Core Insights - The company has received acceptance for its marketing authorization applications for BA6101 and BA1102 in the UK, targeting the orthopedic and oncology fields respectively [1][2] Group 1: Product Details - BA6101 is a biosimilar to Prolia® and was approved in China in 2022, receiving positive feedback from doctors and patients during its clinical application [1] - BA1102 is a biosimilar to Xgeva® and is set to be approved in China in 2024 [2] Group 2: Indications and Applications - BA6101 aims to treat osteoporosis in postmenopausal women and high-risk men, significantly reducing the risk of vertebral, non-vertebral, and hip fractures [1] - BA1102 is intended for preventing skeletal-related events in adults with advanced malignancies and treating patients with giant cell tumors of bone [2] Group 3: Global Strategy and Market Potential - The company is pursuing international clinical and registration efforts for both products, planning submissions to EMA, FDA, and PMDA [2] - The global market for denosumab is promising, with projected combined sales of Prolia® and Xgeva® reaching approximately $6.6 billion in 2024 [2] - The company has established a quality management system compliant with international standards to support the global commercialization of denosumab and future biopharmaceuticals [2]
博安生物(06955.HK)两款地舒单抗注射液在英国的上市申请获受理