On December 23, Gelonghui reported that KEYMED BIO-B (02162.HK) announced that the National Medical Products Administration of China ("NMPA") has recently approved the market application for the new indication of Supatucel-T (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda, research code: CM310) for the treatment of chronic sinusitis with nasal polyps.

This approval is based on a multicenter, randomized, double-blind, placebo-controlled phase III clinical study, primarily aimed at confirming the efficacy and safety of Supatucel-T injection in patients with chronic sinusitis with nasal polyps. The study results indicated positive data from this phase III clinical trial. Compared to the placebo, Supatucel-T treatment for 24 weeks significantly reduced nasal polyps (Nasal Polyp Score (NPS) improved by 2.3 from baseline) and alleviated nasal congestion (Nasal Congestion Score (NCS) improved by 0.7 from baseline), showing a highly significant statistical difference (P all <0.0001). It also effectively mitigated sinus inflammation, restored the sense of smell, improved nasal-related symptoms, and enhanced quality of life. It also demonstrated good safety.