SHENZHEN, CHINA – On 12 March 2026, 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) has its innovative prescription medicine ruxolitinib phosphate cream (Lumirix®) (the “Product”, marketed as Opzelura® in the U.S., Europe and Canada) recorded the initial prescriptions for vitiligo patients across 30 provincial-level regions. The prescriptions cover approximately a thousand influential public and private medical institutions in the field of skin health and disease management, including Huashan Hospital, Fudan University, Shanghai Skin Disease Hospital, Dermatology Hospital of Southern Medical University, Second People’s Hospital of Chengdu, The First Bethune Hospital of Jilin University, The Second Xiangya Hospital of Central South University, United Family Healthcare Group, among others*. Meanwhile, the Product has become concurrently accessible via over 1,300 offline drugstores as well as JD.com e-commerce platform. *Hospital rankings are listed in no particular order.
As the first topical JAK inhibitor approved in China for the treatment of vitiligo, ruxolitinib phosphate cream has officially launched its large-scale clinical application today, marking a breakthrough in China’s vitiligo treatment landscape and ushering in a new era of precision targeted therapy for vitiligo. Supported by safety and efficacy fully demonstrated in clinical studies, the Product is expected to bring new hope for repigmentation to millions of vitiligo patients.
The rapid commercialization progress of ruxolitinib phosphate cream underscores strong product operation capabilities of CMS (including Dermavon), while also reflecting the robust supports from China’s regulatory reforms in accelerating patient access to clinically urgently needed innovative drugs. Benefiting from the integrated healthcare ecosystem of the Hainan Free Trade Port and the “Urgently Needed Imported Drugs for Clinical Use” policy, the Product initiated pilot clinical use in August 2023 at Boao Super Hospital within the Boao Lecheng International Medical Tourism Pilot Zone. Pilot usage subsequently expanded to designated medical institutions across the Guangdong–Hong Kong–Macao Greater Bay Area, Beijing-Tianjin region and other regions. In accordance with the relevant regulations of China’s real-world data application pilot project, as well as supported by the Hainan Provincial Medical Products Administration and the Administration of the Boao Lecheng International Medical Tourism Pilot Zone, the Product has accumulated real-world clinical data in China under pilot application, significantly accelerating its clinical, registration and approval timelines. The Product received its Drug Registration Certificate on January 30, 2026 (approval date: January 27, 2026).
Following its approval, in less than 1.5 months (including the Chinese New Year holiday), the initial prescriptions for ruxolitinib phosphate cream have been issued across multiple regions and hospitals, reflecting the highly efficient collaboration and concerted efforts among CMS teams, regulatory authorities and business partners. With robust support from the cross-departmental coordination mechanism of the Beijing Daxing Airport Economic Zone Joint Administrative Committee, once import conditions were met, the Product completed customs clearance approval, sampling and related customs procedures within 24 hours, and obtained the drug testing report within 7 working days, representing efficient execution and acceleration for the innovative drugs in China. During this process, the Beijing Municipal Medical Products Administration proactively provided end-to-end policy guidance; the government service center has efficiently completed customs clearance filing; the Beijing Institute for Drug Control has conducted methodological pre-testing to accelerate timelines for innovative drug, and continuous worked during the Chinese Spring Festival; and Daxing Airport Customs provided specialized pre-guidance on declaration and swiftly completed customs review and release. Through parallel workflows and coordinated execution, all parties collectively pressed the “fast-forward button” for the Product’s commercialization, helping this urgently needed innovative therapy reach patients faster.
As the Product enters the large-scale clinical application stage, it is expected to further strengthen Dermavon’s comprehensive dermatology solutions and brand value. Building on its leadership in skin health, Dermavon will continue to improve accessibility of ruxolitinib phosphate cream to benefit more vitiligo patients and steadfastly safeguard public skin health through innovation.
About Vitiligo
Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, which results from the loss of pigment-producing cells known as melanocytes. The discolored areas usually get bigger with time and the condition could influence skin on any part of the patients’ body. Vitiligo usually affects the appearance of patients, especially on exposed areas such as the face and neck. According to a study that involved over 1,000 diagnosed vitiligo patients, over 45% of patients have facial involvement, and over 20% of patients have neck involvement[1].The obvious presence of white patches may make patients feel that their appearance has been compromised, which in turn materially affects their social life, and is associated with a significantly higher incidence of mental health disorders; accordingly, there is an urgent need for effective treatment options for vitiligo[2].
It is estimated that there are approximately 10.3 million vitiligo patients in China and non-segmental vitiligo patients account for approximately 8.2 million[1]. Existing therapies, such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs), have clinical limitations, with adverse reactions or limited efficacy with long-term use. Ruxolitinib phosphate cream successfully fills the gap in targeted drug treatment for vitiligo and is of great landmark significance.
More Information About Ruxolitinib Phosphate Cream
Ruxolitinib phosphate cream (Opzelura®), a novel cream formulation of the selective JAK1/JAK2 inhibitor ruxolitinib developed by Incyte, is the first and only drug approved for the repigmentation of non-segmental vitiligo by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)[3,4]. In the U.S., the Product is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients aged 12 years and older, and for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised adult and pediatric patients aged 2 years and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not advisable. In Europe, ruxolitinib phosphate cream is approved for the topical treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. In China, besides vitiligo indication, the product’s NDA for the treatment of mild-to-moderate AD in adults and pediatric patients aged 2 years and older is also under regulatory review, which has been included in the Priority Review List and is expected to accelerate the Product’s AD review process for marketing approval.
The Group, through the 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 (excluding territories in which exclusive rights have already been licensed), 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 cardiovascular-kidney-metabolic/ 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:
- China Insights Consultancy’s industrial report
- Wang G, Qiu D, Yang H, Liu W. The prevalence and odds of depression in patients with vitiligo: a meta-analysis[J]. Journal of the European Academy of Dermatology and Venereology, 2018,32(8):1343-1351. DOI:10.1111/jdv.14739.
- 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-us-fda-approval-opzeluratm-ruxolitinib-cream
- The EMA approval information 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
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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