China Medical System Holdings Limited (CMS) has announced that its subsidiary, Dermavon Holdings Limited, has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) of China for ruxolitinib phosphate cream for the treatment of non-segmental vitiligo. This approval grants Dermavon full regulatory authorisation to commercialise the product across Mainland China. The cream is a selective JAK1/JAK2 inhibitor and is currently the first and only drug approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for repigmentation in non-segmental vitiligo.
Vitiligo remains a significant unmet medical need in China, with an estimated 10.3 million patients, including approximately 8.2 million with the non-segmental form. As the first targeted treatment approved in China for this condition, the product represents a major milestone in addressing a long-standing treatment gap. Clinical data from two overseas Phase III studies met their primary endpoints, with 29.9% of patients achieving F-VASI 75 after 24 weeks of treatment, significantly higher than placebo groups. Continued treatment for up to 52 weeks demonstrated sustained repigmentation. Real-world data in China further confirmed consistent efficacy, with secondary endpoints aligning with the primary outcomes and showing continued improvement over time.
In addition, the Phase III clinical trial in China for ruxolitinib phosphate cream in the treatment of mild to moderate atopic dermatitis has shown positive results, and CMS is actively advancing the NDA process for this indication. The product is part of a collaboration and licensing agreement signed with Incyte in December 2022, under which CMS obtained exclusive rights to develop, register and commercialise the product across Mainland China, Hong Kong, Macau, Taiwan and eleven Southeast Asian countries, along with non-exclusive manufacturing rights in the region.
Since beginning independent operations in 2021, Dermavon has demonstrated strong growth momentum and established a leading position in China’s skin health sector. To further unlock its value and growth potential, CMS has proposed a spin-off and separate listing of Dermavon on the Main Board of the Hong Kong Stock Exchange. This reflects CMS’s successful transition towards an innovation-driven business model focused on developing and commercialising first-in-class and best-in-class therapies.
To date, CMS has built a portfolio of approximately 40 innovative products, with six already approved for marketing in China. Supported by a strong and optimised pipeline of innovative and exclusive drugs, the Group is well positioned to sustain its growth momentum. CMS will continue to strengthen its presence in key therapeutic areas including cardiocerebrovascular diseases, central nervous system, gastroenterology, metabolic diseases, ophthalmology and skin health, while expanding access to global innovative therapies. At the same time, the Group is advancing its internationalisation strategy, with Southeast Asia and the Middle East identified as important growth markets, leveraging its strengths in navigating complex regulatory and healthcare systems to drive sustainable, long-term value creation.