BOAN BIOTECH (06955) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorization applications for two self-developed denosumab injections: BA6101 (60mg) for orthopedics and BA1102 (120mg) for oncology.

BA6101 is a biosimilar to Prolia® (Chinese brand name: 普罗力®) and became the first domestically produced denosumab injection approved in China in 2022 (Chinese brand name: 博优倍®). Over nearly three years of clinical use, it has received positive feedback from doctors and patients. The proposed indications for BA6101 in the UK include: 1. Treatment of osteoporosis in postmenopausal women and men at high risk of fractures. For postmenopausal women, it significantly reduces the risk of vertebral, non-vertebral, and hip fractures. 2. Treatment of bone loss in prostate cancer patients (at high fracture risk) due to hormonal therapy. For men undergoing hormonal treatment, it significantly lowers vertebral fracture risk. 3. Treatment of bone loss in adults (at high fracture risk) receiving long-term systemic glucocorticoid therapy.

BA1102 is a biosimilar to Xgeva® (Chinese brand name: 安加维®) and was approved in China in 2024 (Chinese brand name: 博洛加®). Its proposed UK indications include: 1. Prevention of skeletal-related events (pathological fractures, bone radiotherapy, spinal compression, or bone surgery) in adults with advanced malignancies involving bone. 2. Treatment of giant cell tumor of bone in patients (adults and skeletally mature adolescents) where surgical resection is unfeasible or may cause severe dysfunction.

BA6101 and BA1102 are core products under BOAN BIOTECH’s global development strategy. The company is actively advancing international clinical and regulatory efforts for both, with plans to submit marketing applications to the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), among other regulators.

Given broad clinical demand and strong therapeutic value, denosumab holds significant global market potential. Public data shows combined 2024 global sales of Prolia® and Xgeva® reached approximately $6.6 billion. To support global commercialization, BOAN BIOTECH has established a comprehensive quality management system compliant with Chinese, U.S., EU, and Japanese standards, ensuring product quality for denosumab and future biologics in international markets.