Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international presence and product influence in the market [1][2] Group 1: Product Approval - BILDYOS and BILPREVDA have received centralized marketing authorization in all EU member states and EEA countries, which includes Iceland, Liechtenstein, and Norway [1] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for bone loss related to prostate cancer and long-term systemic glucocorticoid therapy [1] - BILPREVDA is indicated for the prevention of skeletal-related events in adults with advanced bone malignancies and for the treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Group 2: Regulatory and Clinical Background - The approval was based on a comprehensive review of comparative studies demonstrating the high similarity of HLX14 (the active ingredient in BILDYOS and BILPREVDA) to its reference drug, Prolia, in terms of quality, safety, and efficacy [2] - The company received two GMP certificates from the Belgian Federal Agency for Medicines and Health Products in June 2025, confirming compliance with EU GMP standards for the production line of HLX14 [2] - In July 2025, HLX14 received a positive opinion from the EMA's Committee for Medicinal Products for Human Use, recommending the approval of the marketing authorization applications for BILDYOS and BILPREVDA [2]
复宏汉霖：欧盟委员会批准 HLX14(地舒单抗)两个产品用于特定人群骨质疏松症治疗等适应症