CMS (00867): Marketing Authorization Application for Innovative Drug Ruxolitinib Phosphate Cream Approved in Singapore

date
06:37 04/11/2026
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GMT Eight
CMS (00867): Marketing Authorization Application for Innovative Drug Ruxolitinib Phosphate Cream Approved in Singapore China Medical System (00867) announced that Rxilient Medical, a subsidiary of the Group, obtained approval from the Health Sciences Authority of Singapore (HSA) on November 3, 2026 for the new drug application (NDA) of Ruxolitinib Phosphate Cream (the "Product" or "Lumirix") for the indication of vitiligo. The Product is indicated for the treatment of non-segmental vitiligo with facial involvement in adolescents and adults aged 12 years and older. It is the first and only topical prescription drug in Singapore that directly targets the pathophysiological mechanism of vitiligo, addressing long-term unmet clinical needs.
CMS (00867) announced that Rxilient Medical, a subsidiary of the group, obtained approval from the Health Sciences Authority of Singapore (HSA) on November 3, 2026 for the New Drug Application (NDA) of Ruxolitinib Phosphate Cream (the "Product" or "Lumirix") for the vitiligo indication. The Product is indicated for the treatment of non-segmental vitiligo with facial involvement in adolescent and adult patients aged 12 years and older. It is Singapore's first and only topical prescription drug that directly targets the pathophysiological mechanism of vitiligo, addressing long-standing unmet clinical needs. This approval fills a gap in the vitiligo treatment landscape in Singapore. In addition to Singapore, as of now, Rxilient Medical has driven the official launch of sales of Lumirix (vitiligo indication) in the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and the Taiwan region. CMS launched its "industrial internationalization" strategy in 2022, using Singapore as the business hub for emerging markets to build a highly efficient, synergistic value loop across the entire industry chain of "research, 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 global innovative therapies to emerging markets to benefit local patients through full-chain commercialization capabilities covering drug introduction, development and registration, and marketing promotion.