A single dose provides long-lasting coverage throughout the entire seasonal allergy period - MG-K10, a new drug of Class 1 from Mabgeek Biotech, has received acceptance for its NDA application for the indication of seasonal allergic rhinitis.
2026-04-24 0
Kemeqibart is an innovative, long-acting anti-IL-4Rα humanized monoclonal antibody independently developed by Mabgeek Biotech. It exerts immunomodulatory effects by simultaneously blocking the signaling of IL-4 and IL-13, two key type 2 inflammatory cytokines, and is being developed for the treatment of type 2 inflammatory diseases, including seasonal allergic rhinitis, asthma, atopic dermatitis, prurigo nodularis, chronic obstructive pulmonary disease (COPD), chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.
In October 2025, the first marketing application for Kemeqibart was accepted by the CDE for the treatment of adults with moderate-to-severe atopic dermatitis and is currently under review. Kemeqibart enablesonce-every-four-weeks dosing (whereas all marketed drugs targeting the same pathway are dosed once every two weeks), which may help improve patient adherence. It is expected to become the world’s first marketed long-acting anti-IL-4Rα monoclonal antibody, with best-in-class potential.
The new indication submitted in this application is seasonal allergic rhinitis.Allergic rhinitis is an IgE-mediated chronic inflammatory disease of the nasal mucosa, with type 2 inflammation as its core mechanism. Susceptible individuals develop the disease after exposure to environmental allergens such as pollen and dust mites. Current standard clinical treatments, such as intranasal corticosteroids and antihistamines, have clear limitations: symptoms remain inadequately controlled in 62% of patients with moderate-to-severe disease; long-term use of intranasal corticosteroids may cause epistaxis; and antihistamines are often associated with adverse reactions such as drowsiness. Significant unmet clinical needs therefore remain.
Source: CDE official website
Kemeqibart has met the protocol-defined primary endpoint in a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in adults with moderate-to-severe seasonal allergic rhinitis.Results from this Phase III study showed that the primary endpoint achieved statistical significance, with efficacy significantly superior to placebo and a favorable safety profile.
The marketing application for Kemeqibart in seasonal allergic rhinitis is expected to provide patients with a new treatment option that is effective, safe, and more convenient, with a single administration covering the entire allergy season.