China Medical System (867.HK; 8A8.SG) Positive Results from China Phase 3 Clinical Trial of Innovative Drug Ruxolitinib Cream with AD Indication
MWN-AI** Summary
China Medical System Holdings Limited (CMS) recently announced encouraging results from a Phase 3 clinical trial of ruxolitinib cream for atopic dermatitis (AD), a chronic skin condition affecting millions of patients in China. Conducted with 192 patients at the Shanghai Dermatology Hospital, the trial demonstrated that 63% of participants using ruxolitinib cream achieved an Investigator's Global Assessment (IGA) of 0 or 1—indicating clear or almost clear skin—compared to just 9.2% in the placebo group (P<0.001). Additionally, 78% of patients met the key secondary endpoint of a 75% improvement in their Eczema Area and Severity Index (EASI) score by week 8, significantly outpacing the placebo group’s 15.4%.
The trial confirmed that ruxolitinib cream was safe and well-tolerated, with treatment-emergent adverse events being mostly mild or moderate, and no participants discontinued the treatment due to adverse effects. This positive outcome positions CMS to expedite the new drug application (NDA) process in China for ruxolitinib cream, which is jointly developed with Incyte—its worldwide partner in the commercialization of topical JAK inhibitors.
Atopic dermatitis is characterized by severe itching and eczema-like lesions, impacting the quality of life for an estimated 54 million patients in China. Traditional treatments often face limitations, underscoring the need for innovative solutions like ruxolitinib. Approved in the U.S. and Europe for various indications, the cream now presents a potential breakthrough for patients inadequately treated by existing options.
CMS focuses on innovative, first-in-class therapies and has established itself as a leader in the skin health business, actively expanding its presence throughout Southeast Asia and the Middle East.
MWN-AI** Analysis
China Medical System Holdings Limited (867.HK) has recently reported positive results from its Phase 3 clinical trials for ruxolitinib cream, targeting mild to moderate atopic dermatitis (AD), a condition affecting over 54 million patients in China. This promising development not only highlights the efficacy of ruxolitinib compared to placebo but also underscores the company's commitment to addressing significant gaps in dermatological treatments, particularly for conditions resistant to traditional therapies.
The trial results revealed that 63% of patients treated with ruxolitinib achieved a significant reduction in disease severity after eight weeks, compared to just 9.2% in the placebo group. This strong efficacy, combined with a favorable safety profile—where no severe adverse effects led to treatment discontinuation—positions CMS well within the competitive landscape of innovative dermatological therapies.
Investors should view these developments positively, as successful outcomes from clinical trials often lead to stronger market confidence and potential price appreciation for stocks. With CMS preparing a New Drug Application (NDA) in China, this is an opportune time for positioning in the stock. Given that the company’s ruxolitinib cream is already making waves in broader markets, including approvals in Hong Kong and Macau, investors might consider the stock as a strategic addition to their portfolio, especially focused on health care and pharmaceutical innovations.
Furthermore, with CMS's expansion efforts in Southeast Asia and its robust commercialization capabilities in specialty therapeutic areas, the company appears well-positioned for growth. Market dynamics in the dermatology sector, driven by the need for new solutions against conditions like AD, indicate a favorable trajectory for CMS. Therefore, maintaining or increasing holdings in CMS could prove beneficial as it capitalizes on this momentum and expands its innovative treatment offerings.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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 prima r y 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 R uxolitinib C ream
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.
Reference s :
- China Insights Consultancy’s industrial report
- 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.
Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Email: ir@cms.net.cn
Website: https://web.cms.net.cn/en/home/
FAQ**
How are the positive results from the Phase 3 trial for ruxolitinib cream potentially influencing the future stock performance of China Medical Sys Hldgs CHSYF?
What competitive advantages does China Medical Sys Hldgs CHSYF have in the dermatology market in China, particularly with the introduction of ruxolitinib cream?
Given the anticipated growth in the prevalence of atopic dermatitis in China, how might this impact the strategic direction of China Medical Sys Hldgs CHSYF?
What are the potential risks that could affect the approval timeline and commercialization of ruxolitinib cream for China Medical Sys Hldgs CHSYF?
**MWN-AI FAQ is based on asking OpenAI questions about China Medical Sys Hldgs (OTC: CHSYF).
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