Hutchmed And Innovent Secure NMPA Approval For ELUNATE-TYVYT Combo In Advanced Renal Cell Carcinoma

(RTTNews) - HUTCHMED (HCM) and Innovent Biologics, Inc (HKEX:1801) said the China National Medical Products Administration (NMPA) has approved the combination of ELUNATE (fruquintinib) and TYVYT (sintilimab injection) for patients with locally advanced or metastatic renal cell carcinoma (RCC) who have failed prior VEGFR-TKI therapy and have not received PD-1/ PD-L1 inhibitors in the first-line setting. Approval Backed by Strong Phase 3 Data The approval is supported by results from FRUSICA-2, a randomized, open-label, active-controlled Phase 3 registration study comparing fruquintinib plus sintilimab against axitinib or everolimus monotherapy in second-line RCC. The trial met its primary endpoint, showing a 63% reduction in the risk of disease progression or death. Median progression-free survival reached 22.2 months with the combination versus 6.9 months for the control arm. The combination also demonstrated: - Objective response rate: 60.5% vs 24.3%. - Median duration of response: 23.7 months vs 11.3 months - Consistent efficacy across all IMDC prognostic risk groups Safety findings were consistent with the known profiles of each drug, with no new safety signals identified. Clinical Significance Investigators noted that the approval highlights the growing importance of targeted and immunotherapy combinations in advanced RCC. The regimen offers a new option for patients who have limited second-line treatments in China. Innovent emphasized that this marks the 10th approved indication for TYVYT in China, reinforcing its role as a widely used PD-1 inhibitor in the country's oncology landscape. About the Drugs Fruquintinib is a selective oral inhibitor of VEGFR-1, -2, and -3 designed to block tumor angiogenesis with high specificity and minimal off-target activity. It is co-developed in China by Hutchmed and Eli Lilly and marketed as ELUNATE for metastatic colorectal cancer, with global rights licensed to Takeda under the brand FRUZAQLA outside China. Sintilimab (TYVYT) is a PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly. It works by blocking the PD-1/PD-L1 pathway to reactivate T-cells to kill cancer cells. HCM has traded between $11.81 and $19.50 over the past year. The stock closed Wednesday's trading at $11.91, down 1.24%. In pre-market trading the stock is at $11.95, up 0.34%. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.