- Reduced risk of disease progression or death by 63%, with median PFS of 22.2 months in the FRUSICA-2 registration study
SAN FRANCISCO and SUZHOU, China, May 21, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), today jointly announce that the New Drug Application (NDA) for the combination of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has been 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 sintilimab in combination with fruquintinib 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 sintilimab and fruquintinib 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 sintilimab and fruquintinib 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."
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 our sintilimab (TYVYT®), and remain committed to advancing clinical value optimization to benefit an even broader population of cancer 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."
About The FRUSICA-2 Trial
Results from the Phase III part of the study were presented at the 2025 European Society for Medical Oncology (ESMO) Congress. As of the PFS final analysis cutoff of February 17, 2025, the median follow-up was 16.6 months. The median PFS as assessed by BICR was 22.2 months with sintilimab plus fruquintinib, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank p<0.0001). The objective response rate (ORR) was 60.5% vs 24.3% (Odds Ratio 4.622, p<0.0001), and the median duration of response (DoR) was 23.7 months vs 11.3 months, respectively. Overall survival data were still evolving at the time of data cutoff with maturity of approximately 20%. Efficacy benefits were observed in all prognostic risk groups, as defined by the International mRCC Database Consortium (IMDC) criteria. The safety profile of the sintilimab and fruquintinib combination was consistent with the known profiles of each individual treatment. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231.
About Kidney Cancer and Renal Cell Carcinoma
It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.[1] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.[2] Approximately 90% of kidney tumors are renal cell carcinoma.
About Sintilimab
Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[3]
About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.[4]
About Fruquintinib Approvals
Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor ("EGFR") therapy (RAS wild-type) in China. It was included in China's National Reimbursement Drug List ("NRDL") in January 2020.
The combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has conditional approval in China for the treatment of patients with advanced mismatch repair proficient ("pMMR") endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation.
Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. Fruquintinib received approval for the treatment of previously treated metastatic colorectal cancer in the US, Europe, Japan and many other countries around the world.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
References |
[1] The Global Cancer Observatory, kidney cancer fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf. Accessed February 19, 2025. |
[2] The Global Cancer Observatory, China fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed February 19, 2025. |
[3] Wang J, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. doi: 10.1080/19420862.2019.1654303. |
[4] Sun Q, et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. Cancer Biol Ther. 2014;15(12):1635-45. doi: 10.4161/15384047.2014.964087. |
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