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地舒单抗注射液60mg(BA6101)
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博安生物:公司两款地舒单抗注射液在英国上市申请获受理
Xin Lang Cai Jing· 2025-11-07 05:26
Core Viewpoint - The company has received acceptance for its marketing authorization applications for two monoclonal antibody injection products in the UK, indicating progress in its product pipeline and potential market expansion [1] Group 1: Product Development - The company has developed BA6101, a 60mg injection for orthopedic applications, and BA1102, a 120mg injection for oncology applications [1] - The acceptance of the marketing authorization applications by the UK Medicines and Healthcare products Regulatory Agency marks a significant milestone for the company's product offerings [1]
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
Xin Lang Cai Jing· 2025-11-07 04:17
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]