In the FRUSICA-2 registration study, the risk of disease progression or death was reduced by 63%, with a median progression-free survival of 22.2 months.
ShanghaiMay 21, 2026 /PRNewswire/ — Today, the combination therapy of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) was approved by China’s National Medical Products Administration for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapy and have not received first-line programmed death-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.
This approval is supported by data from the FRUSICA-2 study. FRUSICA-2 is a randomized, open-label, active-controlled registration study designed to evaluate the efficacy and safety of the combination therapy of fruquintinib and sintilimab versus axitinib or everolimus monotherapy as second-line treatment for advanced renal cell carcinoma. The study has met its primary endpoint of progression-free survival (PFS) assessed by blinded independent central review (BICR).
Professor Ye Dingwei from Fudan University Shanghai Cancer Center, a co-principal investigator of the FRUSICA-2 study, stated: “The rapid development of targeted therapy, immunotherapy, and their combinations has brought significant changes to the treatment landscape for advanced renal cell carcinoma. Optimizing individualized treatment options for patients is a key focus of current clinical practice. The approval of the combination therapy of fruquintinib and sintilimab highlights the potential of this regimen to address the urgent medical needs of patients with this challenging disease.”
Professor He Zhisong from Peking University First Hospital, another co-principal investigator of the FRUSICA-2 study, stated: “The results of the FRUSICA-2 study provide strong evidence that the combination therapy of fruquintinib and sintilimab is expected to play an important role in the second-line treatment strategy for advanced renal cell carcinoma. We are excited about the clinical significance of this approval and remain committed to providing effective treatment options for patients.”
Dr. Chi Haidong, Vice President of Eli Lilly and Chief Medical Officer of the China Drug Development and Medical Affairs Center, stated: “We are delighted to witness the approval of the new indication for fruquintinib in combination with sintilimab. This represents a significant breakthrough in the treatment of renal cell carcinoma and reflects the value of cross-enterprise collaborative innovation in accelerating the translation of scientific achievements into patient benefits. Eli Lilly is always committed to advancing scientific progress and looks forward to continuing to collaborate with local partners to promote more clinically meaningful innovative therapies, bringing hope to more cancer patients.”
Mr. Zheng Zefeng, Acting Chief Executive Officer and Chief Financial Officer of Hutchison China MediTech (Hutchmed), stated: “This approval reaffirms our firm commitment to providing innovative therapies for Chinese patients with advanced renal cell carcinoma. For these patients, second-line treatment options remain limited. We look forward to continuing to expand the boundaries of research, whether through monotherapy, combination therapy, or exciting new platforms such as ATTC technology, to explore broader therapeutic potential across multiple tumor types and deliver more impactful and transformative solutions for patients.”
Dr. Zhou Hui, Chief Research and Development Officer (Oncology Pipeline) of Innovent Biologics, stated: “This approval is an important milestone for Chinese patients with advanced renal cell carcinoma. It further validates the potential of the combination therapy of sintilimab and fruquintinib, which has now been approved for two difficult-to-treat cancers. We are also proud of the approval of the tenth indication for sintilimab (TYVYT®) and will continue to strive to enhance its clinical value to benefit a broader range of cancer patients.”