October 27, 2022 -- Luye Pharma Group announced today that BA2101 has been approved by the Center for Drug Evaluation of the National Medical Products Administration for clinical trials in China. This is an anti-IL-4Rα human monoclonal antibody developed by the Group’s subsidiary Boan Biotech, and is recognized as a Class 1 innovative biological product in China. It’s also China’s first long-acting anti-IL-4Rα monoclonal antibody approved for clinical Trials.
BA2101 injection is an innovative, long-acting human monoclonal antibody in IgG4 subtype that targets interleukin-4 receptor subunit α (IL-4Rα). The drug will be administered subcutaneously with an expected dosing interval of 4 weeks. BA2101 injection can inhibit IL-4 and IL-13 signaling simultaneously, regulate Th2 inflammatory pathway, reduce eosinophils and circulating IgE level, and treat allergic diseases caused by type 2 inflammation. It is expected to be used to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and chronic spontaneous urticarial.
The completed preclinical studies show that BA2101 has a longer half-life and higher drug exposure in cynomolgus monkeys than the marketed product with the same target. It is expected that BA2101 may achieve a dosing interval for once every 4 weeks in humans, while drugs with the same target usually adopt a 2-week dosing interval. In the B-hIL4/hIL-4Rα mouse model of asthma, BA2101 showed similar efficacy compared with the marketed drug, and significantly inhibited the enrichment of eosinophils in the lung and the production of OVA-specific IgE in mice. In the B-hIL4/hIL-4Rα mouse model of atopic dermatitis, equal doses of BA2101 and the marketed drug demonstrated comparable inhibitory effects on serum IgE levels, and significantly inhibited ear swelling in mice. The toxicological study showed good safety of BA2101 in B-hIL4/hIL-4Rα mice. BA2101 injection is expected to become an important long-acting drug for the treatment of Th2-type inflammatory diseases in the future.
The drug targeting IL-4Rα has been launched for five indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and eosinophilic esophagitis. In addition to the currently approved indications, clinical trials for the treatment of a variety of diseases caused by Th2 inflammation or other allergies are undergoing, including chronic pruritus of unknown etiology, neurodermatitis, atopic hand-foot dermatitis, chronic spontaneous urticaria, cold urticaria, bullous pemphigoid, allergic fungal rhinosinusitis, chronic sinusitis without nasal polyps, chronic obstructive pulmonary disease, and allergic bronchopulmonary aspergillosis. IL-4Rα is regarded as an important target for the treatment of those diseases, and the anti-IL-4Rα antibody has been one of the best-selling biologics in this field. According to a report of 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, whereas in China, this market is expected to reach RMB 28.2 billion by 2030, growing at a CAGR of 76.8% during the same period.
Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: "Th2 inflammatory diseases such as atopic dermatitis, asthma, prurigo nodularis, chronic sinusitis with nasal polyps, and chronic spontaneous urticaria can pose serious physical, mental and financial burdens to patients. If they cannot receive timely, standard and long-term treatments, their diseases are likely to aggravate or recur, and various inflammatory complications may follow. The long-acting mechanism of BA2101 makes it easier to provide a long-term and standard treatment for Th2 inflammation diseases or other allergic diseases. Given the huge demand in clinical practice, the long-acting BA2101 will be very promising in the marketplace."