首个“中国籍”地舒单抗在美获批上市！复宏汉霖(02696.HK)携手Organon开拓美国关键骨骼护理治疗市场

智通财经

2025/09/02

【首个“中国籍”地舒单抗在美获批上市！复宏汉霖(02696.HK)携手Organon开拓美国关键骨骼护理治疗市场】智通财经APP讯，9月2日，复宏汉霖(02696.HK)与Organon(OGN)今日共同宣布，美国食品药品监督管理局(FDA)已批准地舒单抗注射液(60mg/mL)BILDYOS®(denosumab-nxxp)和地舒单抗注射液(120mg/1.7mL)BILPREVDA®(denosumab-nxxp)的上市申请。两款产品分别为PROLIA®(denosumab)和XGEVA®(denosumab)的生物类似药，此次获批复盖原研产品在美国已获批的所有适应症。

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