Keymed Biosciences has announced that Stapokibart (Kangyueda), an anti-IL-4Rα monoclonal antibody, has received approval from the National Medical Products Administration (NMPA) of China for two indications: seasonal allergic rhinitis and chronic rhinosinusitis with nasal polyposis (CRSwNP). These approvals mark a significant advancement in the treatment of allergic and inflammatory airway diseases in China.
Seasonal Allergic Rhinitis Approval
The NMPA approval for seasonal allergic rhinitis was based on a Phase III clinical trial evaluating the efficacy and safety of Stapokibart in adult patients poorly controlled with nasal corticosteroids or other therapies. The study demonstrated that Stapokibart significantly improved nasal symptoms during the pollen season compared to standard treatment (nasal spray hormones combined with antihistamines). Specifically, the least-squares mean (LSMean) difference between the groups was -1.3, with a 95% confidence interval also of -1.3, indicating a highly statistically significant difference (P = 0.0008). This difference exceeded the minimal clinically important difference (MCID) of 0.23, demonstrating substantial clinical benefits.
In addition to alleviating nasal symptoms such as runny nose, nasal congestion, nasal itching, and sneezing, Stapokibart also effectively reduced ocular allergic symptoms, including eye itching, burning, tearing, and redness. The treatment also improved the overall quality of life for patients with seasonal allergic rhinitis, with a favorable safety profile.
Chronic Rhinosinusitis with Nasal Polyposis Approval
Stapokibart's approval for CRSwNP was supported by a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study. Results showed that Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks compared to placebo (P<0.0001). The treatment also relieved rhinosinusitis symptoms, restored sense of smell, improved nasal symptoms, and enhanced quality of life, with a favorable safety profile.
Mechanism of Action
Stapokibart is a high-efficiency, humanized antibody that targets the interleukin-4 receptor alpha subunit (IL-4Rα). By blocking IL-4Rα, Stapokibart inhibits both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are key cytokines that trigger type II inflammation. Stapokibart is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA.
With these approvals, Stapokibart is now approved for three indications, including moderate-to-severe atopic dermatitis in adults (approved September 2024), chronic rhinosinusitis with nasal polyposis (approved December 2024) and seasonal allergic rhinitis (approved February 2025).
