首個“中國籍”地舒單抗在美獲批上市！復宏漢霖(02696.HK)攜手Organon開拓美國關鍵骨骼護理治療市場

智通財經

09/02

【首個“中國籍”地舒單抗在美獲批上市！復宏漢霖(02696.HK)攜手Organon開拓美國關鍵骨骼護理治療市場】智通財經APP訊，9月2日，復宏漢霖(02696.HK)與Organon(OGN)今日共同宣佈，美國食品藥品監督管理局(FDA)已批准地舒單抗注射液(60mg/mL)BILDYOS®(denosumab-nxxp)和地舒單抗注射液(120mg/1.7mL)BILPREVDA®(denosumab-nxxp)的上市申請。兩款產品分別爲PROLIA®(denosumab)和XGEVA®(denosumab)的生物類似藥，此次獲批覆蓋原研產品在美國已獲批的所有適應症。

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