Innovent Bio (01801) announced that China’s National Medical Products Administration (NMPA) has approved the combination of TYVYT (sintilimab injection) and ELUNATE (fruquintinib) for patients with locally advanced or metastatic renal cell carcinoma (RCC) who have progressed after VEGFR-TKI therapy and have not previously received PD-1/PD-L1 inhibitors in the first-line setting. The decision marks the 10th approved indication for Innovent’s PD-1 therapy sintilimab and represents the second Chinese approval for the sintilimab-fruquintinib regimen across different tumor types.

Key clinical evidence comes from the randomized, open-label Phase III FRUSICA-2 study (NCT05522231). With a median follow-up of 16.6 months (data cutoff 17 Feb 2025), the combination achieved: • Median PFS of 22.2 months versus 6.9 months for axitinib or everolimus monotherapy (stratified HR 0.373; p < 0.0001). • Objective response rate of 60.5% versus 24.3% (Odds Ratio 4.622; p < 0.0001). • Median duration of response of 23.7 months versus 11.3 months. • Overall survival data remain immature at ~20% maturity. Efficacy benefits were consistent across all International mRCC Database Consortium (IMDC) prognostic risk groups, and safety findings aligned with the known profiles of each agent.

Renal cell carcinoma accounts for roughly 90% of kidney cancers. In 2022, China recorded an estimated 74,000 new kidney cancer cases out of 435,000 worldwide.

TYVYT is co-developed by Innovent and Eli Lilly; ELUNATE is co-developed by HUTCHMED and Eli Lilly and marketed ex-China by Takeda under the brand name FRUZAQLA. The newly approved RCC indication adds to the regimen’s existing conditional approval in mismatch repair-proficient endometrial cancer in China.

Innovent’s management highlighted the approval as a significant milestone in expanding sintilimab’s clinical utility and reinforcing its position as a cornerstone PD-1 therapy in China’s oncology landscape.