HUTCHMED (China) Ltd (HCM) Form 6-K — May 21, 2026
HUTCHMED and partner Innovent Biologics announced that China’s NMPA has approved the combination of ELUNATE (fruquintinib) and TYVYT (sintilimab) for treating locally advanced or metastatic renal cell carcinoma in patients who have failed prior VEGFR-TKI therapy. The approval is based on the FRUSICA-2 Phase III trial, which showed a 63% reduction in the risk of disease progression or death, with a median progression-free survival of 22.2 months versus 6.9 months for the control arm. This marks the 10th approved indication for sintilimab and expands the commercial potential of fruquintinib in China, where second-line treatment options for renal cell carcinoma remain limited.
Key figures
- Hazard ratio
- 0.373
- Median pfs months
- 22.2
- Control dor months
- 11.3
- Control pfs months
- 6.9
- Control orr percent
- 24.3
- Os maturity percent
- 20
- Risk reduction percent
- 63
- Median follow up months
- 16.6
- Objective response rate percent
- 60.5
- Median duration of response months
- 23.7
- China kidney cancer new patients 2022
- 74000
- Global kidney cancer new patients 2022
- 435000
AI analysis
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