data.
Previously, Lumirix achieved positive results in a randomized, double-blind, placebo-controlled phase III clinical trial in China for mild to moderate AD:
Robust Efficacy: Lumirix successfully met its primary endpoint a significantly higher proportion of patients treated with Lumirix achieved IGA (Investigator's Global Assessment) of 0 or 1 with at least two grades of reduction from baseline at week 8, compared with placebo (63.0 per cent vs 9.2 per cent, P < 0.001). For the key secondary endpoint, the proportion of subjects achieving at least a 75 per cent improvement from baseline in the Eczema Area and Severity Index score (EASI 75) of treatment with Lumirix was also significantly higher than that of the placebo group, at week 8 (78.0 per cent vs 15.4 per cent, P < 0.001).
Favorable Safety Profile: The severity of treatment-emergent adverse events (TEAE) during the treatment period was mostly mild or moderate, with no TEAEs leading to discontinuation of the study drug. Overall, Lumirix was safe and well-tolerated.
