Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for its subsidiaries' biosimilar products BILDYOSR and BILPREVDAR, which are based on denosumab [2][3] - The approval allows these products to be marketed in all EU member states as well as Iceland, Liechtenstein, and Norway [2] Product Information - HLX14, the biosimilar denosumab, is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications aligned with the reference products Prolia and XGEVA [2] - The cumulative R&D investment for HLX14 is approximately RMB 323 million as of July 2025 [4] Market Impact - The approval in the EU follows a previous approval in the US, enhancing the company's international market presence [5] - The global sales of denosumab injection products are projected to be approximately USD 7.463 billion in 2024 [4] - Commercial rights for HLX14 outside of China were granted to Organon LLC in June 2022, allowing for milestone and sales commission rights following the EU approval [5]