China Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that the Class 1 innovative drug anti-IL-4Rα MG-K10 humanized monoclonal antibody injection (“MG-K10” or the “Product”), for which the Group holds co-development rights (except for atopic dermatitis (AD)) and exclusive commercialization rights, has obtained the Drug Clinical Trial Approval Notice issued by National Medical Products Administration (“NMPA”) on 29 September 2025. The NMPA has agreed to conduct the clinical trial of MG-K10 for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
About MG-K10
MG-K10 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, for the treatment of type 2 inflammatory diseases. Currently marketed anti-IL-4Rα drugs require biweekly dosing, while MG-K10 has a longer half-life, enabling a four-week dosing frequency. It 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).
The Group and Hunan Mabgeek Biotech Co., Ltd. (“Mabgeek Biotech”) are actively preparing to initiate the relevant clinical trials. MG-K10 has also 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. Asthma, prurigo nodularis, and seasonal allergic rhinitis have all entered the Phase III clinical trial stage in China. In the previously completed Phase II clinical trial for adult patients with moderate-to-severe asthma, MG-K10 also demonstrated good efficacy and safety[1]. MG-K10 has also obtained IND approvals for the indications of chronic spontaneous urticaria (CSU) eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps in China.
About Chronic Obstructive Pulmonary Disease (COPD)
COPD is a common chronic airway disease characterized by persistent respiratory symptoms and airflow limitation, including chronic cough, sputum production, and progressive dyspnea. According to The Lancet Respiratory Medicine, COPD affects more than 400 million people and continues to be the third cause of death worldwide[2], posing significant socioeconomic and health burdens. In China, COPD is one of the chronic respiratory diseases of high national concern and has been included as a key prevention and management project in the “Healthy China 2030” initiative[3]. Estimates indicate that the number of COPD patients in China was approximately 104.4 million in 2019, rising to 107.1 million in 2023. Due to exposure to risk factors and an aging population, the incidence of COPD is expected to increase over the coming decades. By 2032, the number is projected to reach 111.4 million[4]. Traditional COPD treatments primarily rely on bronchodilators and corticosteroids[5], but it still fails to fully meet the treatment needs of patients. Some patients still face challenges such as frequent acute exacerbations and progressive decline in lung function[6]. Currently, innovative treatment options for COPD patients in China are limited, with Dupilumab being the only approved innovative therapy for COPD in China.
MG-K10 has the potential to become Best-in-Class. The addition of new indication for COPD will further enhance the Product’s competitiveness. With a long-acting formulation administered once every four weeks dosing, MG-K10 is expected to provide COPD patients with a new, effective, and safe treatment option. Upon approval for marketing, the Product will drive a strategic expansion of the Group’s business scope into the respiratory therapeutics sector. Building upon the existing asthma-focused pipeline, this initiative will extend the Group’s reach into additional respiratory disease areas, accelerating the development and strategic deployment of a diversified respiratory product portfolio. These efforts will deepen market penetration and therapeutic expertise in this field, substantially strengthening the Group’s core competitiveness in respiratory medicine. MG-K10 will provide differentiated treatment options for patients in China, addressing the clinical need for therapies that deliver robust efficacy, favorable safety, and improved treatment adherence, ultimately bringing meaningful value to patients.
On 24 January 2025, the Group through its subsidiaries entered into a Collaboration Agreement with Mabgeek Biotech and its subsidiary for MG-K10. In accordance with the Agreement and supplementary agreements, the Group 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 Holdings Limited 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.
Reference:
- Interim results of the product’s Phase II clinical trial for asthma indication as disclosed by Mabgeek: https://www.mabge.com/index.php?c=show&id=18
- de Oca MM, Perez-Padilla R, Celli B, et al. The global burden of COPD: epidemiology and effect of prevention strategies. Lancet Respir Med. 2025 Aug;13(8):709-724. doi: 10.1016/S2213-2600(24)00339-4.
- National Health Commission et al. Notice on Issuing the Implementation Plan for the Chronic Respiratory Disease Prevention and Control Action of the Healthy China Initiative (2024 – 2030).
- Prospectus of Hunan Mabgeek Biotech Co., Ltd.
- Guidelines for diagnosis, treatment and management of chronic obstructive pulmonary disease in primary care in China (2024). Chinese Journal of General Practitioners, 2024, 23(6): 578-602.
- Chronic Obstructive Pulmonary Disease Group of the Chinese Society of Respiratory Diseases, et al. Guidelines for the diagnosis and treatment of chronic obstructive pulmonary disease (2021 revised edition). Chinese Journal of Tuberculosis and Respiratory Diseases, 2021, 44(3): 170-205.
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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