China-based Keymed Biosciences Inc., (HKG: 2162) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-IL-4Rα monoclonal antibody (mAb), Kangyueda (stapokibart), to treat chronic rhinosinusitis with nasal polyposis (CRSwNP). This approval follows the NMPA’s endorsement for moderate to severe atopic dermatitis in September this year, marking Kangyueda as the first biologic preparation for use in CRSwNP in China.
CRSwNP and the Role of Stapokibart
Chronic rhinosinusitis with nasal polyps (CRSwNP) is predominantly a type 2 inflammation-mediated disease affecting the nasal mucosa and paranasal sinuses. Stapokibart targets IL-4Rα, blocking both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, and inhibiting Th2 cell differentiation, which effectively reduces the inflammatory response associated with CRSwNP.
Phase III Study Results and Clinical Impact
The results of a Phase III study demonstrated the efficacy of stapokibart in treating CRSwNP. Two weeks after the first administration, nasal polyps significantly reduced in size. After four weeks of treatment, there was a significant restoration of the sense of smell, and nasal symptoms—including nasal congestion, runny nose, and decreased or lost sense of smell—were significantly improved. By the 24th week, 81% of patients achieved a reduction of at least 50% in nasal polyps, and after 52 weeks of treatment, 90% of patients saw the same reduction. The treatment emergent adverse events (TEAEs) were comparable between the stapokibart group and the placebo group, with the majority of TEAEs being mild or moderate, indicating good long-term safety of the drug.-Fineline Info & Tech
