SHENZHEN, Nov 4, 2026 – (ACN Newswire) – China Medical System Holdings Limited (“CMS” or the “Group”) is delighted to reveal that its subsidiary, Rxilient Medical got 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 participation in grownups and teenagers from 12 years of age. It is the very first and just topical prescription drug in Singapore that straight targets the pathophysiological system of vitiligo[1]satisfying an enduring unmet scientific requirement.
This approval fills a space in the field of vitiligo treatment in Singapore. In addition to Singapore, Rxilient Medical has actually currently introduced sales of Lumirix ® (vitiligo indicator) in Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan Region.
Considering that 2022, the Group has actually released its “Industry Internationalization” technique, utilizing Singapore as its organization center in emerging markets to construct an extremely effective and collective worth loop throughout the whole market chain of “R&D, production, and sales.” Rxilient Medical is the Group’s commercialization subsidiary for going into emerging markets. With “worldwide localization” as its core method, it is dedicated to bringing ingenious worldwide treatments to emerging markets and benefiting regional clients through its full-chain commercialization abilities covering drug import, advancement, registration, and marketing. Rxilient Medical is run by an expert and extremely skilled localized group. Headquartered in Singapore, the business has actually developed subsidiaries or workplaces 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 actually attained sales for a cumulative overall of 9 items throughout numerous nations and areas in Southeast Asia, and had actually cumulatively sent marketing applications for more than 20 pharmaceutical items and medical gadgets, drawing up a robust and constant item launch plan.
About Vitiligo
Vitiligo is a persistent autoimmune illness identified by depigmentation of the skin, which arises from the loss of pigment-producing cells referred to as melanocytes. It is approximated that roughly 0.7% of Singapore’s population experiences vitiligo[2]For years, skin doctors in Singapore have actually counted on treatments such as steroids, calcineurin inhibitors, and phototherapy– treatments that stop working to particularly or effectively target the pathogenesis of vitiligo. The approval of Lumirix ® in Singapore represents the very first drug particularly for the regrowth of pigment in non-segmental vitiligo, filling a space in the field of vitiligo treatment.
More About Ruxolitinib Phosphate Cream
Ruxolitinib phosphate cream (Opzelura ®), an unique cream formula of the selective JAK1/JAK2 inhibitor ruxolitinib established by Incyte, is the very first and only drug authorized for the repigmentation of non-segmental vitiligo by the U.S. Food and Drug Administration (FDA)[3]In the U.S., ruxolitinib phosphate cream is suggested for the topical treatment of non-segmental vitiligo in adult and pediatric clients aged 12 years and older, and for the short-term and non-continuous persistent treatment of moderate to moderate atopic dermatitis (ADVERTISEMENT) in non-immunocompromised clients aged 2 years and older whose illness is not well managed with topical prescription treatments, or when those treatments are not suggested. In Europe, ruxolitinib phosphate cream is authorized for the treatment of non-segmental vitiligo in grownups and teenagers aged 12 years and older with facial participation, and moderate atopic dermatitis in grownups whose illness stays improperly managed regardless of treatment with topical corticosteroids and topical calcineurin inhibitors[4]
In January 2026, ruxolitinib phosphate cream was authorized for marketing by the National Medical Products Administration (NMPA) of China, ending up being the very first topical JAK inhibitor authorized in China for the treatment of vitiligo, and has actually considering that been advertised in China. Consequently, in September 2026, the Product was authorized for an extra sign of moderate to moderate atopic dermatitis (“ADVERTISEMENT”), for the topical short-term and non-continuous persistent treatment of moderate to moderate advertisement in non-immunocompromised adult and pediatric clients 2 years of age and older whose illness is not properly managed with other topical treatments or when those treatments are not suggested. This more broadens the Product’s application in the field of skin-related illness.
In 2 similar Phase III double-blind, randomized, placebo-controlled research studies (TRuE-V1 and TRuE-V2) performed overseas, the percentage of clients accomplishing the main effectiveness endpoint of a minimum of 75% enhancement in the Facial Vitiligo Area Score Index (F-VASI 75) after 24 weeks of treatment with ruxolitinib phosphate cream was 29.9% in both research studies, considerably greater than the 7.5% and 12.9% in the placebo groups, respectively. Continued consume to 52 weeks revealed continual repigmentation[5]
The Group, through a subsidiary of Dermavon, participated in a Collaboration and License Agreement with Incyte for ruxolitinib phosphate cream on 2 December 2022, getting an unique license to establish, sign up and advertise the Product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian nations (the “Territory”) and a non-exclusive license to produce the Product in the Territory. The subsidiary of Dermavon has actually sublicensed the pertinent rights for the Product outside Mainland China to the Group (leaving out Dermavon and its subsidiary).
Incyte has around the world rights for the advancement and commercialization of ruxolitinib phosphate cream, marketed in the United States and Europe as Opzelura ®. Opzelura ® and the Opzelura ® logo design are signed up hallmarks of Incyte. Lumirix ® is a signed up hallmark of the Group.
About CMS
CMS is an ingenious pharmaceutical business concentrated on the recognition, structure, and complete lifecycle management of distinguished specialized pharmaceuticals. With a dual-engine technique of internal R&D and collective R&D, and leveraging its core ability to construct markets and brand names from the ground up, CMS allows each medication to completely recognize both its medical worth and industrial worth.
Concentrating on unmet scientific requirements, CMS effectively advances the research study, medical advancement and regulative approval of separated specialized medications. Making use of evidence-based medication and enduring competence throughout specialized restorative locations, CMS develops the medical positioning of its items. Through an expert scholastic promo system, CMS drives scientific acknowledgment and massive application of its items, equating scientific worth into long-lasting brand name competitiveness.
CMS concentrates on specialized locations consisting of cardiovascular-kidney-metabolic, main nerve system, gastroenterology, ophthalmology, and skin health. It constantly broadens its item portfolio, cultivating a tiered structure of marketed items and ingenious pipeline prospects, and leverages its strong medical proficiency and omni-channel commercialization network to drive the development of brand-new items. Within the Group, its skin health organization, Dermavon, has actually become a leading ingenious pharmaceutical business in China’s skin health sector. CMS is broadening its worldwide organization with Southeast Asia as a base, advancing item intro, registration and commercialization in line with regional health care requirements, while gradually enhancing its local production footprint to reinforce localized operations and supply abilities.
Referral:
2. Chan MF, Thng S. et al. Examining elements related to lifestyle of vitiligo clients in Singapore, International Journal of Nursing Practice 2013; 19 (Suppl. 3), 3– 10
3. The U.S. FDA approval info can be discovered on the Incyte authorities site, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream
4. The EMA approval info can be discovered on the Incyte authorities site, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-opzelurar
5. The medical research studies info can be discovered on the Opzelura ® main site, as follows: https://www.opzelura.com/opzelura-prescribing-information
CMS Disclaimer and Forward-Looking Statements
This news release is not planned to promote any items to you and is not for marketing functions. This news release does not suggest any drugs, medical gadgets and/or signs. If you wish to know more about the medical diagnosis and treatment of particular illness, please follow the viewpoints or assistance of your physician or other medical and health experts. Any treatment-related choices made by health care specialists ought to be based upon the client’s particular scenarios and in accordance with the drug bundle insert.
This news release which has actually been prepared by CMS does not make up any deal or invite to acquire or subscribe for any securities, and will not form the basis for or be counted on in connection with any agreement or binding dedication whatsoever. This news release has actually been prepared by CMS based upon info and information which it thinks about reputable, however CMS makes no representation or service warranty, reveal or indicated, whatsoever, and no dependence will be put on, the reality, precision, efficiency, fairness and reasonableness of the contents of this news release. Particular matters gone over in this news release might consist of declarations relating to the Group’s market chance and company potential customers that are separately and jointly positive declarations. Such positive declarations are not warranties of future efficiency and go through recognized and unidentified dangers, unpredictabilities and presumptions that are hard to forecast. Any positive declarations and forecasts made by 3rd parties consisted of in this news release are not embraced by the Group and the Company is not accountable for such third-party declarations and forecasts.
Media Contact
Brand Name: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Email:
Site: https://web.cms.net.cn/en/home/
Subject: Press release summary
Source: China Medical System Holdings Limited
Sectors: BioTech, Healthcare & & Pharm, MedTech, Clinical Trials
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