China-based Keymed Biosciences Inc. (HKG: 2162) announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its Kangyueda (stapokibart), an anti-IL-4Rα monoclonal antibody (mAb), this time for its use in seasonal allergic rhinitis. Stapokibart previously gained NMPA approval for the treatment of severe atopic dermatitis in September and chronic rhinosinusitis with nasal polyposis (CRSwNP) in December of last year.
Positive Trial Results
The latest regulatory approval is based on results from a multi-center, randomized, double-blind, placebo parallel controlled Phase III study. The study evaluated the efficacy and safety of stapokibart in adult patients with seasonal allergic rhinitis who had poorly controlled symptoms despite nasal corticosteroids or other treatment methods. Results showed that during the pollen season, after 2 weeks of treatment with stapokibart, patients’ typical nasal allergy symptoms (runny nose, nasal congestion, nasal itching, sneezing) were effectively controlled. Stapokibart also significantly alleviated eye allergy symptoms (itchy/burning eyes, watery/flowing eyes, red eyes), thereby comprehensively improving patients’ quality of life. The drug demonstrated a favorable safety profile.-Fineline Info & Tech
