SHENZHEN, CHINA – 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]. In the U.S., ruxolitinib phosphate cream is indicated for the topical treatment of non-segmental vitiligo in adult and pediatric patients aged 12 years and older, and for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients aged 2 years and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not advisable. In Europe, ruxolitinib phosphate cream is approved for the treatment of non-segmental vitiligo in adults and adolescents aged 12 years and older with facial involvement, and moderate atopic dermatitis in adults whose disease remains inadequately controlled despite treatment with topical corticosteroids and topical calcineurin inhibitors^[4].

In January 2026, ruxolitinib phosphate cream was approved for marketing by the National Medical Products Administration (NMPA) of China, becoming the first topical JAK inhibitor approved in China for the treatment of vitiligo, and has since been commercialized in China. Subsequently, in September 2026, the Product was approved for an additional indication of mild to moderate atopic dermatitis (“AD”), for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with other topical therapies or when those therapies are not advisable. This further expands the Product’s application in the field of dermatological diseases.

In two identical Phase III double-blind, randomized, placebo-controlled studies (TRuE-V1 and TRuE-V2) conducted overseas, the proportion of patients achieving the primary efficacy endpoint of at least 75% improvement in the Facial Vitiligo Area Score Index (F-VASI 75) after 24 weeks of treatment with ruxolitinib phosphate cream was 29.9% in both studies, significantly higher than the 7.5% and 12.9% in the placebo groups, respectively. Continued use up to 52 weeks showed sustained repigmentation^[5].

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).

Incyte has worldwide rights for the development and commercialization of ruxolitinib phosphate cream, marketed in the United States and Europe as Opzelura^®. Opzelura^® and the Opzelura^® logo are registered trademarks of Incyte. Lumirix^® is a registered trademark of the Group.

About CMS

CMS is an innovative pharmaceutical company focused on the identification, building, and full lifecycle management of differentiated specialty pharmaceuticals. With a dual-engine approach of in-house R&D and collaborative R&D, and leveraging its core capability to build markets and brands from the ground up, CMS enables each medicine to fully realize both its clinical value and commercial value.

Focusing on unmet clinical needs, CMS efficiently advances the research, clinical development and regulatory approval of differentiated specialty medicines. Drawing on evidence-based medicine and long-standing expertise across specialty therapeutic areas, CMS establishes the medical positioning of its products. Through a professional academic promotion system, CMS drives clinical recognition and large-scale application of its products, translating clinical value into enduring brand competitiveness.

CMS focuses on specialty areas including cardiovascular-kidney-metabolic, central nervous system, gastroenterology, ophthalmology, and skin health. It continuously expands its product portfolio, fostering a tiered structure of marketed products and innovative pipeline candidates, and leverages its solid medical expertise and omni-channel commercialization network to drive the growth of new products. Within the Group, its skin health business, Dermavon, has grown into a leading innovative pharmaceutical company in China’s skin health sector. Meanwhile, CMS is expanding its international business with Southeast Asia as a base, advancing product introduction, registration and commercialization in line with local healthcare needs, while progressively optimizing its regional manufacturing footprint to strengthen localized operations and supply capabilities.

Reference:

1.https://www.straitstimes.com/singapore/health/singapore-studying-efficacy-safety-of-vitiligo-drug-that-is-available-here-via-special-access

2.Chan MF, Thng S. et al. Investigating factors associated with quality of life of vitiligo patients in Singapore, International Journal of Nursing Practice 2013; 19 (Suppl. 3), 3–10

3.The U.S. FDA approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream

4.The EMA approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-opzelurar

5.The clinical studies information can be found on the Opzelura^® official website, as follows: https://www.opzelura.com/opzelura-prescribing-information

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

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