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复宏汉霖(02696.HK):欧盟委员会批准HLX14产品用于特定人群骨质疏松症治疗等适应症

Core Insights - The company, Fuhong Hanlin (复宏汉霖), has received approval from the European Commission for the marketing authorization applications (MAAs) of two products, BILDYOS and BILPREVDA, which are now authorized for sale in all EU member states and EEA countries [1][2] - 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 bone-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] Product Details - BILDYOS (60mg/mL) is approved for three specific indications: 1. Treatment of osteoporosis in high-risk postmenopausal women and men 2. Treatment of bone loss in high-risk prostate cancer men related to hormone ablation 3. Treatment of bone loss in high-risk adult patients associated with long-term systemic glucocorticoid therapy [1] - BILPREVDA (120mg/1.7mL) is approved for two specific indications: 1. Prevention of bone-related events in adults with advanced bone malignancies 2. Treatment of giant cell tumors of bone in adults and skeletally mature adolescents [1] Market Context - The company’s biosimilar HLX14, a denosumab product, has also received approval in the U.S. for specific osteoporosis indications, covering all indications of the original product [2] - The global sales of denosumab are projected to be approximately $7.463 billion in 2024, indicating a significant market opportunity for the company’s products [2] - The approval of BILDYOS and BILPREVDA in the EU represents a further step in the company's international expansion and enhances the global influence of its product portfolio [2]