China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce 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”) on 2 September 2026. The drug registration certificate was obtained on 3 September 2026. 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 indication 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, 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% vs 9.2%, P < 0.001). For the key secondary endpoint, the proportion of subjects achieving at least a 75% 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% vs 15.4%, 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.
*Based on Phase III clinical data from China and overseas.
Building the AD “treatment + care” Solution to Strengthen Dermavon's Skin Health Layout
AD is a chronic, recurrent and inflammatory dermatologic disease. According to CIC Report, there were over 54 million AD patients in China in 2024[1]. To address the needs of AD patients from treatment to daily care, Dermavon has built a comprehensive “treatment + care” solution:
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