Zhitong Finance App News, on September 2, Fu Hong Hanlin (02696.HK) and Organon (OGN) jointly announced today that the US Food and Drug Administration (FDA) has approved marketing applications for desumab injection (60 mg/mL) BILDYOS® (denosumab-nxxp) and dexumab injection (120mg/1.7 mL) BILPREVDA® (denosumab-nxxp). The two products are bioanalogs of PROLIA® (denosumab) and XGEVA® (denosumab), respectively. This approval covers all the indications that the original research product has been approved for in the US.

Zhitongcaijing · 09/02/2025 10:41
Zhitong Finance App News, on September 2, Fu Hong Hanlin (02696.HK) and Organon (OGN) jointly announced today that the US Food and Drug Administration (FDA) has approved marketing applications for desumab injection (60 mg/mL) BILDYOS® (denosumab-nxxp) and dexumab injection (120mg/1.7 mL) BILPREVDA® (denosumab-nxxp). The two products are bioanalogs of PROLIA® (denosumab) and XGEVA® (denosumab), respectively. This approval covers all the indications that the original research product has been approved for in the US.