China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that its subsidiary, Rxilient Medical received approval from the Health Sciences Authority of Singapore (HSA) on 3 November 2026 for the New Drug Application (NDA) of ruxolitinib phosphate cream (the “Product” or “Lumirix®”) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. It is the first and only topical prescription drug in Singapore that directly targets the pathophysiological mechanism of vitiligo[1], meeting a long-standing unmet clinical need.This approval fills a gap in the field of vitiligo treatment in Singapore. In addition to Singapore, Rxilient Medical has already launched sales of Lumirix® (vitiligo indication) in Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan Region.
Since 2022, the Group has launched its “Industry Internationalization” strategy, using Singapore as its business hub in emerging markets to build a highly efficient and collaborative value loop across the entire industry chain of “R&D, production, and sales.” Rxilient Medical is the Group’s commercialization subsidiary for entering emerging markets. With “global localization” as its core strategy, it is committed to bringing innovative global therapies to emerging markets and benefiting local patients through its full-chain commercialization capabilities covering drug import, development, registration, and marketing. Rxilient Medical is operated by a professional and highly experienced localized team. Headquartered in Singapore, the company has established subsidiaries or offices in Hong Kong Special Administrative Region, Taiwan Region, Malaysia, Vietnam, the Philippines, Indonesia, Thailand, and the UAE. By the end of June 2026, Rxilient Medical had achieved sales for a cumulative total of 9 products across multiple countries and regions in Southeast Asia, and had cumulatively submitted marketing applications for more than 20 pharmaceutical products and medical devices, mapping out a robust and continuous product launch blueprint.
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 approximately 0.7% of Singapore's population suffers from vitiligo[2]. For decades, dermatologists in Singapore have relied on treatments such as steroids, calcineurin inhibitors, and phototherapy — therapies that fail to specifically or adequately target the pathogenesis of vitiligo. The approval of Lumirix® in Singapore represents the first drug specifically for the regeneration of pigment in non-segmental vitiligo, filling a gap in the field of vitiligo treatment.
More 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)[3].
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