RegulatoryMay 21, 2026, 06:32 AM
HUTCHMED & Innovent Get NMPA Approval for ELUNATE®; 63% Reduced Risk
AI Summary
HUTCHMED (China) Limited and Innovent Biologics, Inc. jointly announced that the China National Medical Products Administration (NMPA) has approved their combination therapy of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection). This approval is for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior VEGFR-TKI therapy. The decision is supported by data from the FRUSICA-2 study, which demonstrated a 63% reduction in the risk of disease progression or death, with a median progression-free survival of 22.2 months.
Key Highlights
- NMPA approved ELUNATE® (fruquintinib) + TYVYT® (sintilimab) for advanced renal cell carcinoma.
- Approval for patients who failed prior VEGFR-TKI therapy and not received PD-1/PD-L1 inhibitors.
- FRUSICA-2 study showed 63% reduced risk of disease progression or death.
- Median progression-free survival (PFS) was 22.2 months vs 6.9 months.
- Objective response rate (ORR) was 60.5% vs 24.3%.
- Median duration of response (DoR) was 23.7 months vs 11.3 months.
- This marks the 10th approved indication for sintilimab (TYVYT®).
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