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 approval from the National Medical Products Administration of China (NMPA) on 30 January 2026 for the New Drug Application (NDA) of ruxolitinib phosphate cream (the “Product”) for the treatment of non-segmental vitiligo with facial involvement in children aged 12 years and older and adult patients. It is the first and only targeted drug approved in China for vitiligo, addressing a significant unmet clinical need.

Ruxolitinib phosphate cream is the first and only drug approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for repigmentation in nonsegmental vitiligo^[1,2]. Prior to receiving formal NDA approval, the Group benefited from the “Early and Pilot Implementation” policy granted to the Hainan Free Trade Port and Lecheng Pilot Zone (“Lecheng Pilot Zone”), the “Hong Kong and Macau Medicine and Equipment Connect” policy, and the clinically urgently needed imported drug policies of the Beijing and Tianjin Free Trade Zones, and had already initiated the pilot application of ruxolitinib phosphate cream. Currently, Boao Super Hospital has prescribed ruxolitinib phosphate cream to over 7,000 patients with non-segmental vitiligo, and more than twenty hospitals in Guangzhou, Shenzhen, Dongguan, Foshan, Zhongshan, Zhuhai, Jiangmen, Huizhou, Beijing and Tianjin have provided prescription services for the Product, demonstrating its clinical potential.

The product has shown positive results in both overseas clinical studies and the real-world study in China: in two identical Phase III double-blind, randomized, placebo-controlled studies (TRuE-V1 and TRuE-V2) conducted overseas, the proportion of patients achieving the primary efficacy endpoint of at least 75% improvement in the Facial Vitiligo Area Score Index (F-VASI 75) after 24 weeks of treatment with ruxolitinib phosphate cream was 29.9% in both studies, significantly higher than the 7.5% and 12.9% in the placebo groups, respectively. Continued use up to 52 weeks showed sustained repigmentation^[3]. In accordance with the relevant regulations of the Lecheng Pilot Zone’s real-world data application pilot project, ruxolitinib phosphate cream underwent real-world study in China, demonstrating positive efficacy consistent with the results of overseas pivotal clinical studies. All secondary efficacy endpoints in both domestic and overseas clinical studies showed a benefit trend consistent with the primary efficacy endpoint, and the treatment effect for vitiligo continued to improve with prolonged treatment. Furthermore, according to safety monitoring data from the Lecheng Pilot Zone, no new safety event was identified, no adverse event (AE) leading to discontinuation or withdrawal of treatment occurred, and no study drug-related serious adverse event (SAE) occurred.

This approval in vitiligo brings new hope for treatment to over 10 million vitiligo patients in China, addressing urgent clinical needs. At the same time, it will add to Dermavon’s product portfolio in the field of skin treatment, potentially synergizing with Dermavon’s 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 position in the field of skin health.

Furthermore, the Phase III clinical trial in China of ruxolitinib phosphate cream for the treatment of mild to moderate atopic dermatitis (AD) has achieved positive results. Currently, the Group is actively advancing the NDA for ruxolitinib phosphate cream for the treatment of AD in China, which, if approved, will provide a new treatment option for a broader patient population with AD in China.

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. 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^[4]. 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. The NDA approval of ruxolitinib phosphate cream successfully fills the gap in targeted drug treatment for vitiligo and is of great landmark significance. 

More About Ruxolitinib Phosphate Cream

Ruxolitinib phosphate cream (Opzelura^®), a novel cream formulation of the selective JAK1/JAK2 inhibitor ruxolitinib developed by Incyte, is approved for the topical treatment of nonsegmental vitiligo in adult and patients aged 12 years and older, and for the short-term and non-continuous chronic treatment of mild to moderate AD in patients aged 2 years and older without immunodeficiency in the U.S. 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.

The Group, through a 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 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. 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

2. 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

3. The clinical studies information can be found on the Opzelura^® official website, as follows:

https://www.opzelura.com/opzelura-prescribing-information

4. China Insights Consultancy’s industrial report

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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