CMS (867.HK; 8A8.SG) NDA for AD Indication of Long-acting Anti-IL-4R? Humanized Monoclonal Antibody Injection MG-K10 Accepted in China
MWN-AI** Summary
CMS (867.HK; 8A8.SG) has made significant strides with its innovative drug MG-K10, a long-acting anti-IL-4R? humanized monoclonal antibody injection. As of October 30, 2025, the National Medical Products Administration (NMPA) in China accepted its New Drug Application (NDA) for the treatment of moderate-to-severe atopic dermatitis (AD). This acceptance marks a pivotal point for CMS, as MG-K10 aims to fill a critical gap in treating patients whose conditions are inadequately managed by topical therapies.
MG-K10 distinguishes itself with a four-week dosing schedule, a notable improvement over existing biweekly therapies, which could enhance patient adherence and comfort. Clinical trials, including a Phase III study, demonstrate promising efficacy, showing that 76.6% of participants achieved significant improvement in symptoms after a year of treatment. Safety profiles are encouraging, with adverse events primarily being mild and devoid of serious complications.
The product also holds the promise of addressing other type 2 inflammatory diseases, such as asthma and chronic rhinosinusitis, with ongoing trials expanding its therapeutic reach. CMS has secured co-development rights and exclusive commercialization rights across several regions, including Mainland China and Singapore.
Dermavon Holdings, the holding company for MG-K10, is anticipated to enrich its product portfolio through synergy with existing products targeting dermatological conditions, including ruxolitinib cream and a TYK2 inhibitor. With over 14.5 million moderate-to-severe AD patients in China, MG-K10 represents a significant advancement not only in CMS's pipeline but also in meeting the urgent needs of patients suffering from debilitating skin conditions. This strategic move aligns with CMS's commitment to innovative pharmaceutical solutions, enhancing its position in the healthcare market.
MWN-AI** Analysis
**Market Analysis: CMS (867.HK; 8A8.SG) and MG-K10 for Atopic Dermatitis**
On October 30, 2025, China Medical System Holdings Limited (CMS) announced the acceptance of the New Drug Application (NDA) for MG-K10, a novel long-acting humanized monoclonal antibody targeting IL-4R for atopic dermatitis (AD) treatment. This represents a pivotal moment for CMS, fundamentally enhancing its dermatology portfolio through Dermavon, its innovative subsidiary.
The global dermatology market is evolving, with increasing incidences of conditions like moderate-to-severe AD driving demand for effective solutions. MG-K10 distinguishes itself due to its extended dosing regimen—administered every four weeks—an advantage over current biweekly alternatives. This improvement is poised to significantly enhance patient adherence, filling a crucial gap in treatment options for over 14.5 million patients projected in China, corresponding to a considerable unmet clinical need.
The Phase III clinical trial results are promising, indicating robust efficacy and favorable safety profiles. Notably, 94.3% of participants showcased at least a 75% reduction in disease severity (EASI 75), positioning MG-K10 as a potential best-in-class solution.
Moreover, MG-K10's broader therapeutic potential in type 2 inflammatory diseases, including asthma and chronic prurigo, underscores CMS's strategic focus on rapidly growing therapeutic areas. Partnerships like the recent agreement with Hunan Mabgeek Biotech bolster CMS's position, enhancing its commercialization capabilities across Asia.
Investors should monitor CMS’s stock closely, as successful regulatory outcomes and market introductions of MG-K10 are likely to catalyze share price appreciation. The company's robust pipeline and strategic focus on launching complementary products will further solidify its market leadership.
In summary, CMS stands poised to capitalize on the unmet needs in AD treatment, establishing a comprehensive therapeutic framework whilst enhancing shareholder value through its innovative product strategy.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SHENZHEN, CHINA, Oct. 30, 2025 (GLOBE NEWSWIRE) -- 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-4R? 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-4R? 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-4R? 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-4R? 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:
- China Insights Consultancy. Industry report on global and China Dermatology Treatment and Care Industry
- 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.
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 does the approval of MG-Kby the National Medical Products Administration impact the market positioning of China Medical Sys Hldgs CHSYF in the dermatology sector, especially considering its unique long-acting formulation?
What strategies will China Medical Sys Hldgs CHSYF implement to enhance patient adherence and market penetration for MG-K10, given its potential to meet the significant unmet needs in moderate-to-severe atopic dermatitis treatment?
With MG-K10's successful Phase III clinical trial and promising safety profile, how does China Medical Sys Hldgs CHSYF plan to leverage this data to attract investors and secure its independent listing on the Main Board of the Stock Exchange of Hong Kong?
How does China Medical Sys Hldgs CHSYF intend to capitalize on the synergies between MG-K10 and its existing dermatological products, like ruxolitinib cream and the TYK2 inhibitor, to create a comprehensive treatment solution in the skin health market?
**MWN-AI FAQ is based on asking OpenAI questions about China Medical Sys Hldgs (OTC: CHSYF).
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