BOAN BIOTECH (06955): Two types of Dexu Monoclonal Antibody Injections have been accepted for market approval in the United Kingdom.

Boan Biotech (06955) announced that the UK marketing authorization applications for their independently developed orthopedic drug Denosumab Injection 60mg (BA6101) and oncology drug Denosumab Injection 120mg (BA1102) have been accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). BA6101 is a biosimilar of Prolia, the first domestically produced Denosumab injection approved for market in China in 2022 under the name Boyoubi, which has received positive feedback from doctors and patients in clinical use over the past 3 years. The indications for which BA6101 is intended to apply in the UK include: 1. Treatment of osteoporosis in postmenopausal women and men at high risk of fractures. For postmenopausal women, this drug can significantly reduce the risk of vertebral, non-vertebral, and hip fractures; 2. Treatment of bone loss caused by hormone therapy in prostate cancer patients (at high risk of fractures). For men with prostate cancer receiving hormone therapy, this drug can significantly reduce the risk of vertebral fractures; 3. Treatment of bone loss caused by long-term systemic corticosteroid therapy in adult patients (at high risk of fractures). BA1102 is a biosimilar of Xgeva, which was approved for market in China in 2024 under the name Boluojia. The indications for which BA1102 is intended to apply in the UK include: 1. Prevention of bone-related events (pathologic fractures, bone radiation therapy, spinal cord compression or bone surgery) in adults with advanced malignant tumors affecting the bones; 2. Treatment of giant cell tumors of the bone that cannot be surgically removed or may cause severe functional impairment after surgical removal, including adults and skeletally mature adolescents. BA6101 and BA1102 are core products developed by the company based on a global development strategy, and the company is actively promoting the international clinical trials and registration of these two products. In addition to the UK, the company will also submit marketing applications for these two products to international drug regulatory authorities such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Pharmaceutical and Medical Devices Agency of Japan (PMDA). Based on widespread clinical demand and good clinical value among other factors, Denosumab presents a broad market outlook worldwide. Public data shows that the global sales of Prolia and Xgeva totaled approximately $6.6 billion in 2024. To support their global commercialization goals, the company has established a quality management system that complies with relevant standards in China, Europe, the US, Japan, and other countries, ensuring quality assurance for the successful international market entry of Denosumab and more biopharmaceuticals in the future.