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 to treat non-segmental vitiligo. This approval grants Dermavon full 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 results from two overseas Phase III studies showed that 29.9% of patients achieved F-VASI 75 after 24 weeks of treatment, significantly outperforming placebo groups, with continued improvements observed up to 52 weeks. Real-world data in China further confirmed consistent efficacy and sustained benefits with prolonged use.
In addition to vitiligo, the cream has demonstrated positive results in a Phase III clinical trial in China for the treatment of mild to moderate atopic dermatitis, and CMS is currently progressing the NDA submission for this indication. The product is part of a collaboration and licensing agreement signed with Incyte in December 2022, granting CMS exclusive rights to develop, register and commercialise it across Mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries, along with non-exclusive manufacturing rights in the region.
Since commencing independent operations in 2021, Dermavon has shown strong growth momentum and established a leading position in China’s skin health sector. To unlock further value, 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 strengthened pipeline and focus on key therapeutic areas such as cardiocerebrovascular diseases, central nervous system, gastroenterology, metabolic diseases, ophthalmology and skin health, the Group is well positioned for sustained growth. CMS is also advancing its international expansion strategy, with Southeast Asia and the Middle East identified as key growth markets, leveraging its strengths in navigating complex regulatory and healthcare systems to deliver innovative treatments to a broader patient population.
