Marketing Authorization Applications for Boan Biotech’s Two Denosumab Injections Accepted in the UK

Yantai, China, October 7, 2025 – Boan Biotech today announced that the Marketing Authorization Applications (MAAs) for its two denosumab injections, BA6101, a 60 mg denosumab injection for orthopedic indications, and BA1102, a 120 mg denosumab injection for oncology indications, have been accepted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

As a biosimilar of Prolia®, BA6101 was already approved for marketing in China in 2022 under the trade name Boyoubei®. It was the first domestically developed denosumab injection in China.The feedback on the product from physicians and patients has been positive over the past three years since its launch. The company has submitted the MAA for this product in the UK regarding the following indications: 1) Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women BA6101 significantly reduces the risk of vertebral, non-vertebral and hip fractures ; 2) Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, BA6101 significantly reduces the risk of vertebral fractures; and 3) Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. 

BA1102 is a biosimilar of Xgeva®. It was already approved for marketing in China in 2024 under the trade name Boluojia®. Its MAA in the UK covers the following indications: 1) Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone; and 2) 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 . 

BA6101 and BA1102 are core products developed by Boan Biotech under its global R&D strategy. The company is actively conducting clinical trials abroad. In addition to the UK, the company will also submit MAAs for them to the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Driven by broad clinical needs and well-established therapeutic benefits, denosumab has demonstrated substantial market potential worldwide. Publicly available data shows that the combined worldwide sales of Prolia and Xgeva in 2024 were approximately USD 6.6 billion. To support its global commercial goals, Boan Biotech has established a quality management system in line with Chinese, American, European, and Japanese standards, to ensure the quality of denosumab and other subsequent biologics for exporting abroad. 

Dr. Changlin Dou, President of R&D and Chief Operating Officer at Boan Biotech, said: “The MAA submission in the UK represents a major milestone in Boan Biotech’s international expansion and aligns with our ‘In China, for the World’ strategy. We expect that BA6101 and BA1102 will be approved for all the indications granted to the originator drugs in the UK, which will also serve as the first stop for these products in reaching international patients. We will continue to submit MAAs for them in other countries as part of our commitment to providing high-quality, affordable biologics to patients worldwide.”