Yantai, January 26, 2024/PRNewswire/ -- Boan Biotech announced a partnership with Health Source Pharmaceutical Group Co., Ltd. (Health Yuan) on the exclusive rights of anti-IL-4Rα long-term monoclonal antibody BA2101 injections in mainland China to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD).
According to the cooperation agreement, Health Yuan is authorized to exclusively develop, register, produce and commercialize BA2101 injections in mainland China for the treatment of respiratory diseases such as asthma and COPD. Boan Biotech, on the other hand, continues to hold all rights relating to the product's indications other than the field of respiratory diseases in mainland China, as well as all rights for all indications of the product outside of mainland China.
Health Yuan will pay the down payment to Boan Biotech after signing the agreement, and pay development milestone payments based on the product's development progress. Health Yuan also agreed to pay Boan Biotech potential sales milestone payments and sales commissions based on the net sales of the product in the agreed region. In addition, Health Yuan will be responsible for follow-up clinical trials and development activities for all indications of BA2101 in the field of respiratory diseases in mainland China, and bear related expenses.
BA2101 injection was independently developed by Boan Biotech. It is an innovative long-acting all-human monoclonal IgG4 antibody targeting interleukin-4 receptor subunit α (IL-4Rα). It can simultaneously inhibit IL-4 and IL-13 signaling pathways, regulate Th2 inflammation, and reduce eosinophil content and IgE levels. This product is intended to treat allergic diseases caused by Th2 inflammation, and has now been approved for clinical trials for atopic dermatitis, asthma, COPD, chronic sinusitis with nasal polyps, pruritus nodular, and chronic spontaneous urticaria.
Currently, antibody drugs targeting IL-4Rα usually use a dosage frequency of once every 2 weeks, and BA2101 injections have a long-term mechanism. Preclinical study results showed that BA2101 injection showed a longer half-life in crab-eating monkeys compared to commercially available drugs with the same target, and it is expected that the dosage frequency of once every 4 weeks can be achieved in humans. Completed phase I clinical data show that BA2101 injection has a longer half-life and a slower drug clearance rate, and phase II clinical trials have now been initiated.
Th2 inflammation is an immunopathological mechanism of various diseases involving multiple systems such as skin, breathing, and digestion[i]. Partner Health Yuan is a leading local enterprise in the field of respiratory treatment. It lays out key varieties and forms a rich product portfolio around respiratory medication, and has a complete respiratory marketing team throughout the country, and is in a leading position in this field of treatment.
Referring to this collaboration, Yu Xiong, President of Health Yuan, said, “Asthma and COPD are among the most common chronic respiratory diseases and seriously threaten public health. Clinically, there is an urgent need for innovative drugs to further improve symptoms and levels of control. We are very happy to cooperate with Boan Biotech to obtain exclusive rights for BA2101 injections in mainland China to treat asthma and COPD indications. This product will not only provide new treatment options for patients suffering from diseases, but will also further expand our innovative drug product portfolio in the field of respiratory diseases to better serve patients' unmet treatment needs.”
Dr. Dou Changlin, President and Chief Operating Officer of Boan Biotech Research and Development, said, “Th2 inflammatory diseases involve multiple diseases, and comorbidities are common, putting a heavy burden on patients. IL-4Rα is an important target for the treatment of TH2 inflammatory diseases, and the unique long-term effects of BA2101 will play an important clinical value in the long-term management of related diseases. Through this cooperation, Boan Biotech and Health Yuan will actively use their respective advantages in R&D and commercialization to accelerate the clinical development process of BA2101 injections in diseases such as asthma and COPD. Furthermore, Boan Biotech will also accelerate the development of more indications with efficient clinical development and promotion capabilities, so that patients can benefit as soon as possible.”
Based on the urgent treatment needs in the field of Th2 inflammatory diseases, the long-term characteristics of ba2101 injections are expected to have better treatment compliance and convenience in the field of Th2 inflammatory diseases, higher clinical value, and broad market prospects. According to the Frost & Sullivan report, the global market size of IL-4Rα targeted therapies is expected to reach US$28.7 billion in 2030, with a compound annual growth rate of 21.6% from 2020 to 2030; the market size of IL-4Rα targeted therapies in China is expected to reach RMB 28.2 billion in 2030, with a compound annual growth rate of 76.8% from 2020 to 2030.