By Fineline Cube 
Chinese companies Innovent Biologics, Inc. (HKG: 1801) and HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that the New Drug Application (NDA) for the combination of Tyvyt (sintilimab) and Elunate (fruquintinib) has been accepted by China’s National Medical Products Administration (NMPA). The therapy targets patients with locally advanced or metastatic renal cell carcinoma (RCC) who have previously failed tyrosine kinase inhibitor (TKI) therapy.
Clinical Trial Basis
The NDA filing is based on results from the FRUSICA-2 study. The study demonstrated that the combination therapy met the primary endpoint of progression-free survival (PFS) compared to axitinib or everolimus alone. Secondary endpoints also showed improvements in objective response rate (ORR) and duration of response (DoR). The safety profile of the combination was manageable, with no new safety signals observed.
Previous Approval
In December 2024, the sintilimab/fruquintinib combination was approved for the treatment of advanced endometrial cancer.-Fineline Info & Tech