Keymed Biosciences has secured approval from China’s National Medical Products Administration (NMPA) for its anti-IL-4Rα monoclonal antibody drug, Stapokibart (trade name: Kangyueda, 康悦达), for the treatment of seasonal allergic rhinitis.
The approval follows a phase III clinical trial that demonstrated the drug’s effectiveness in patients whose symptoms were not adequately controlled by standard treatments such as nasal corticosteroids and antihistamines. The randomized, double-blind, placebo-controlled study found that a two-week course of Stapokibart significantly reduced nasal allergy symptoms, including runny nose, congestion, itching, and sneezing, compared to conventional therapies. The study showed a statistically significant improvement (P = 0.0008), far exceeding the minimum clinically important difference (MCID), reinforcing its strong clinical benefit.
Beyond nasal relief, Stapokibart was also shown to reduce ocular symptoms such as itchy, watery, and red eyes, further improving patients’ overall quality of life. The drug demonstrated a strong safety profile, making it a promising alternative for those struggling with seasonal allergies.
A First for China’s IL-4Rα Antibody Market
Stapokibart is the first domestically manufactured IL-4Rα monoclonal antibody to receive NMPA approval. By blocking IL-4 and IL-13 signaling—two key drivers of type II inflammation—the drug effectively targets the underlying cause of allergic reactions rather than just alleviating symptoms.
Keymed has already secured approvals for Stapokibart’s use in treating moderate-to-severe atopic dermatitis (September 2024) and chronic rhinosinusitis with nasal polyps (December 2024). With its latest approval, Keymed is positioning itself as a major player in China’s biologics market, offering innovative therapies for inflammatory conditions.
Founded by experts in medical research and commercialization, Keymed Biosciences continues to focus on high-quality, affordable, and innovative treatments for patients in China and beyond.
