SHENZHEN, CHINA – 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, please refer to the announcement published by the Group on 22 April 2025 for details) received the acceptance from the National Medical Products Administration of China (NMPA) for the New Drug Application (NDA) of ruxolitinib phosphate cream (the “Product”) for the treatment of mild to moderate atopic dermatitis on 24 February 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 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 is expected to accelerate the Product’s review process for marketing approval in the AD indication.
Impressive phase III trial data in AD
Its Priority Review is expected to accelerate its NDA approval
Ruxolitinib phosphate cream was approved for marketing by the NMPA in January 2026, becoming the first and only targeted drug approved in China for the treatment of vitiligo. The acceptance of this NDA for the additional indication of AD marks a key milestone in the Product’s expansion into multiple therapeutic areas.
Ruxolitinib phosphate cream has achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical trial in China for mild to moderate AD.
- Robust Efficacy: The Product successfully met its primary endpoint, demonstrating that a significantly higher proportion of subjects treated with ruxolitinib phosphate cream 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 ruxolitinib phosphate cream 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, ruxolitinib phosphate cream was safe and well-tolerated.
Furthermore, the NDA has been approved for inclusion in the Priority Review List. According to relevant NMPA regulations, the review timeline for marketing applications subject to Priority Review and Approval Procedure is substantially shortened—from the standard 200 days to 130 days. This significant reduction in the review timeline is expected to accelerate the marketing process of ruxolitinib phosphate cream for the AD indication, benefiting a wide range of patients at an earlier date.
Building an integrated AD solution,
strengthening Dermavon’s leadership in dermatology
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. It is estimated that there were over 54 million AD patients in China as of 2024. Based on SCORAD scores, mild to moderate AD accounts for 98% of these cases, representing over 52.5 million patients[1]. 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.
Dermavon has developed a comprehensive “treatment + care” integrated solution for AD. In addition to the topical formulation ruxolitinib phosphate cream for mild-to-moderate AD, the portfolio also includes the injectable biological agent Comekibart Injection (MG-K10) for moderate-to-severe AD, the oral small molecule targeted drug CMS-D001 for moderate-to-severe AD, and the Heling Soothing Product Series for daily repair, to meet the management needs of AD patients from treatment to daily care.
Simultaneously, the acceptance of the NDA for the AD indication will strengthen Dermavon’s strategic layout in the field of 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, thereby potentially enhancing Dermavon’s market competitiveness and brand influence in the field of skin health.
More Information About Ruxolitinib Phosphate Cream
Ruxolitinib phosphate cream (Opzelura®), a novel cream formulation of the selective JAK1/JAK2 inhibitor ruxolitinib developed by Incyte. In China, ruxolitinib phosphate cream is approved for the treatment of non-segmental vitiligo with facial involvement in children aged 12 years and older and adult patients. 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 in patients aged 12 years and older, and 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[2]. In Europe, ruxolitinib phosphate cream is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age[3].
The Group, through its subsidiary of Dermavon entered into a Collaboration and License Agreement with Incyte for ruxolitinib phosphate cream on 2 December 2022, 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 (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory. The subsidiary of Dermavon has sublicensed the relevant rights for the Product outside of Mainland China to the Group (excluding Dermavon and its subsidiary).
Incyte has worldwide rights for the development and commercialization of ruxolitinib phosphate cream, marketed in the United States and Europe as Opzelura®. Opzelura® and the Opzelura® logo are registered trademarks of Incyte.
About CMS
CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.
CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.
CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development in its advantageous specialty fields, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group.
Reference:
1. China Insights Consultancy’s industrial report
2. The U.S. FDA approval information can be found on the Incyte official website, as follows:
3. The EMA approval information can be found on the Incyte official website, as follows:
CMS Disclaimer and Forward-Looking Statements
This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.
This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.
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