Lumirix® (Ruxolitinib Phosphate Cream) Approved in China for Mild-to-Moderate Atopic Dermatitis
核心洞察
China's NMPA approved Lumirix (搜索)® (ruxolitinib phosphate cream) on 2 September 2026 for mild-to-moderate atopic dermatitis (搜索) in non-immunocompromised adults and pediatric patients aged 2 years and older.
In a Phase III trial, Lumirix (搜索)® met its primary endpoint with 63.0% of patients achieving IGA 0/1 versus 9.2% for placebo (P < 0.001), and EASI 75 in 78.0% versus 15.4% (P < 0.001).
The approval expands Lumirix (搜索)® beyond its January 2026 vitiligo (搜索) indication, making it the first topical JAK inhibitor approved in China for vitiligo.
China Medical System Holdings Limited (搜索) (CMS) announced that its subsidiary, Dermavon Holdings Limited (搜索), received approval from the National Medical Products Administration of China (NMPA) for the New Drug Application (NDA) of ruxolitinib phosphate cream (Lumirix (搜索)®) for the treatment of mild to moderate atopic dermatitis (搜索) (AD) on 2 September 2026, with the drug registration certificate 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 the AD indication was 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." This designation effectively shortened the product's review process and accelerated marketing approval for the AD indication.
From First Topical JAK Inhibitor to Indication Expansion
In January 2026, Lumirix (搜索)® was approved for marketing by the NMPA, becoming the first topical JAK inhibitor approved in China for the treatment of vitiligo (搜索). 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 based on Phase III clinical data from China and overseas.
Phase III Clinical Evidence
Lumirix (搜索)® achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical trial in China for mild to moderate AD. The product successfully met its primary endpoint, with a significantly higher proportion of patients treated with Lumirix® achieving an Investigator's Global Assessment (IGA) 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) was also significantly higher than that of the placebo group at week 8 (78.0% vs 15.4%, P < 0.001).
Regarding safety, 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 (搜索)® was safe and well-tolerated.
Disease Burden and Unmet Need
AD is a chronic, recurrent and inflammatory dermatologic disease, with the main clinical manifestations of dry skin, chronic eczema-like lesions and obvious itching or pruritus, which may seriously affect the quality of life of patients. According to the CIC Report, there were over 54 million AD patients in China in 2024. Based on SCORAD scores, mild to moderate AD accounts for 98% of these cases, representing over 52.5 million patients.
Topical drugs are the most basic treatment for AD. Traditional topical medications such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs) have clinical pain points with long-term adverse reactions or limited efficacy, therefore novel treatments are urgently needed.
Building a "Treatment + Care" Solution
To address the needs of AD patients from treatment to daily care, Dermavon has built a comprehensive "treatment + care" solution spanning multiple modalities: Lumirix (搜索)® (mild-to-moderate AD, marketed in China), Comekibart Injection (moderate-to-severe AD, under NDA review in China), CMS-D001 (moderate-to-severe AD, Phase II clinical trial), and the Heling Soothing Product Series for daily repair (marketed in China).
The indication expansion of Lumirix (搜索)® will strengthen Dermavon's strategic layout in skin treatments and create synergies with its commercialized innovative drug ILUMETRI (tildrakizumab injection), commercialized exclusive drug Hirudoid (mucopolysaccharide polysulfate cream), and a series of innovative drugs under development and dermatological skin care products, in terms of expert network and market resources.
About Ruxolitinib Phosphate Cream
Ruxolitinib phosphate cream is a novel cream formulation of the selective JAK1 (搜索)/JAK2 (搜索) inhibitor ruxolitinib developed by Incyte. Incyte has worldwide rights for the development and commercialization of ruxolitinib phosphate cream, marketed in the United States and Europe as Opzelura®. In the U.S., ruxolitinib phosphate cream is the first topical JAK inhibitor approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of non-segmental vitiligo (搜索) in adult and pediatric patients 12 years of age and older, and for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (搜索) in non-immunocompromised adult and pediatric patients 2 years of age and older.
On 2 December 2022, Dermavon entered into a Collaboration and License Agreement with Incyte for ruxolitinib phosphate cream, obtaining an exclusive license to develop, register and commercialize the product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian countries, and a non-exclusive license to manufacture the product in the Territory.