Core Viewpoint - Innovent Biologics and HUTCHMED announced the acceptance of a New Drug Application (NDA) for the combination of sintilimab and fruquintinib for treating locally advanced or metastatic renal cell carcinoma (RCC) patients who have failed prior treatment with one tyrosine kinase inhibitor (TKI) [1][2][3] Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing high-quality medicines for major diseases, including oncology, and has launched 15 products in the market [14] - HUTCHMED is committed to discovering and commercializing targeted therapies and immunotherapies for cancer and immunological diseases, with its first three medicines marketed in China [17] Product Details - Sintilimab, marketed as TYVYT®, is a PD-1 inhibitor that has received approval for multiple indications in China, including its recent NDA for advanced RCC [5][6] - Fruquintinib is a selective oral inhibitor of VEGFRs, co-developed by HUTCHMED and Eli Lilly, and is approved for treating metastatic colorectal cancer in China [7][9] Clinical Study Insights - The NDA is supported by data from the FRUSICA-2 study, which demonstrated significant improvements in progression-free survival (PFS), objective response rate (ORR), and duration of response (DoR) for the combination therapy [2][3] - The FRUSICA-2 study met its primary endpoint, and the safety profile of the combination was found to be tolerable with no new safety signals [2][3] Market Context - In 2022, approximately 435,000 new kidney cancer cases were diagnosed globally, with around 74,000 cases in China, indicating a significant unmet medical need for effective treatments [4] - The combination therapy aims to address the challenges faced by RCC patients who have limited treatment options after failing first-line therapies [3][12]

Core Insights - The FRUSICA-2 Phase 2/3 clinical trial has successfully met its primary endpoint of progression-free survival (PFS) for the combination of sintilimab and fruquintinib in treating advanced renal cell carcinoma (RCC) in China [1][3] - The combination therapy has received conditional approval from China's National Medical Products Administration (NMPA) for advanced endometrial cancer, indicating its potential in multiple cancer types [2][11] - The study demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR), with full results expected to be presented at a scientific conference [3] Company Overview - Innovent Biologics, Inc. is a biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [1][18] - HUTCHMED (China) Limited is committed to the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [21][22] - Both companies are collaborating to advance the registrational communication of the sintilimab and fruquintinib combination therapy [4][5] Clinical Trial Details - The FRUSICA-2 study is a randomized, open-label trial comparing sintilimab and fruquintinib against axitinib or everolimus monotherapy for second-line treatment of advanced RCC [3][16] - The trial's positive results are seen as a significant advancement in treatment options for patients who have not responded adequately to previous therapies [4][5] Market Context - In 2022, approximately 435,000 new kidney cancer cases were diagnosed globally, with 74,000 in China, highlighting the substantial market potential for effective treatments [5] - The combination of sintilimab and fruquintinib addresses an unmet medical need for advanced RCC patients who have previously failed single-agent targeted therapies [16][17]