HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Renal Cell Carcinoma

Core Viewpoint - The acceptance of the New Drug Application (NDA) for the combination of fruquintinib and sintilimab for treating advanced renal cell carcinoma in China represents a significant advancement in addressing unmet medical needs in this patient population [1][3]. Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [16]. - Innovent Biologics is a leading biopharmaceutical company dedicated to providing affordable, high-quality biopharmaceuticals, with a focus on innovative medicines for various diseases, including cancer [17]. Product Information - Fruquintinib is a selective oral inhibitor targeting all three vascular endothelial growth factor receptors (VEGFR) and is designed to inhibit tumor angiogenesis effectively [5]. - Sintilimab, marketed as TYVYT, is a PD-1 monoclonal antibody that reactivates T-cells to combat cancer by blocking the PD-1/PD-L1 pathway [11]. Clinical Study Insights - The NDA is supported by data from the FRUSICA-2 study, which demonstrated that the combination of fruquintinib and sintilimab met its primary endpoint of progression-free survival (PFS) and showed improvements in secondary endpoints such as objective response rate (ORR) and duration of response (DoR) [2][3]. - In a proof-of-concept Phase Ib/II study, the combination therapy showed a confirmed ORR of 60.0% and a disease control rate (DCR) of 85.0%, with a median PFS of 15.9 months [10]. Market Context - Kidney cancer poses significant challenges in China, with approximately 74,000 new cases diagnosed in 2022, and renal cell carcinoma accounts for about 90% of kidney tumors [4]. - The combination therapy aims to provide a more effective second-line treatment option for patients who have failed prior treatments with tyrosine kinase inhibitors (TKIs) [3][9]. Regulatory Milestones - The combination of fruquintinib and sintilimab previously received conditional approval for treating advanced mismatch repair proficient (pMMR) endometrial cancer in December 2024, indicating the ongoing regulatory progress for these therapies [3][7].