Here is the English translation of the Chinese title: **Hutchison China MediTech and Innovent Biologics Announce China NMPA Approval of Combination Therapy of Elunate® (Fruquintinib) and Tyvyt® (Sintilimab Injection) for the Treatment of Patients with Advanced or Metastatic Renal Cell Carcinoma**

— In the FRUSICA-2 registrational study, disease progression or death risk reduced by 63%, with median progression-free survival of 22.2 months —

Hong Kong, Shanghai, and Florham Park, New JerseyMay 26, 2026 /PRNewswire/ — Hutchmed (China) Limited (“Hutchmed” or “HUTCHMED”) (Nasdaq/LSE: HCM; HKEx: 13) and Innovent Biologics, Inc. (“Innovent”) (HKEx: 1801) today jointly announced that the New Drug Application for the combination therapy of ELUNATE^® (fruquintinib) and TYVYT^® (sintilimab injection) has been approved by China’s 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 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, a randomized, open-label, active-controlled registrational trial evaluating the efficacy and safety of the fruquintinib and sintilimab combination 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, Co-Principal Investigator of the FRUSICA-2 study and affiliated with Fudan University Shanghai Cancer Center, 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 clinical focus. The approval of the fruquintinib and sintilimab combination highlights the potential of this regimen to address the urgent medical needs of patients with this challenging disease.”

Professor He Zhisong, Co-Principal Investigator of the FRUSICA-2 study and affiliated with Peking University First Hospital, stated: “The results of the FRUSICA-2 study provide strong evidence that the fruquintinib and sintilimab combination has the potential to play an important role in second-line treatment strategies for advanced renal cell carcinoma. We are optimistic about the clinical significance of this approval and remain committed to providing effective treatment options for patients.”

Mr. Zheng Zefeng, Acting Chief Executive Officer and Chief Financial Officer of Hutchmed, stated: “This approval reaffirms our firm commitment to delivering innovative therapies for patients with advanced renal cell carcinoma in China, where 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 unlock broader therapeutic potential across multiple tumor types and bring more impactful and transformative solutions to patients.”

Dr. Zhou Hui, Chief Medical Officer (Oncology Pipeline) of Innovent, stated: “This approval is a significant milestone for patients with advanced renal cell carcinoma in China. It further validates the potential of the sintilimab and fruquintinib combination, 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 advance its clinical value to benefit a broader range of cancer 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 fruquintinib plus sintilimab group versus 6.9 months in the axitinib/everolimus group (stratified hazard ratio [HR] 0.373; stratified log-rank test p <0.0001). The objective response rate (ORR) was 60.5% versus 24.3% (odds ratio 4.622, p <0.0001), and the median duration of response (DoR) was 23.7 months versus 11.3 months. As of the data cutoff, overall survival data were still maturing, with approximately 20% maturity. Efficacy benefits were observed across all prognostic risk groups per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria. The fruquintinib and sintilimab combination demonstrated a safety profile consistent with the known characteristics of each treatment. 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 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 as part of a combination therapy.^[3]

About Fruquintinib Approvals

In China, fruquintinib is co-developed and commercialized by Hutchmed and Eli Lilly and Company, marketed under the brand name ELUNATE^®. Fruquintinib has been approved in China for the treatment of metastatic colorectal cancer in patients who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and who have received or are not suitable for anti-VEGF therapy and anti-EGFR therapy (RAS wild-type). It was included in China’s National Reimbursement Drug List in January 2020.

The combination therapy of ELUNATE^® (fruquintinib) and TYVYT^® (sintilimab injection) has been conditionally approved 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 suitable for curative surgery or radiotherapy.

Takeda holds the global exclusive 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 metastatic colorectal cancer.

About Sintilimab

Sintilimab, marketed in China under the brand name TYVYT^® (sintilimab injection), is an innovative PD-1 immunoglobulin G4 (IgG4) monoclonal antibody co-developed by Innovent Biologics and Eli Lilly and Company. It specifically binds to PD-1 molecules on the surface of T cells, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance, reactivating the anti-tumor activity of lymphocytes to achieve tumor treatment.^[4]

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 self-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 regions. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

About Innovent

“Starting with integrity, succeeding through action” – developing high-quality biologics that are affordable for the people is the mission and goal of Innovent. Founded in 2011, Innovent is dedicated to the research, development, manufacture, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune, metabolic, and ophthalmology, to benefit more lives. Innovent has 18 products approved for marketing, 4 new drug molecules in Phase III or pivotal clinical studies, and an additional 15 products in clinical development. Innovent has established over 30 strategic collaborations with international partners to jointly enhance drug accessibility and improve patient quality of life.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Hutchmed’s current expectations regarding future events, including expectations regarding the therapeutic potential of fruquintinib, further clinical study plans for fruquintinib, expectations regarding whether studies of fruquintinib will meet their primary or secondary endpoints, and expectations regarding the timing of completion and release of results of such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include assumptions regarding enrollment rates, timing and availability of subjects meeting study inclusion and exclusion criteria; changes in clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the efficacy of fruquintinib (including as a combination therapy) in meeting study primary or secondary endpoints; obtaining regulatory approvals in different jurisdictions and marketing authorizations following regulatory approval; the potential market for fruquintinib for its target indications; and the ability of Hutchmed and/or its partners to fund and complete further clinical development plans and commercialization of fruquintinib and the timing of such events. In addition, because some studies rely on the use of other drug products (such as sintilimab) in combination with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply, and regulatory approval of these therapeutic drugs. Current and potential investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. For further discussion of these and other risks, please refer to Hutchmed’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited, and the AIM. Hutchmed undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances, or otherwise.

Medical Information

The products mentioned in this press release may not be available in all countries, or may be marketed under different trademarks, for different indications, in different dosages, or with different potencies. Nothing contained herein should be considered a solicitation, promotion, or advertisement for any prescription drug, including those under development.