Korannusantara.id – Singapore, 30 January 2026, China Medical System Holdings Limited (“China Medical System”, “CMS”, or together with its subsidiaries, the “Group”), is pleased to announce that its subsidiary, Dermavon
Holdings Limited (“Dermavon”), has obtained the New Drug Application (“NDA”) approval for ruxolitinib
phosphate cream (the “Product”) for the treatment of non-segmental vitiligo from the National Medical Products Administration of China (“NMPA”).
The NDA approval grants Dermavon full regulatory authorisation to commercialise the Product for the approved indication across Mainland China.
The Product is a selective JAK1/JAK2 inhibitor and is the first and only drug approved by the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) for the repigmentation in non-segmental vitiligo.
Vitiligo remains a significant unmet medical need in China. It is estimated that there are approximately 10.3 million vitiligo patients in China with non segmental vitiligo patients accounting for approximately 8.2 million.
As the first and only targeted drug approved in China for vitiligo, the Product addresses a long-standing gap in targeted drug treatment and is of great landmark significance.
The Product’s two overseas Phase III clinical studies for vitiligo both met their primary endpoints, with 29.9%
of patients achieving F-VASI 75 after 24 weeks of treatment in both studies, significantly higher than theplacebo groups (7.5% and 12.9%).
Continued use up to 52 weeks showed sustained repigmentation. Additionally, real-world study data in China demonstrated 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
continued to improve with prolonged treatment.
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.
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).
Since commencing independent operations in 2021, Dermavon has demonstrated strong growth
momentum and established a leading position in China’s skin health sector.
To fully unlock its intrinsic value
and growth potential, the Group has announced a proposed spin-off via distribution-in-specie and a separate listing of Dermavon on the Main Board of the Hong Kong Stock Exchange.
Dermavon’s notable achievements reflect CMS’s successful transition toward an innovative product-driven business model that supports sustainable growth. The Group has demonstrated the ability to develop and commercialise First-in-Class and Best-in-Class innovative products. Building on this proven model, CMS intends to replicate this approach and expand growth into broader market beyond China, translating scientific innovation into meaningful clinical value for patients.
As of the announcement date, CMS has developed a portfolio of approximately 40 innovative products, of which six have been approved for marketing in China to date. Supported by an optimised product portfolio focused on innovative and exclusive drugs, the Group is well positioned to sustain its growth momentum going forward.
Moreover, the Group will continue to deepen presence in core specialty areas including cardiocerebrovascular, central nervous system, gastroenterology, metabolic diseases, ophthalmology and skin health, bridging global innovative therapies into broader markets. While steadily translating innovative
product pipeline into real commercial value and continuously replenishing its innovative pipeline, the Group is also progressing its internationalisation strategy.
Southeast Asia and the Middle East remain important growth markets for the Group, where fragmented. regulatory and healthcare systems create high entry barriers that play to CMS’s strengths in
commercialisation. These initiatives collectively position the Group for sustainable and long-term value
creation.
