Fosun Pharma subsidiary gains FDA approval for two bone drugs

Shanghai Fosun Pharmaceutical Group announced that its controlled subsidiary, Shanghai Henlius Biotech, has received US FDA approval for two specifications of its Denosumab injection (HLX14) – BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7mL). BILDYOS® is approved for various bone conditions, including osteoporosis in postmenopausal women at high risk of fracture, while BILPREVDA® addresses bone-related events in multiple myeloma and solid tumor patients with bone metastasis.

This approval marks the third product for Henlius Biotech to gain US FDA approval, expanding the group's product line and strengthening its international market presence. As of July 2025, the cumulative R&D investment for HLX14 by Fosun Pharma is approximately RMB 323m.

Globally, the Denosumab injection product recorded sales of approximately $7.462bn in 2024, according to IQVIA MIDAS™ data. Henlius Biotech granted commercialization rights for HLX14 outside mainland China, Hong Kong, Macau, and Taiwan to Organon LLC in June 2022, and will receive sales milestones and royalties under this agreement.