CMS disclosed that the China National Medical Products Administration (NMPA) has accepted the marketing authorization application for its Class 1 innovative drug, MG-K10, targeting seasonal allergic rhinitis. The application was officially received on April 23, 2026. MG-K10, a novel long-acting anti-IL-4Rα humanized monoclonal antibody, is intended for the treatment of adult patients with moderate-to-severe seasonal allergic rhinitis whose symptoms are inadequately controlled by intranasal corticosteroids.
The drug functions by blocking the signaling of key type 2 inflammatory cytokines, IL-4 and IL-13, thereby modulating the immune response. It is developed for various type 2 inflammatory diseases, including seasonal allergic rhinitis, asthma, atopic dermatitis, prurigo nodularis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Currently available anti-IL-4Rα therapies require dosing every two weeks. In contrast, MG-K10, with its extended half-life, allows for a four-week dosing interval, positioning it as a potential first-in-class long-acting anti-IL-4Rα monoclonal antibody with best-in-class potential.
MG-K10 has successfully met the primary endpoints in a Phase III multicenter, randomized, double-blind, placebo-controlled clinical trial involving adults with moderate-to-severe seasonal allergic rhinitis. The trial results demonstrated statistically significant improvements compared to the placebo group, alongside a favorable safety profile.
Seasonal allergic rhinitis is a chronic inflammatory condition of the nasal mucosa, mediated by IgE and driven by type 2 inflammation, triggered in susceptible individuals by exposure to allergens such as pollen and dust mites. The prevalence of this disease in China has risen from 11.1% to 17.6% in recent years, affecting approximately 250 million individuals. Among them, 52.2% suffer from persistent moderate-to-severe symptoms, highlighting a substantial disease burden and a significant public health challenge. Current standard treatments, including intranasal corticosteroids and antihistamines, have notable limitations. About 62% of patients with moderate-to-severe disease do not achieve adequate symptom control. Long-term use of nasal steroids can lead to side effects like epistaxis, while antihistamines are often associated with drowsiness, indicating a significant unmet clinical need.
As a biologic targeting IL-4Rα, MG-K10 blocks the type 2 inflammatory pathway at its source. Its key differentiator is the extended dosing frequency—once every four weeks—compared to existing approved biologics in the same class, which are administered every two weeks. This longer interval is expected to enhance patient compliance and reduce the time and economic costs associated with frequent medical visits. MG-K10 offers a promising new therapeutic option for patients with moderate-to-severe disease inadequately managed by conventional treatments, potentially alleviating both individual and socioeconomic burdens.
The acceptance of the marketing application for MG-K10 in seasonal allergic rhinitis marks a significant expansion for CMS's ophthalmology subsidiary, CMS We Sheng, into the otorhinolaryngology therapeutic area. It also represents an important milestone in the group's research and development efforts within the type 2 inflammatory disease landscape. Should the product receive marketing approval, CMS plans to leverage its robust academic promotion capabilities and extensive distribution network to accelerate commercialization. This initiative is expected to further enhance the academic brand influence of CMS We Sheng in relevant specialty fields and generate new growth momentum for the group.
On January 24, 2025, CMS, through its subsidiary, entered into a collaboration agreement with Hunan Mage Biotech and its affiliates concerning MG-K10. Under this agreement, CMS secured co-development rights (excluding atopic dermatitis) and exclusive commercialization rights for the product in Mainland China, Hong Kong SAR, Macao SAR, Taiwan region, and Singapore. Specifically, Demei Pharmaceutical, a subsidiary of the group, obtained co-development rights (excluding atopic dermatitis) and exclusive commercialization rights for dermatological indications of the product in Mainland China.
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