HUTCHMED (China) Limited and Innovent Biologics, Inc. have received National Medical Products Administration approval for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) to treat patients with locally advanced or metastatic renal cell carcinoma (RCC) who have failed prior VEGFR-TKI therapy and have not been exposed to PD-1/PD-L1 inhibitors in the first-line setting.

The authorization is underpinned by the Phase III FRUSICA-2 study (NCT05522231), which compared fruquintinib + sintilimab with axitinib or everolimus monotherapy in the second-line RCC population. Key data at the February 17 2025 cut-off are:

• Median progression-free survival of 22.2 months versus 6.9 months for the control arm, yielding a stratified hazard ratio of 0.373 (p<0.0001), equating to a 63 % reduction in the risk of disease progression or death.

• Objective response rate of 60.5 % compared with 24.3 % for axitinib/everolimus (Odds Ratio 4.622; p<0.0001).

• Median duration of response of 23.7 months versus 11.3 months.

Overall survival analysis remains immature at ~20 % data maturity. Safety findings were consistent with previously reported profiles of each monotherapy.

Strategic implications • The approval provides HUTCHMED’s fruquintinib with a second China-marketed combination indication after colorectal and endometrial cancer settings, reinforcing the asset’s versatility across tumor types.

• For Innovent, sintilimab now holds 10 approved indications in China, expanding the PD-1 inhibitor’s commercial reach in an area where second-line options remain limited.

Market context China recorded an estimated 74,000 new kidney cancer cases in 2022, with renal cell carcinoma accounting for roughly 90 % of diagnoses. Treatment advances are increasingly driven by targeted and immuno-oncology combinations, and the fruquintinib + sintilimab regimen is positioned to address this unmet need.

Corporate outlook HUTCHMED indicated plans to continue exploring combination strategies and next-generation platforms, while Innovent reiterated its commitment to broadening sintilimab’s clinical utility. No financial terms or sales projections were disclosed in the announcement.