SHENZHEN, CHINA, Sept. 03, 2026 (GLOBE NEWSWIRE) -- 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:
- Topical formulation: Lumirix® (mild-to-moderate AD) – Marketed in China
- Injectable biological agent: Comekibart Injection (moderate-to-severe AD) – Under NDA review in China
- Oral small molecule targeted drug: CMS-D001 (moderate-to-severe AD) – Phase II clinical trial
- Daily repair: Heling Soothing Product Series – Marketed in China
Simultaneously, the indication expansion of Lumirix® 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.
About AD
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.
More Information About Ruxolitinib Phosphate Cream
Ruxolitinib phosphate cream is a novel cream formulation of the selective JAK1/JAK2 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®. Opzelura® and the Opzelura® logo are registered trademarks of Incyte. 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 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 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, as well as the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate[3,4].
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 (the “Territory”) and a non-exclusive license to manufacture the product in the Territory. Dermavon has sublicensed the relevant rights for the product outside of Mainland China to the Group (excluding Dermavon).
About CMS
CMS is an innovative pharmaceutical company focused on the identification, building, and full lifecycle management of differentiated specialty pharmaceuticals. With a dual-engine approach of in-house R&D and collaborative R&D, and leveraging its core capability to build markets and brands from the ground up, the Group enables each medicine to fully realize both its clinical value and commercial value.
CMS has established an end-to-end capability loop across the full product lifecycle—precisely identifying quality innovation targets, matching them with optimal development pathways, and efficiently advancing clinical development and registration; developing medical strategies aligned with clinical needs, and driving scaled clinical adoption through a professional academic promotion system and network.
CMS focuses on advantaged specialties including cardiovascular-kidney-metabolic, central nervous system, gastroenterology, ophthalmology, and skin health. Through professional academic promotion and academic resources across multiple disease areas, CMS has built sustainable scale advantages in specialties, with its skin health business becoming a leading player in its segment. Meanwhile, CMS continues to strengthen its international replication capabilities, validating the transferability of its business model in emerging markets such as Southeast Asia and the Middle East, and injecting long-term momentum for the Group’s high-quality, sustainable development.
References
1.China Insights Consultancy’s industrial report
2.The U.S. FDA approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-additional-fda-approval-opzelurar-ruxolitinib
3.The EMA approval information for vitiligo indication can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-opzelurar
4.The EMA approval information for AD indication can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/opzelurar-ruxolitinib-cream-becomes-first-steroid-free-topical
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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