Key Metrics
10.18
Heat Index-
Impact LevelMedium
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Scope LevelNational
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Last Update2025-09-02
Key Impacts
Positive Impacts (5)
Negative Impacts (2)
Event Overview
Cross-border regulatory approvals highlight the increasing global integration of pharmaceutical markets and the entry of Chinese drug manufacturers into established markets. The event underlines shifting dynamics in intellectual property, competitive positioning, and patient access in specialized therapies. It reflects broader themes of international regulatory recognition, the potential for new pathways in drug approval, and heightened scrutiny of global pharmaceutical standards for innovation and safety.
Collect Records
Fosun Hanlin's Denosumab Approved by FDA as First Chinese-Made Version
On September 2, Fosun Hanlin announced that its self-developed and manufactured denosumab injection products (60mg/mL and 120mg/1.7mL) have received approval from the United States FDA for market launch. The products are approved for eight indications, including the treatment of osteoporosis and bone-related events. This marks the first time a domestically produced Chinese denosumab has been approved overseas. Fosun Hanlin now has three products approved in the United States.