China Medical System (867.HK; 8A8.SG) Positive Results from China Phase 3 Clinical Trial of Innovative Drug Ruxolitinib Cream with AD Indication

SHENZHEN, CHINA, Sept. 28, 2025 (GLOBE NEWSWIRE) -- China Medical System Holdings Limited ("CMS") is pleased to announce that its subsidiaries, Dermavon Holdings Limited ("Dermavon", an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited, please refer to the announcement published by CMS on 22 April 2025 for details) together with its subsidiaries, obtained positive results from the phase 3 clinical trial (the "Trial") of ruxolitinib cream (the "Product") in patients with mild to moderate atopic dermatitis (AD) in China.

The Trial is a randomized, double-blind, placebo-controlled, multi-centre clinical trial, with 192 patients enrolled in total, aiming to evaluate the safety and efficacy of the Product in patients with mild to moderate AD. The leading institution is Shanghai Dermatology Hospital, and the principal investigator is Professor Shi Yuling.

The phase 3 clinical trial of ruxolitinib cream in patients with mild to moderate AD in China met its primary endpoint, demonstrating that a significantly higher proportion of patients treated with ruxolitinib cream achieved IGA (Investigator's Global Assessment) of 0 or 1 with at least two grades of reduction from baseline at week 8, compared with placebo (63.0% vs 9.2%, P<0.001). For the key secondary endpoint, the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index score (EASI 75) of treatment with ruxolitinib cream was also significantly higher than placebo, at week 8 (78.0% vs 15.4%, P<0.001). In terms of safety, the severity of treatment-emergent adverse events (TEAE) during the treatment period was mostly mild or moderate, with no TEAEs leading to discontinuation of the study drug. Overall, the ruxolitinib cream was safe and well-tolerated.

CMS is actively moving forward the Product's new drug application (NDA) in China.

About AD

AD is a chronic, recurrent and inflammatory dermatologic disease, with the main clinical manifestations of dry skin, chronic eczema-like lesions and obvious itching or pruritus, which may seriously affect the quality of life of patients. It is estimated that there are over 54 million AD patients in China by 2024. Based on SCORAD scores, the proportions of mild, moderate, and severe AD in China in 2024 was 73%, 25%, and 2%, respectively^[1]. Topical drugs are the most basic treatment for AD. Traditional topical medications such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs) have clinical pain points with long-term adverse reactions or limited efficacy, therefore novel treatments are urgently needed.

About Ruxolitinib Cream

Ruxolitinib cream (Opzelura^®) is a novel cream formulation made of selective JAK1/JAK2 inhibitor ruxolitinib developed by Incyte (NASDAQ: INCY), which is the first topical JAK inhibitor approved for use in the United States by the U.S. Food and Drug Administration (FDA)^[2]. Ruxolitinib cream is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older and 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 topical prescription therapies or when those therapies are not advisable. The Product is also approved in Europe for the treatment of adolescents and adults from 12 years of age with non-segmental vitiligo with facial involvement.

The NDA for vitiligo indication of the Product has been accepted by the National Medical Products Administration of China (NMPA). Furthermore, the marketing authorization application have been approved in Hong Kong Special Administrative Region and Macau Special Administrative Region, and the Product was approved by the Guangdong Provincial Medical Products Administration through the "Hong Kong and Macau Medicine and Equipment Connect" policy, which officially introduced ruxolitinib cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age, providing a novel treatment option for patients with relevant indication into designated medical institutions in the Mainland of Greater Bay Area.

CMS, through a subsidiary of Dermavon entered into a Collaboration and License Agreement with Incyte for ruxolitinib 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 CMS (excluding Dermavon and its subsidiary).

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

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses. Among them, the skin health business has become a leading enterprise in its field, bringing economies of scale in specialty therapeutic fields. Meanwhile, CMS continuously deepens its business development in Southeast Asia and the Middle East regions, further escorting the sustainable and healthy development.

References:

1. China Insights Consultancy's industrial report
2. Drug 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

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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