YANTAI, China, Feb. 16, 2023 /PRNewswire/ -- Luye Pharma Group today announced that BA2101, an investigational anti-IL-4Rα antibody developed by its subsidiary Boan Biotech, has been administered for the first patient in a Phase I clinical trial. Recognized as a Class 1 innovative biological product in China, BA2101 is the first long-acting anti-IL-4Rα monoclonal antibody that enters the clinical trial stage in the country. It is intended to be used for treating allergic diseases caused by Th2 inflammation, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and chronic spontaneous urticaria (CSU).

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 Th2 inflammatory pathway, and reduce eosinophils and circulating IgE levels. It is designed to be administered subcutaneously with an expected dosing interval of 4 weeks.

Th2 inflammatory diseases are common chronic diseases with a large number of patients, and many patients often suffer from comorbidities with a protracted course. If not treated in a timely and long-term manner with standard therapies, their condition may become worse or a relapse may occur, followed by various Th2 inflammatory complications, causing serious physical and mental burdens to them.

IL-4Rα is a key target for the treatment of Th2 inflammatory diseases, and the long-acting mechanism of BA2101 makes it easier to provide a long-term and standard treatment for such diseases. 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. BA2101 may be administered once every 4 weeks in humans, while drugs with the same target usually adopt a 2-week dosing interval. BA2101 is more convenient for clinical use, providing important clinical value in the long-term management of Th2 inflammatory diseases.

The marketed drug targeting IL-4Rα has been approved for five indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and eosinophilic esophagitis. Furthermore, clinical trials for a variety of additional indications caused by Th2 inflammation or other allergies are underway, including chronic pruritus of unknown origin, atopic hand and foot dermatitis, CSU, cold urticaria, bullous pemphigoid, allergic fungal rhinosinusitis, chronic sinusitis without nasal polyps, chronic obstructive pulmonary disease, and allergic bronchopulmonary aspergillosis.

Due to the huge unmet treatment needs for the diseases mentioned above, with its long dosing interval, BA2101 is expected to have a promising future in the marketplace. 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, 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.

"Th2 inflammatory diseases involve multiple pathologies and frequent comorbidities, imposing heavy burdens to patients. With its unique long-acting and targeting mechanism, BA2101 as a new treatment option will help to improve the quality of life for patients," said Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech. "At Boan Biotech, we are committed to building a differentiated product portfolio following a patient-centric and value-driven strategy. We already have a pipeline that includes several proprietary innovative antibodies. We will speed up their development to address the unmet needs for the benefit of patients."

About Boan Biotech

As a subsidiary of Luye Pharma Group, Boan Biotech is a fully-integrated biopharmaceutical company that specializes in developing, manufacturing and commercializing therapeutic antibodies, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic diseases. The company's antibody discovery is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform and ADC Technology Platform. Boan Biotech's product portfolio currently includes two commercialized products, multiple investigational antibodies protected by international intellectual property rights, and a number of biosimilar candidates.

Boan Biotech operates across the entire value chain of the industry from antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, and technology transfer to pilot and commercial production. In addition to China, the company also conducts biopharmaceutical product development in the U.S. and the EU.

Source: Luye Pharma Group