Hutchmed (HCM) and Innovent Biologics have received approval from China's National Medical Products Administration for the combination of TYVYT and Elunate for certain patients with locally advanced or metastatic renal cell carcinoma, the companies said Thursday.

The approval covers patients whose disease progressed after prior VEGFR-TKI therapy and who had not previously received PD-1 or PD-L1 inhibitor treatment in the first-line setting.

The approval was supported by results from the FRUSICA-2 registration study, in which the combination reduced the risk of disease progression or death by 63% and achieved median progression-free survival of 22.2 months, compared with axitinib or everolimus monotherapy, the companies said.