Shandong Boan Biotechnology Co., Ltd. (the “Company,” Stock Code: 6955) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted its Marketing Authorisation Applications (MAAs) for two denosumab injections. The 60 mg formulation (BA6101), already approved in the People’s Republic of China under the trade name Boyoubei® in 2022, is intended for orthopedic-related uses. The proposed UK indications focus on treating osteoporosis in postmenopausal women and men at increased fracture risk, as well as addressing bone loss associated with hormone ablation or long-term systemic glucocorticoid therapy.

The second injection, BA1102, a 120 mg formulation for oncology indications, was approved in China in 2024 under the trade name Boluojia®. In the UK, the MAA for BA1102 covers the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of giant cell tumor of bone that is unresectable or where surgery would lead to severe morbidity.

These two products align with the Company’s global research and development strategy. Further applications to the European Medicines Agency, the U.S. Food and Drug Administration, and Japan’s Pharmaceuticals and Medical Devices Agency are planned. Public data indicates that global sales of Prolia® and Xgeva®—the reference products—reached approximately USD 6.6 billion in 2024, underscoring the market potential of denosumab worldwide. The Company has developed a quality management system compliant with Chinese, U.S., European, and Japanese standards to ensure consistent product quality abroad.

The announcement was made in Yantai, the People’s Republic of China, on 7 November 2025.