Flash News | Mabgeek Biotech has received the approval notice for the Phase III clinical trial of chronic spontaneous urticaria (CSU)

On September 29, 2025, the innovative monoclonal antibody drug "MG-K10 Humanized Monoclonal Antibody Injection" independently developed by Mabgeek Biotech received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA) of China. The NMPA agreed that MG-K10 could conduct Phase III clinical trials for the treatment of chronic spontaneous urticaria (CSU). Up to now, MG-K10 Humanized Monoclonal Antibody Injection has obtained Drug Clinical Trial Approval Notices for 7 indications.

Source: CDE official website

MG-K10 is an innovative long-acting humanized monoclonal antibody against IL-4Rα, capable of simultaneously blocking the signal transduction of key type 2 inflammatory factors IL-4 and IL-13, and is used for the treatment of type 2 inflammatory diseases. Currently available anti-IL-4Rα drugs all require administration every two weeks, while MG-K10 has a longer half-life and can be administered once every four weeks. It is expected to become the world's first long-acting anti-IL-4Rα monoclonal antibody to be marketed and has the potential to be the best-in-class.

MG-K10 has achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical study for adult patients with moderate to severe atopic dermatitis (AD), reaching the primary endpoint as designed in the protocol.

Moderate to severe asthma, prurigo nodularis and seasonal allergic rhinitis have entered the Phase III clinical trial stage in China.

In the phase II clinical trial of MG-K10 for adult patients with moderate to severe asthma, it demonstrated good efficacy and safety.

The indications of eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps have been approved by the NMPA for clinical trials.