CMS (00867.HK): Lumirix Wins Singapore Approval as First Vitiligo Cream

NewTimeSpace News: On 3 November 2026, China Medical System Holdings Limited (stock code: 00867) announced that its subsidiary Rxilient Medical received approval from the Health Sciences Authority of Singapore (HSA) on 3 November 2026 for the new drug application of ruxolitinib phosphate cream (Lumirix®) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents aged 12 and above.

The Company said the product is the first and only topical prescription drug in Singapore that directly targets the pathophysiological mechanism of vitiligo, filling a gap in local treatment. Beyond Singapore, Rxilient Medical has launched Lumirix® for the vitiligo indication in Hong Kong, China, Macao, China and Taiwan, China.

Developed by Incyte, ruxolitinib phosphate cream (Opzelura®) is a topical formulation of the selective JAK1/JAK2 inhibitor ruxolitinib. It was approved by China's National Medical Products Administration in January 2026, becoming the first topical JAK inhibitor approved in China for vitiligo, and is already sold in the country; in September 2026 it obtained an additional indication for mild-to-moderate atopic dermatitis. The Group entered into a collaboration and licence agreement with Incyte in December 2022 for exclusive development, registration and commercialisation rights in mainland China, Hong Kong, Macao and Taiwan, China and 11 Southeast Asian countries.

In two identically designed Phase III randomised, double-blind, placebo-controlled studies (TRuE-V1 and TRuE-V2), 29.9% of patients achieved at least 75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI75) at week 24, versus 7.5% and 12.9% in the placebo groups, with repigmentation maintained through week 52. About 0.7% of Singapore's population is estimated to have vitiligo.