Core Viewpoint - The company has received acceptance for its marketing authorization applications for BA6101 and BA1102 in the UK, indicating a significant step in its global expansion strategy in the biopharmaceutical sector [1][2] Group 1: Product Information - BA6101 is a biosimilar to Prolia, approved in China in 2022, targeting osteoporosis treatment in postmenopausal women and men at high risk of fractures, as well as bone loss in prostate cancer patients undergoing hormone therapy [1] - BA1102 is a biosimilar to Xgeva, approved in China in 2024, aimed at preventing bone-related events in adults with advanced malignancies and treating patients with giant cell tumors of bone [2] Group 2: Market Potential - The global market for denosumab, represented by Prolia and Xgeva, is projected to reach approximately $6.6 billion in sales by 2024, highlighting the substantial commercial opportunity for the company's products [2] - The company is actively pursuing international clinical trials and regulatory submissions for BA6101 and BA1102 in various regions, including the EMA, FDA, and PMDA, to support its global commercialization goals [2] Group 3: Quality Assurance - The company has established a comprehensive quality management system that meets international standards to ensure the successful international launch of denosumab and future biopharmaceuticals [2]
博安生物：两款地舒单抗注射液在英国的上市申请获受理