China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its Category 1 product BA2101. This marks it as the first long-acting anti-IL-4Rα monoclonal antibody to enter the clinical trial stage in China. BA2101 is being developed to treat allergic diseases caused by Th2 inflammation, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and chronic spontaneous urticaria (CSU).
BA2101: Mechanism of Action
BA2101 is an innovative, long-acting human monoclonal antibody of the IgG4 subtype that targets interleukin-4 receptor subunit α (IL-4Rα). The drug can inhibit IL-4 and IL-13 signaling simultaneously, regulate the Th2 inflammatory pathway, and reduce eosinophils and circulating IgE levels. It is designed to be administered subcutaneously with an expected dosing interval of four weeks.
Market Potential and Precedent
Sanofi’s IL-4Rα-targeted Dupixent (dupilumab) has been approved for five indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and eosinophilic esophagitis. According to statistics from Frost & Sullivan, the size of the global market for IL-4R-targeting therapies is expected to reach USD 28.7 billion by 2030, growing at a CAGR of 21.6% from 2020 to 2030. In China, this market is expected to reach RMB 28.2 billion (USD 4.1 billion) by 2030, growing at a CAGR of 76.8% during the same period. This significant market growth potential underscores the importance of BA2101’s development and its potential to address a large unmet need in the treatment of allergic diseases.-Fineline Info & Tech
