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PRNewsWire
13 days ago
Innovent and HUTCHMED Jointly Announce NMPA Approval for TYVYT® (Sintilimab Injection) in Combination with ELUNATE® (Fruquintinib) for the Treatment of Patients with Locally Advanced or Metastatic Renal Cell Carcinoma
Reduced risk of disease progression or death by 63%, with median PFS of 22.2 months in the FRUSICA-2 registration study SAN FRANCISCO and SUZHOU, China, May 21, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), today jointly announce that the New Drug Application (NDA) for the combination of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has been granted approval by the China National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKI) therapy and have not received programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy in the first-line setting. The approval is supported by data from FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of sintilimab in combination with fruquintinib versus axitinib or everolimus monotherapy for the second-line treatment of patients with locally advanced or metastatic renal cell carcinoma.