— In the FRUSICA-2 registration study, risk of disease progression or death reduced by 63%, with median progression-free survival of 22.2 months
SAN FRANCISCO and SUZHOU, ChinaMay 21, 2026 /PRNewswire/ — Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic and ophthalmology, and HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/LSE: HCM; HKEX: 13) jointly announced that the New Drug Application (NDA) for the combination therapy of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has been approved by China’s National Medical Products Administration (NMPA). The approval is for the treatment of patients with locally advanced or metastatic renal cell carcinoma (RCC) who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) therapy and have not received prior PD-1 or PD-L1 inhibitors in the first-line setting.
This approval is supported by data from the FRUSICA-2 study. FRUSICA-2 is a randomized, open-label, positive-controlled registration study designed to evaluate the efficacy and safety of sintilimab in combination with fruquintinib versus axitinib or everolimus monotherapy as second-line treatment for advanced RCC. The study met its primary endpoint of progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).
Professor Dingwei Ye of Fudan University Shanghai Cancer Center, co-principal investigator of the FRUSICA-2 study, stated: “The rapid development of targeted therapy, immunotherapy and their combinations has significantly transformed the treatment landscape for advanced RCC. Optimizing individualized treatment options for patients is a key focus in current clinical practice. The approval of the fruquintinib and sintilimab combination highlights its potential to address the urgent medical needs of patients with this challenging disease.”
Professor Zhisong He of Peking University First Hospital, co-principal investigator of the FRUSICA-2 study, stated: “The results of the FRUSICA-2 study provide strong evidence that the combination of fruquintinib and sintilimab has the potential to play an important role in second-line treatment strategies for advanced RCC. We are very encouraged by the clinical significance of this approval and remain committed to providing effective treatment options for patients.”
Dr. Hui Zhou, Senior Vice President of Oncology at Innovent, stated: “This approval is an important milestone for patients with advanced RCC in China. It further validates the potential of the sintilimab and fruquintinib combination, which is now approved in two difficult-to-treat cancers. We are also proud that this marks the tenth approved indication for sintilimab (TYVYT®) and will continue to strive to enhance its clinical value to benefit a broader range of cancer patients.”
Mr. Zefeng Zheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, stated: “This approval reaffirms our strong commitment to bringing innovative therapies to patients with advanced RCC in China, for whom second-line treatment options remain limited. We look forward to continuing to push the boundaries of research, whether through monotherapy, combination therapies, or exciting new platforms such as ATTC technology, to unlock broader therapeutic potential across multiple tumor types and deliver more impactful and transformative solutions for patients.”
About the FRUSICA-2 Study
Results from the Phase III portion of the FRUSICA-2 study were presented at the 2025 European Society for Medical Oncology (ESMO) Congress. As of the PFS final analysis cutoff date of February 17, 2025, with a median follow-up of 16.6 months, the BICR-assessed median PFS was 22.2 months in the sintilimab plus fruquintinib arm versus 6.9 months in the axitinib/everolimus arm (stratified hazard ratio [HR] 0.373; stratified log-rank test p <0.0001). Objective response rate (ORR) was 60.5% versus 24.3% (odds ratio 4.622, p <0.0001), and median duration of response (DoR) was 23.7 months versus 11.3 months. Overall survival (OS) data were still maturing at the data cutoff, with approximately 20% maturity. Efficacy benefits were observed across all prognostic risk groups defined by the International Metastatic RCC Database Consortium (IMDC) criteria. The safety profile of the sintilimab and fruquintinib combination was consistent with the known characteristics of each agent. Further details of the study can be found on clinicaltrials.gov under registration number NCT05522231.
About Kidney Cancer and Renal Cell Carcinoma
Globally, an estimated 435,000 new cases of kidney cancer were diagnosed in 2022.[1] In China, an estimated 74,000 new cases of kidney cancer were diagnosed in 2022.[2] Renal cell carcinoma accounts for approximately 90% of all kidney cancer cases.
About Sintilimab
Sintilimab, marketed in China as TYVYT® (sintilimab injection), is an innovative PD-1 immunoglobulin G4 (IgG4) monoclonal antibody co-developed by Innovent Biologics and Eli Lilly and Company. It binds specifically to PD-1 molecules on the surface of T cells, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance and reactivating the anti-tumor activity of lymphocytes to achieve tumor treatment.[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 crucial role in inhibiting tumor angiogenesis. Fruquintinib is designed to have higher kinase selectivity, aiming to reduce off-target kinase activity, thereby achieving drug exposure, sustained target coverage, and greater flexibility when potentially used in combination therapies.[4]
About Fruquintinib Approvals
In China, fruquintinib is co-developed and commercialized by HUTCHMED and Eli Lilly and Company, and marketed under the brand name ELUNATE®. Fruquintinib has been approved in China for the treatment of metastatic colorectal cancer (mCRC) in patients who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and who have received or are not suitable for prior anti-VEGF therapy and anti-EGFR therapy (RAS wild-type). It was included in the China National Reimbursement Drug List (NRDL) in January 2020.
The combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has received conditional approval in China for the treatment of advanced mismatch repair proficient (pMMR) endometrial cancer in patients who have failed prior systemic anti-tumor therapy and are not candidates for curative surgery or radiotherapy.
Takeda has an exclusive global license to further develop, commercialize and manufacture fruquintinib outside of mainland China, Hong Kong and Macau, and markets it under the brand name FRUZAQLA®. Fruquintinib has been approved in the United States, Europe, Japan and multiple other countries worldwide for the treatment of previously treated mCRC.
About Innovent Biologics
“Start with Integrity, Succeed through Action” – Innovent’s mission is to develop and deliver high-quality biopharmaceuticals that are affordable to ordinary people. Founded in 2011, Innovent is dedicated to the research, development, manufacturing and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic and ophthalmology, benefiting more lives with our work. The company has 18 approved products: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection), SULINNO® (adalimumab injection), HALPRYZA® (rituximab injection), PEMAZYRE® (pemigatinib tablets), NAILEXI® (olverembatinib tablets), CYRAMZA® (ramucirumab injection), RETEVMO® (selpercatinib capsules), FUCASO® (equecabtagene autoleucel injection), XINBILA® (tafolecimab injection), DABERT® (fulzerasib tablets), JEPARLI® (pirtobrutinib tablets), DABOLE® (taletrectinib adipate capsules), AOYIXIN® (liretinib tablets), XINBIMIN® (teprotumumab N01 injection), XINERMEI® (mazdutide injection), DABOXIN® (ipilimumab N01 injection) and XINMEIYUE® (pikankibart). Currently, 5 new molecular entities are in Phase III or pivotal clinical studies, and an additional 14 new drug candidates are in clinical development.
The company has established over 30 strategic collaborations with international partners such as Eli Lilly, Roche, Takeda, Sanofi, Incyte and MD Anderson Cancer Center. While continuously innovating and developing its own drugs and pursuing growth, Innovent adheres to a people-centered development philosophy in economic construction. Over the years, always guided by scientific conscience and committed to a “patient-first” approach, the company cares for patients and their families and actively fulfills its social responsibilities. The company has initiated and participated in multiple drug assistance programs, enabling more patients to benefit from advances in life sciences and to access and afford high-quality biopharmaceuticals. To date, Innovent’s patient assistance programs have benefited over 200,000 ordinary patients, with a total drug donation value of RMB 3.6 billion. Innovent hopes to work together with everyone to improve the level of China’s biopharmaceutical industry, to meet the people’s need for accessible medicines and their aspiration for a healthy life.
For more information, please visit the company’s website: www.innoventbio.com or follow our LinkedIn page.
1. Innovent does not recommend the use of unapproved drugs/indications
2. This content is solely for the purpose of information sharing, and does not constitute a recommendation, advertisement or promotion of any drug or treatment regimen. Unauthorized reproduction or use for other purposes is prohibited.
3. CYRAMZA® (ramucirumab injection), RETEVMO® (selpercatinib capsules) and JEPARLI® (pirtobrutinib tablets) are developed by Eli Lilly and Company.
About HUTCHMED
HUTCHMED (Nasdaq/LSE: HCM; HKEX: 13) is a commercial-stage innovative biopharmaceutical company dedicated to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immune diseases. Since its inception, HUTCHMED has been committed to bringing its internally discovered drug candidates to patients worldwide. Its first three drugs are now marketed in China, with the first also approved in the United States, Europe, Japan and other global markets. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
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References
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[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. |