Keymed Biosciences Inc. announced that Stapokibart (康悦达), an anti-IL-4Rα monoclonal antibody, has been granted marketing approval by the National Medical Products Administration (NMPA) of China for the treatment of moderate-to-severe atopic dermatitis (AD) in adults.
The approval is based on data from a multi-center, randomized, double-blind, placebo-controlled Phase III study. The trial's co-primary endpoints were achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) and an Investigator’s Global Assessment (IGA) score of 0 or 1 with a reduction of ≥2 points from baseline at week 16. The study met both co-primary endpoints, demonstrating sustained clinical benefits and a good safety profile with long-term treatment.
Phase III Trial Results
The Phase III trial evaluated the efficacy and safety of Stapokibart over 52 weeks. At week 52, 92.5% of patients in the Stapokibart group achieved EASI-75, compared to 88.7% in the group that switched from placebo to Stapokibart. EASI-90 response rates were 77.1% and 65.6%, respectively. Furthermore, 67.3% and 64.2% of patients in the respective groups achieved an IGA score of 0 or 1 with a reduction of ≥ 2 points from baseline.
Long-term treatment with Stapokibart consistently improved dermatitis symptoms and quality of life. During the maintenance period, only one subject (0.9%) experienced a relapse. The safety profile of Stapokibart was consistent with that observed at week 16, with no new safety signals identified after 52 weeks of administration.
Mechanism of Action
Stapokibart (CM310) is a humanized, high-affinity antibody targeting the interleukin-4 receptor α-subunit (IL-4Rα). As the first domestically manufactured IL-4Rα antibody drug approved by the NMPA, it works by dually blocking interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, both of which are critical cytokines in type II inflammation.
Future Indications
Keymed Biosciences has also submitted new drug applications for Stapokibart for the treatment of seasonal allergic rhinitis and chronic rhinosinusitis with nasal polyposis, which have been accepted by the NMPA.
