Boan Biotech announced that it has signed a licensing agreement for commercializing its self-developed Denosumab Injection (BA6101 and BA1102) in the Brazilian market with a strategic partner.
Under the agreement, this partner will as the MAH commercialize these two products in the Brazilian market, while Boan Biotech will be responsible for the commercial production. Boan Biotech will also receive an upfront payment, milestone payments, and sales royalties.
BA6101 and BA1102 are biosimilars to Denosumab Injection reference drugs Prolia® and Xgeva® respectively. Prolia is widely used for treating osteoporosis around the world, whereas Xgeva is used globally for the treatment of diseases such as multiple myeloma and bone metastasis of solid tumors, giant cell tumors of bone, and hypercalcemia.
In November 2022, BA6101 (trade name: Boyoubei® in Chinese) was launched in China, to become China's first locally developed Denosumab Injection. It received positive feedback from doctors and patients on its clinical application. In May 2024, BA1102 (trade name: Boluojia® in Chinese) was also approved for marketing in China. In addition, BA6101 and BA1102 are developing based on a global development strategy. An international multicenter Phase 3 clinical trial is going on in Europe, the U.S. and Japan, and all subjects have been enrolled at the beginning of 2024. After the completion of this study, Boan Biotech will submit marketing authorization applications for these two drugs to the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and other international regulatory agencies respectively for all approved indications of reference products.
The Brazilian pharmaceutical market is a major emerging market with significant growth potential. IQVIA data indicates that the retail pharmaceutical market in Brazil was valued at approximately USD 31.7 billion in 2023, constituting about half of the entire pharmaceutical market in Latin America. It is expected to maintain an annual growth rate of 9.2% from 2023 to 2028.
Prolia, the reference product for Denosumab Injection, has been approved in Brazil for the treatment of bone loss in postmenopausal osteoporosis, prostate cancer or breast cancer patients undergoing hormone ablation; osteoporosis in men and glucocorticoid-induced osteoporosis. Xgeva has been approved in Brazil for the prevention of bone-related events in patients with multiple myeloma and bone metastases from tumors, for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy, and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
With this strategic cooperation in Brazil, Boan Biotech and its partner will jointly promote the local registration and commercialization of BA6101 and BA1102.
Previously, Boan Biotech has submitted a marketing authorization application for Bevacizumab Injection (trade name: Boyounuo® in Chinese) in Brazil and received GMP certification from the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA).
A number of Boan Biotech's products entering the Brazilian market will provide more treatment options for local patients. The company has established a quality management system in line with Chinese, American, European and Japanese standards, to ensure more high quality products going global.
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