Core Viewpoint - The company, Boan Biotech (06955), has seen its stock rise over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities in the orthopedic and oncology sectors [1] Group 1: Product Development - Boan Biotech announced that its self-developed monoclonal antibody injections, BA6101 (60mg) for orthopedics and BA1102 (120mg) for oncology, have received acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorization [1] - The company considers BA6101 and BA1102 as core products in its global development strategy and plans to submit applications to other international regulatory bodies, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan [1] Group 2: Market Potential - There is a broad market outlook for the monoclonal antibody, denosumab, due to extensive clinical demand and significant clinical value, with global sales for Prolia and Xgeva projected to reach approximately $6.6 billion in 2024 [1] - To support its global commercialization goals, the company has established a comprehensive quality management system that meets international standards in China, Europe, the United States, and Japan, ensuring quality assurance for denosumab and future biopharmaceuticals [1]
港股异动 | 博安生物(06955)午后涨超4% 两款地舒单抗注射液上市申请获英国MHRA受理