HUTCHMED And Innovent Biologics Announce That The Joint New Drug Application For The Combination Of Elunate And Tyvyt Has Been Granted Approval By The China National Medical Products Administration

Companies 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 fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of patients with locally advanced or metastatic renal cell carcinoma. The study met its primary endpoint of progression free survival ("PFS") as assessed by blinded independent central review ("BICR").

"The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Optimizing the selection of treatment for individual patients is a key focus of clinical interest," said Professor Dingwei Ye of Fudan University Shanghai Cancer Center and co-lead Principal Investigator of the FRUSICA-2 study. "The approval of the fruquintinib and sintilimab combination underscores its potential to address the pressing medical needs of patients with this challenging disease."

"The FRUSICA-2 trial results provided compelling evidence that the fruquintinib and sintilimab combination could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma," said Professor Zhisong He of Peking University First Hospital and co-lead Principal Investigator of the FRUSICA-2 study. "We are optimistic about the clinical implications of this approval as we strive to provide effective treatment options for patients."

"This approval reaffirms our deep commitment to delivering innovative therapies to patients facing advanced renal cell carcinoma in China, where second-line treatment options remain limited," said Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. "We are excited to continue pushing the boundaries of our research — across monotherapies, combination strategies, and exciting new platforms such as our ATTC technology — to unlock even greater therapeutic potential across various tumor types, ultimately providing more impactful and transformative solutions to patients."

Dr Hui Zhou, Chief R&D Officer of Oncology of Innovent, stated: "The approval is a significant milestone for patients with advanced renal cell carcinoma in China. It further validates the potential of the sintilimab plus fruquintinib combination regimen, now approved for two difficult-to-treat cancers. We are also proud to achieve the 10th approved indication for sintilimab (TYVYT®), and remain committed to advancing clinical value optimization to benefit an even broader population of cancer patients."