SHENZHEN, CHINA – China Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that the New Drug Application (NDA) in China for the Seasonal Allergic Rhinitis (SAR) indication of MG-K10 (generic name: Comekibart Injection, “MG-K10” or the “Product”), a Class 1 innovative drug anti-IL-4Rα humanized monoclonal antibody injection, for which the Group holds co-development rights (excluding the indication of atopic dermatitis (AD)) and exclusive commercialization rights, was accepted by the National Medical Products Administration of China (NMPA) on 23 April 2026. The Product is proposed for the treatment of adult patients with moderate-to-severe seasonal allergic rhinitis whose symptoms remain inadequately controlled after treatment with intranasal corticosteroids.
The acceptance of the NDA represents an important milestone for the Group’s ophthalmology business, CMS Vision, as it expands its therapeutic focus from ophthalmology into the field of otolaryngology (ENT). It also marks another significant milestone in the Group’s research and development progress in the field of type 2 inflammatory diseases. If the Product is successfully approved for marketing, the Group will leverage its strong academic promotion capabilities and extensive commercialization network to accelerate the commercialization of the Product. It is also expected to further enhance the academic brand influence of CMS Vision in the relevant specialty areas and provide new momentum for the Group’s business growth.
BIC Potential: Dosing once every 4 weeks; Phase III study met the primary endpoint with a favorable safety profile
MG-K10 is an innovative long-acting anti-IL-4Rα humanized monoclonal antibody that simultaneously blocks the signaling pathways of the key type 2 inflammatory cytokines IL-4 and IL-13, thereby exerting immunomodulatory effects. It is being developed for the treatment of type 2 inflammatory diseases, including seasonal allergic rhinitis, asthma, atopic dermatitis (AD), prurigo nodularis, chronic obstructive pulmonary disease (COPD), chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Currently marketed anti-IL-4Rα therapies require administration once every two weeks. MG-K10, with its longer half-life, enabling a once-every-four-weeks dosing regimen. It therefore has the potential to become the first long-acting anti-IL-4Rα monoclonal antibody to be marketed globally, with the potential to be best-in-class. MG-K10 has met the primary endpoint in a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial in adult patients with moderate-to-severe seasonal allergic rhinitis. The results of the Phase III study demonstrated that the primary endpoint achieved statistical significance, with significantly superior efficacy compared with the placebo group, and a favorable safety profile.
Focusing on Unmet Needs: ~250 million patients; 62% of moderate-to-severe patients remain inadequately controlled; long-acting breakthrough brings new treatment opportunities
Allergic rhinitis is a chronic inflammatory disease of the nasal mucosa mediated by IgE, with type 2 inflammation as the core pathogenic mechanism. It occurs in susceptible individuals upon exposure to environmental allergens such as pollen and dust mites. In recent years, the prevalence of the disease in China has increased from 11.1% to 17.6%, affecting approximately 250 million people[1], among whom 52.2% are patients with persistent moderate-to-severe disease[2]. The disease burden is significant and has become an important public health issue. Current standard treatments, including intranasal corticosteroids and antihistamines, have notable limitations. 62% of patients with moderate-to-severe disease remain inadequately controlled[3]. Long-term use of intranasal corticosteroids may lead to adverse reactions such as epistaxis[4], while antihistamines are often associated with side effects such as drowsiness[5], indicating significant unmet clinical needs. As a biologic therapy targeting IL-4Rα, MG-K10 can block the type 2 inflammatory pathway at its source. Compared with currently approved biologics targeting the same pathway (which require dosing once every two weeks), MG-K10 achieves a differentiated breakthrough in dosing frequency with its long-acting property allowing administration once every four weeks, thereby significantly extending dosing intervals. This may help improve patient treatment adherence and reduce the time and economic burden associated with frequent hospital visits. The Product has the potential to provide a new treatment option for patients with moderate-to-severe disease who respond poorly to conventional therapies, thereby reducing the individual and socio-economic burden associated with the disease.
On 24 January 2025, the Group through subsidiaries of the Company entered into a Collaboration Agreement (“Agreement”) with Hunan Mabgeek Biotech Co., LTD 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.
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 Cardiovascular-Kidney-Metabolic/ 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
- Cheng L, Chen J, Fu Q, et al. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018;10:300‑353.
- Zheng, Ming et al. “Clinical characteristics of allergic rhinitis patients in 13 metropolitan cities of China.” Allergy vol. 76,2 (2021): 577-581. doi:10.1111/all.14561
- White, P et al. “Symptom control in patients with hay fever in UK general practice: how well are we doing and is there a need for allergen immunotherapy?” Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology vol. 28,3 (1998): 266-70. doi:10.1046/j.1365-2222.1998.00237.x
- Rosenblut, A et al. “Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis.” Allergy vol. 62,9 (2007): 1071-7. doi:10.1111/j.1398-9995.2007.01521.x
- Bernstein, Jonathan A et al. “Allergic Rhinitis: A Review.” JAMA vol. 331,10 (2024): 866-877. doi:10.1001/jama.2024.0530
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