CMS (867.HK; 8A8.SG) NDA for AD Indication of Long-acting Anti-IL-4Ra Humanized Monoclonal Antibody Injection MG-K10 Accepted in China

SHENZHEN, Oct 30, 2025 – (ACN Newswire via SeaPRwire.com) – China Medical System Holdings Limited (“CMS”) is pleased to announce that its subsidiary, 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 of CMS on 22 April 2025 for details) together with its subsidiaries, holds co-development rights (except for atopic dermatitis (AD)) and exclusive commercialization rights for the Class 1 innovative drug anti-IL-4Rα MG-K10 humanized monoclonal antibody injection (“MG-K10” or the “Product”). The New Drug Application (“NDA”) has been accepted by National Medical Products Administration (“NMPA”) on 30 October 2025. The product is intended for the treatment of adult with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

MG-K10 (generic name: Comekibart Injection) is an innovative long-acting anti-IL-4Rα humanized monoclonal antibody that simultaneously blocks the signaling of key type 2 inflammatory cytokines IL-4 and IL-13. With a longer half-life, the Product enables a four-week dosing frequency (currently marketed anti-IL-4Rα drugs require biweekly dosing), which is expected to improve patient adherence. MG-K10 is expected to become the world’s first long-acting anti-IL-4Rα monoclonal antibody to be launched on the market, and has the potential to become the Best-in-Class (BIC).

MG-K10 has achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical study in adults with moderate-to-severe AD, meeting the primary research endpoint as designed, and at 52 weeks of treatment with MG-K10, proportion of participants with Investigator Global Assessment (IGA) score of 0 or 1, also with an improvement of ≥2 points from baseline is 76.6%; proportion of participants with ≥75% reduction in Eczema Area and Severity Index (EASI 75) from baseline is 94.3 %; proportion of participants with ≥90% reduction in Eczema Area and Severity Index (EASI 90) from baseline is 79.1 %. Regarding safety, most of the Treatment Emergent Adverse Event (TEAE) were Grade 1-2, with no Adverse Event of Special Interest (AESI) or fatal adverse event occurred. The incidence of common adverse reactions (conjunctivitis, injection site reactions, etc.) of drugs with the same target is relatively low for MG-K10.

The Product has the potential for the treatment of other type 2 inflammatory diseases, such as asthma, prurigo nodularis, seasonal allergic rhinitis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Among them, asthma, prurigo nodularis and seasonal allergic rhinitis have all entered the phase III clinical trial stage in China.

If MG-K10 is approved, it will provide a new, effective, and safe systemic treatment option for 14.5 million patients with moderate-to-severe AD[1]. Furthermore, MG-K10 will generate synergy with Dermavon’s ruxolitinib cream (for mild to moderate AD), the oral small molecule TYK2 inhibitor CMS-D001 (for moderate to severe AD), and dermatology-grade skincare products of Heling soothing product series, establishing a comprehensive solution for AD that covers various administration routes (injection, oral, and topical) and addresses multiple needs in “treatment + care”, benefiting a wide range of AD patients. Concurrently, it will further enrich Dermavon’s product portfolio in the field of dermatological treatment and reinforce its leading position in skin health sector.

On 24 January 2025, CMS through its subsidiaries entered into a Collaboration Agreement (“Agreement”) with Hunan Mabgeek Biotech Co., LTD and its subsidiaries for MG-K10. In accordance with the Agreement and supplementary agreements, CMS has obtained the co-development rights (excluding AD) and exclusive commercialization rights for the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan Region and Singapore; its subsidiary Dermavon has obtained, through its subsidiary, the co-development rights (excluding AD) and exclusive commercialization rights for the Product in the field of dermatological indications in Mainland China.

About AD Indication

MG-K10’s first indication, AD, is a chronic inflammatory skin disease accompanied by severe itching. It is the most burdensome non-fatal skin disease worldwide and also a chronic disease with a relatively high prevalence and significant disease burden in China. It is estimated that there are over 54 million AD patients in China in 2024. Based on SCORAD scores, the proportion of moderate to severe AD in China was 27%, which means there are over 14.5 million patients[1]. Due to the limitations in efficacy and safety of traditional systemic therapies for AD, moderate to severe AD patients often experience delays in systemic treatment initiation, poor compliance, and suboptimal disease control, leaving a significant unmet need in clinical practice[2]. MG-K10, with its extended dosing interval of once every four weeks, is expected to improve patient adherence and provide a new, effective, and safe systemic treatment option for patients with moderate-to-severe AD.

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 in its advantageous specialty fields, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group.

Reference:

1. China Insights Consultancy. Industry report on global and China Dermatology Treatment and Care Industry

2. Chinese Society of Dermatology, China Dermatologist Association. Clinical pathway for the diagnosis and treatment of moderate to severe atopic dermatitis in China (2023): an expert consensus[J]. Chinese Journal of Dermatology, 2023, 56(11): 1000-1007. DOI: 10.35541/cjd.20230247.

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.

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