INNOVENT BIO (01801) announced that the new drug application for the combination therapy of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has been approved by the National Medical Products Administration (NMPA) of China. The approval covers the treatment of patients with locally advanced or metastatic renal cell carcinoma (RCC) who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapy and have not previously received a programmed death receptor-1 (PD-1) or programmed death ligand-1 (PD-L1) inhibitor in the first-line setting. This approval is supported by data from the FRUSICA-2 study. FRUSICA-2 is a randomized, open-label, active-controlled registration study designed to evaluate the efficacy and safety of the sintilimab and fruquintinib combination therapy versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC. The study has met its primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR). This approval represents a significant milestone for patients with advanced RCC in China. It further validates the potential of the sintilimab and fruquintinib combination therapy, which has now been approved for two difficult-to-treat cancers. The company also takes pride in this being the tenth approved indication for TYVYT® (sintilimab injection) and remains committed to enhancing its clinical value to benefit a broader patient population with cancer.