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复星医药:复宏汉霖两款地舒单抗注射液获美国FDA批准
Xin Lang Cai Jing·2025-09-01 11:11

Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, received FDA approval for its self-developed denosumab injection (HLX14) in two specifications, which includes five indications for osteoporosis treatment [1] Group 1: Product Approval - The FDA approved the biologics license application (BLA) for denosumab injection in two concentrations: 60mg/mL and 120mg/1.7mL [1] - The approved indications include treatment for osteoporosis in postmenopausal women, osteoporosis in male patients, glucocorticoid-induced osteoporosis, non-metastatic prostate cancer in male patients undergoing androgen deprivation therapy, and breast cancer in women receiving aromatase inhibitor therapy [1] Group 2: Market Potential - The global sales revenue for denosumab injection is approximately $7.462 billion [1]