VEGFR1 antagonists(Vascular endothelial growth factor receptor 1 antagonists), VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists), VEGFR3 antagonists(Vascular endothelial growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersUrogenital Diseases

Active Indication

Advanced Endometrial CarcinomaColorectal CancerMetastatic Colorectal Carcinoma+ [17]

Inactive Indication

Adenocarcinoma of large intestineAdvanced Colorectal AdenocarcinomaAdvanced gastric carcinoma+ [12]

Originator Organization

Hutchison MediPharma Ltd.

Active Organization

BeOne Medicines Ltd.

Hutchison MediPharma Ltd.Takeda Development Center Americas, Inc.

+ [9]

Inactive Organization-

License Organization

Eli Lilly & Co.

Takeda Pharmaceutical Co., Ltd.

BeOne Medicines Ltd.

+ [3]

Drug Highest PhaseApproved

First Approval Date

China (04 Sep 2018),

Metastatic Colorectal Carcinoma

RegulationFast Track (United States), Breakthrough Therapy (China), Orphan Drug (South Korea), Priority Review (United States), Conditional marketing approval (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC21H19N3O5

InChIKeyBALLNEJQLSTPIO-UHFFFAOYSA-N

CAS Registry1194506-26-7

249

Clinical Trials associated with Fruquintinib

NCT07124858

/ Not yet recruitingNot ApplicableIIT

PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer

The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.

Start Date01 Mar 2026

Sponsor / Collaborator

Fédération Francophone de la Cancérologie Digestive

ChiCTR2500115578

/ Not yet recruitingPhase 4IIT

TAS-102 plus Fruquintinib or TAS-102 plus Fruquintinib in combination with Chidamide and Serplulimab as third-line and beyond treatment for metastatic colorectal cancer：A multicenter, randomized, two-arm clinical trial

Start Date01 Jan 2026

Sponsor / Collaborator

The First Affiliated Hospital of Soochow University

NCT07150403

/ Not yet recruitingPhase 2IIT

A Phase II, Open-label, Non-comparative, Randomized Study of Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer

The standard second-line treatment for metastatic colorectal cancer (mCRC) involves chemotherapy (FOLFOX or FOLFIRI) combined with an antiangiogenic agent, such as bevacizumab or aflibercept. Maintaining VEGF inhibition between first and second-line treatments has shown modest clinical benefits, with exploratory analyses suggesting that bevacizumab is more effective in smaller tumors. The ULYSSE trial aims to evaluate the efficacy and safety of Fruquintinib, a potent antiangiogenic agent, combined with a doublet chemotherapy (FOLFOX or FOLFIRI) in second-line treatment for BRAF wild-type, MSS mCRC patients who have failed prior treatment.

Start Date31 Dec 2025

Sponsor / Collaborator

Fédération Francophone de la Cancérologie Digestive

100 Clinical Results associated with Fruquintinib

100 Translational Medicine associated with Fruquintinib

100 Patents (Medical) associated with Fruquintinib

229

Literatures (Medical) associated with Fruquintinib

31 Dec 2025·Human Vaccines & Immunotherapeutics

Durable response to third-line combination therapy in a metastatic colorectal cancer patient with BRAF V600E mutation: A case report

Article

Author: Qian, Xiaoping ; Li, Li ; Zhang, Qun

In metastatic colorectal cancer (mCRC), the BRAFV600E mutation subtype is one of the subtypes with the worst prognosis. The long-term abnormal activation of multiple signaling pathways caused by the BRAF V600E mutation is closely related to the formation of BRAF inhibitor resistance and drug-resistant tumor cell subpopulations. These factors significantly impact the survival and prognosis of CRC patients. Therefore, treating mCRC patients with the BRAFV600E mutation, particularly in later stages, is challenging. We reported a case of an mCRC patient with the BRAF V600E mutation in the primary and metastatic tumors. After the failure of second-line treatment, this patient received a combination therapy including immunotherapy (tislelizumab), radiotherapy, and targeted therapy (fruquintinib). Through comprehensive imaging evaluations and continuous monitoring of tumor markers, we were astonished to observe that the patient has achieved and maintained a complete response (CR) for over 12 months. This case supports the efficacy of combination therapy in mCRC patients with the BRAF V600E mutation.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

Author: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

01 Oct 2025·International Journal of Clinical Oncology

Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer: a FRESCO-2 subgroup analysis of patients enrolled in Japan

Article

Author: Eng, Cathy ; Ukrainskyj, Stacey ; Nanda, Shivani ; Yang, Zhao ; Komatsu, Yoshito ; Pallai, Rajash ; Esaki, Taito ; Kotani, Daisuke ; Nishina, Tomohiro ; Satoh, Taroh ; Takashima, Atsuo ; Yamazaki, Kentaro ; Masuishi, Toshiki ; Schelman, William ; Yoshino, Takayuki ; Sunakawa, Yu ; Kawakami, Hisato ; Kania, Marek

Abstract:

Background:

In the phase 3 FRESCO-2 study, fruquintinib plus best supportive care (BSC) significantly improved overall survival (OS) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). We present the results of a FRESCO-2 post hoc subgroup analysis evaluating outcomes of patients enrolled in Japan.

Methods:

In FRESCO-2, patients had previously received all standard chemotherapies, anti-VEGF and anti-EGFR therapies if indicated, and had progressed on, or were intolerant to trifluridine-tipiracil and/or regorafenib. Patients were randomized 2:1 to receive fruquintinib 5 mg or matching placebo by mouth once daily on days 1–21 in 28-day cycles, plus BSC. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and safety.

Results:

Of the 56 patients enrolled in Japan, 40 (71.4%) and 16 (28.6%) were randomized to fruquintinib and placebo, respectively. OS was improved with fruquintinib versus placebo (median 6.9 vs. 5.6 months; hazard ratio [HR], 0.42; 95% confidence interval [CI] 0.19 − 0.92). PFS was also improved with fruquintinib versus placebo (median 3.6 vs. 1.8 months; HR, 0.27; 95% CI 0.13 − 0.56). The incidence of grade ≥ 3 treatment-emergent adverse events (TEAEs) with fruquintinib versus placebo was 71.8% versus 29.4%; the most common grade ≥ 3 TEAEs with fruquintinib were hypertension (23.1%) and palmar-plantar erythrodysesthesia (17.9%).

Conclusions:

Fruquintinib improved OS and PFS versus placebo in FRESCO-2 patients enrolled in Japan and demonstrated a manageable safety profile. Results from the Japan subgroup were consistent with the global FRESCO-2 population, thus supporting fruquintinib as a novel treatment option for patients in Japan with refractory mCRC.

Clinical trial details:

ClinicalTrials.gov; NCT04322539.

176

News (Medical) associated with Fruquintinib

25 Dec 2025

·www.prnewswire.com

China's First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent's TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval

TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment of patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer. The TABOSUN® and TYVYT® combination therapy significantly improved pathological complete response (pCR) rates and enabled most patients to avoid the burden of postoperative adjuvant chemotherapy. This therapy is the first and only dual-IO regimen approved globally for neoadjuvant treatment of colon cancer[i], filling a critical gap in neoadjuvant treatment of colon cancer and benefiting more patients with MSI-H/dMMR colon cancer. SAN FRANCISCO and SUZHOU, China, Dec. 25, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for TABOSUN® (ipilimumab N01 injection; R&D Code: IBI310), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb), has been approved by China's National Medical Products Administration (NMPA), in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. TABOSUN® (ipilimumab N01 injection) is the world's first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer. Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination demonstrated a substantial improvement in pathological complete response, offering the potential to benefit a broader population of patients with MSI-H/dMMR colon cancer. Resectable MSI-H/dMMR colon cancer urgently requires effective neoadjuvant therapies to improve prognosis MSI-H/dMMR colon cancer accounts for around 15% of all resectable colon cancer cases[ii]. Due to its unique biological characteristics, this class of tumor shows limited sensitivity to chemotherapy and generally responds poorly[iii]. In recent years, immune checkpoint inhibitors have demonstrated significant efficacy in advanced MSI-H/dMMR colon cancer, but a gap remains in the neoadjuvant setting. For locally advanced MSI-H/dMMR colon cancer, the current standard of care is direct surgery followed by adjuvant chemotherapy. Under this regimen, approximately 10%-30% of patients experience disease recurrence or metastasis after surgery, while chemotherapy-related toxicities may negatively affect quality of life[iv]. Thus in the neoadjuvant setting, there remains an urgent need for more effective therapies to improve outcomes for patients with locally advanced MSI-H/dMMR colon cancer. The world ' s first dual-IO neoadjuvant therapy: TABOSUN ® (ipilimumab N01 injection) combined with TYVYT ® (sintilimab injection) markedly enhances pathological complete response rates Immune checkpoint blockade (ICB) therapy targeting PD-1 and CTLA-4 has transformed cancer treatment. The combination of DABOSUN® (ipilimumab N01 injection) and TYVYT® (sintilimab injection) as neoadjuvant therapy can significantly improve pathological complete response(pCR) rates and allow the majority of patients to avoid adjuvant chemotherapy. Previously, results from a randomized, controlled Phase 1b trial evaluating ipilimumab N01 plus sintilimab as neoadjuvant treatment for MSI-H/dMMR colon cancer were published in the top-tier journal Cancer Cell[i]. As of June 17, 2025, 101 patients were enrolled and randomized to receive ipilimumab N01 plus sintilimab (n=52) or sintilimab alone (n=49). In the per-protocol population, the pCR rate in the ipilimumab N01-plus-sintilimab arm was significantly higher than in the sintilimab-alone arm (80.0% vs 47.7%, p=0.0007). With median follow-up of 21.4 months, no patient experienced disease recurrence. Approval is based on results from the randomized, controlled, multicenter, pivotal Phase 3 clinical trial (NeoShot, NCT05890742), which evaluated the safety and efficacy of ipilimumab N01 combined with sintilimab as neoadjuvant therapy compared with direct radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pCR rate and event-free survival (EFS). Interim analysis by the Independent Data Monitoring Committee (IDMC) confirmed that the NeoShot trial met its primary endpoint. As of November 28, 2024, among the first 50 patients in the treatment arm, 41 achieved pathological complete response after neoadjuvant treatment, yielding a pCR rate of 82%. Neoadjuvant treatment with ipilimumab N01 combined with sintilimab did not significantly increase safety risks compared with direct surgery. Detailed results will be presented at future academic conferences or published in academic journals. The Principal Investigator of the NeoShot study, Academician of the Chinese Academy of Engineering, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated: "Achieving R0 resection remains challenging for certain patients with locally advanced colon cancer, who also face substantial surgical trauma and poor prognosis. Results from the FOxTROT study indicated that neoadjuvant chemotherapy provides limited benefit in MSI-H/dMMR colon cancer, with a pCR rate of only around 5%[v]. The NeoShot trial is the first randomized, controlled Phase 3 clinical trial to show promising efficacy of dual checkpoint inhibition as neoadjuvant therapy in MSI-H/dMMR colon cancer. Interim analysis suggests that ipilimumab N01 with sintilimab as short-term neoadjuvant treatment can lead to pathological complete response in 82% of treated patients. In addition, NeoShot Ph1b and Ph3 interim results both show the R0 resection under this regimen could reach 100% and spare patients from adjuvant chemotherapy. In NeoShot-1b, the dual-immunotherapy neoadjuvant regimen combining ipilimumab N01 and sintilimab significantly improved the pCR rate, which serves as a surrogate endpoint for long-term prognosis. Based on the existing data, this regimen shows promising potential to reduce recurrence risk and improve long-term survival outcomes. We look forward to observing continued reductions in recurrence with longer-term follow-up. The approval of this dual-immunotherapy regimen is expected to change clinical practice, fill a critical gap in neoadjuvant treatment of colon cancer and benefit more patients with MSI-H/dMMR colon cancer." Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "There remains a substantial unmet clinical need for neoadjuvant therapies for stage IIB-III resectable MSI-H/dMMR colon cancer in China. Interim analysis has shown that the NeoShot trial met its primary endpoint. Through Innovent's efficient and high-quality clinical development, ipilimumab N01 has become China's first domestically developed innovative CTLA-4 inhibitor approved by the NMPA, offering a new treatment option for patients in China with stage IIB-III resectable MSI-H/dMMR colon cancer." About Ipilimumab N01 Ipilimumab N01 (R&D code: IBI310) is a fully human monoclonal antibody injection independently developed by Innovent. Ipilimumab N01 specifically binds cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4-mediated inhibition of T cell activity, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. [vi] The NDA for ipilimumab N01 in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer has recently been approved by the NMPA. 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.[vii] In China, sintilimab has been approved and included in the updated NRDL for eight indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma; and In combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. The NDA for sintilimab's ninth indication, in combination with ipilimumab N01 as neoadjuvant treatment for stage IIB-III resectable MSI-H/dMMR colon cancer is recently approved by the NMPA. The NDA for sintilimab's tenth indication, in combination with fruquintinib for the treatment of locally advanced or metastatic renal cell carcinoma who previously failed systematic treatment, has been accepted by the Center for Drug Evaluation (CDE) of NMPA. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; and Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy. 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 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, 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 , or follow Innovent on Facebook and LinkedIn. Disclaimer: Innovent does not recommend any off-label usage. 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. Reference: SOURCE Innovent Biologics 21% more press release views with Request a Demo

Clinical ResultImmunotherapyPhase 3Drug ApprovalPhase 2

08 Dec 2025

·www.globenewswire.com

HUTCHMED Announces Expanded Coverage on National Reimbursement Drug List and Inclusion in the First Commercial Insurance Drug List in China

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 08, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2026 will continue to include ELUNATE®, ORPATHYS® and SULANDA®. In addition, TAZVERIK® will be included in the first edition of the National Commercial Health Insurance Innovative Drug List (“Commercial Insurance Drug List”). ELUNATE® (fruquintinib) is included for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, in combination with TYVYT® (sintilimab injection). It is also renewed 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 for receiving anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type). ORPATHYS® (savolitinib) is included for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 skipping alteration. SULANDA® (surufatinib) is renewed for the treatment of patients with unresectable; locally advanced or metastatic; progressive non-functional, well-differentiated (G1 or G2) pancreatic and non-pancreatic neuroendocrine tumors. TAZVERIK® (tazemetostat) is included in the Commercial Insurance Drug List for the treatment of adult patients with relapsed or refractory follicular lymphoma with EZH2 mutation who have received at least two prior systemic therapies. In July 2025, the NHSA issued the 2025 Adjustment Work Plan for the NRDL and the Commercial Health Insurance Innovative Drug List, announcing the establishment of the new Commercial Insurance Drug List. This list, together with the NRDL, forms a key component of China’s multi-level medical insurance system. This new list focuses on medicines with high innovation and significant clinical value that fall beyond the scope of basic medical insurance, including certain high-cost oncology drugs, gene therapies, and rare disease therapies, enabling reimbursement through commercial health insurance products such as high-limit medical insurance, inclusive health plans (“Huiminbao”) and group health insurance. This multi-layered reimbursement framework enhances patient access to breakthrough treatments while supporting the sustainable development of China’s innovative pharmaceutical sector. About NRDL The government in China has placed great importance on improving the affordability of drug treatments for the public. As of end of 2024, 1.33 billion people in China had basic medical insurance coverage, representing around 95% of the entire population. The NRDL is updated every year, and inclusion on the list is subject to renewal every two years. The NHSA annually convenes a broad network of experts in medicine, pharmacology, pharmacoeconomics and actuarial valuation to identify innovative medicines to consider for NRDL inclusion. Reimbursement of Category B medicines, including novel oncology medicines, requires varying degrees of copayment from patients, depending on their provinces or types of NHSA insurance scheme enrollment. About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. 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®. About Savolitinib Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS®. About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide. About Tazemetostat Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, an Ipsen company. HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize tazemetostat in Chinese Mainland, Hong Kong, Macau and Taiwan. 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 press release contains forward-looking statements within the meaning of 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 its expectations for the commercialization of fruquintinib, savolitinib, surufatinib and tazemetostat in China, the potential benefits and further clinical development of fruquintinib, savolitinib, surufatinib and tazemetostat, its expectations as to whether further studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the commercial acceptance of fruquintinib, savolitinib, surufatinib and tazemetostat, the impact of the inclusion of fruquintinib, savolitinib and surufatinib on the NRDL and tazemetostat on the Commercial Health Insurance Innovative Drug List on sales of the drug and its pricing, clinical trial enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of fruquintinib, savolitinib, surufatinib and tazemetostat to obtain regulatory approval for a targeted indication in different jurisdictions and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on 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 This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Tim Stamper+44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

License out/inImmunotherapyDrug Approval

07 Dec 2025

·www.prnewswire.com

Innovent Announces Inclusion of Seven Innovative Drugs including TYVYT New Indication and SYCUME in China's National Reimbursement Drug List

SAN FRANCISCO and SUZHOU, China, Dec. 6, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that seven of its innovative products have been included in the updated 2025 National Reimbursement Drug List (NRDL). This list features a new indication of TYVYT® (sintilimab injection), and first-time inclusions of SYCUME® (teprotumumab N01 injection, a recombinant anti-IGF-1R antibody), Limertinib (EGFR TKI), Dupert® (fulzerasib, KRAS G12C inhibitor), DOVBLERON® (taletrectinib, ROS1 inhibitor), Retsevmo® (selpercatinib, RET inhibitor), and Jaypirca® (pirtobrutinib, BTK inhibitor). The updated NRDL will be officially effective from January 1, 2026. Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We are pleased with the NRDL inclusion of our seven innovative therapies this year. These therapies cover key disease areas that pose substantial public health challenges in China—particularly oncology (including lung, liver, gastric, esophageal, gynecological cancers, and hematological malignancies) as well as cardiovascular and metabolic (CVM) diseases. Their inclusion will help broaden patients' access to and enhance their affordability of these medications, ultimately benefiting more individuals and families across the country. As a company with the mission of 'empowering patients worldwide with affordable, high-quality biopharmaceuticals', Innovent continues to invest in pioneering treatments across oncology, CVM, autoimmune and ophthalmology—areas of significant societal need. We remain committed to our patient-centered approach, leveraging our innovation and product capabilities to further improve drug affordability and accessibility, so that high-quality medicines can reach and benefit more patients and their families as soon as possible. We are proud to contribute to better care for our patients." TYVYT® (sintilimab injection) TYVYT® (sintilimab injection) is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. In China, sintilimab has been approved for eight indications and two more NDAs are under review by the NMPA, including squamous non-small cell lung cancer (NSCLC), non-squamous NSCLC, liver cancer, gastric cancer, esophageal cancer, endometrial cancer and Hodgkin's lymphoma[i]. In the updated NRDL, the eighth indication of TYVYT®(sintilimab injection) is newly included, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. This new indication addresses a critical gap in treatments available for advanced endometrial cancer patients with limited responses to traditional therapies. SYCUME® (teprotumumab N01 injection) SYCUME® (teprotumumab N01 injection) is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody developed by Innovent. SYCUME® blocks the activation of IGF-1R signaling pathway, consequently improving clinical manifestations such as proptosis, inflammation and diplopia, thus enhancing quality of life in patients with thyroid eye disease (TED)[ii]. In the updated NRDL, SYCUME®(teprotumumab N01 injection) is newly listed for moderate-to-severe thyroid eye disease. SYCUME®(teprotumumab N01 injection) is China's first approved IGF-1R antibody drug, and this groundbreaking non-invasive therapy redefines the standard of care and serves the unmet needs for thyroid eye disease over past 70 years in China. The NRDL inclusion will bring this world-class novel treatment option to Chinese patients with thyroid eye disease and significantly enhance patient accessibility and affordability. Limertinib Limertinib is a third-generation EGFR TKI in collaboration with ASK Pharm, and Innovent holds exclusive commercialization rights in Mainland China.[iii] In the updated NRDL, limertinib is newly listed for: 1) the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), who have previously experienced disease progression during or after treatment with EGFR TKI; and 2) the first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations. Limertinib incorporates a unique naphthylamine group structure, which endows it with enhanced lipophilicity. This property ensures effective drug penetrate across the blood-brain barrier (BBB), thereby significantly reducing the risk of disease progression—specifically, the risk of disease progression in patients with brain metastases and the risk of intracranial disease progression. The NRDL inclusion of limertinib will provide a more effective treatment option for NSCLC patients with EGFR mutations. Dupert® (fulzerasib) Dupert® (fulzerasib) is a novel KRAS G12C inhibitor in collaboration with GenFleet Therapeutics, and Innovent holds exclusive development and commercialization rights in Greater China.[iv] In the updated NRDL, Dupert®(fulzerasib) is newly listed for the treatment of advanced NSCLC adult patients harboring KRAS G12C mutation who have received at least one systemic therapy. The NRDL inclusion of Dupert®(fulzerasib) will provide a novel targeted therapy benefiting NSCLC patients harboring KRAS G12C mutation. DOVBLERON® (taletrectinib) DOVBLERON® (taletrectinib) is a novel next-generation ROS1 TKI in collaboration with Nuvation Bio China, a Nuvation Bio (NYSE: NUVB) Company, and Innovent holds exclusive commercialization rights in Greater China.[v] In the updated NRDL, DOVBLERON® (taletrectinib) is newly listed for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The NRDL inclusion of DOVBLERON® (taletrectinib) will provide a potentially best-in-class therapy benefiting patients with locally advanced ROS1-positive NSCLC. Retsevmo® (selpercatinib) Retsevmo® (selpercatinib) is a selective and potent rearranged during transfection (RET) kinase inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent.[vi] In the updated NRDL, Retsevmo® (selpercatinib) is newly listed for the treatment of: 1) adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, 2) adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, and 3) adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory. Retsevmo® (selpercatinib) is the first RET inhibitor approved globally and its NRDL inclusion will bring an innovative therapy for NSCLC and thyroid cancer patients with a RET alteration. Jaypirca® (pirtobrutinib) Jaypirca® (pirtobrutinib) is a non-covalent (reversible) BTK inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent. Jaypirca® (pirtobrutinib) is the first and only non-covalent (reversible) BTK inhibitor approved in the world.[vii] In the updated NRDL, Jaypirca® is newly listed for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor. Its NRDL inclusion will benefit heavily-treated MCL patients that previously received the treatment of a BTK inhibitor, addressing their unmet needs and further enhancing Jaypirca's affordability for those patients. 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 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli 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 , or follow Innovent on Facebook and LinkedIn. Statements: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Ramucirumab（Cyramza）, Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. 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. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 materialise or turn out to be incorrect. SOURCE Innovent Biologics 21% more press release views with Request a Demo

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	China	Hutchison MediPharma Ltd.	01 Dec 2024
Colorectal Cancer	Japan	Takeda Pharmaceutical Co., Ltd.	24 Sep 2024
Metastatic Colorectal Carcinoma	China	Hutchison MediPharma Ltd.	04 Sep 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Renal Cell Carcinoma	NDA/BLA	China	Hutchison MediPharma Ltd.	05 Jun 2025
Metastatic Renal Cell Carcinoma	NDA/BLA	China	Hutchison MediPharma Ltd.	05 Jun 2025
Gastroesophageal junction adenocarcinoma	NDA/BLA	China	Hutchison MediPharma Ltd.	18 Apr 2023
Stomach Cancer	NDA/BLA	China	Hutchison MediPharma Ltd.	18 Apr 2023
Metastatic gastric adenocarcinoma	Phase 3	France	Takeda Development Center Americas, Inc.	31 Dec 2025
Metastatic gastric adenocarcinoma	Phase 3	Germany	Takeda Development Center Americas, Inc.	31 Dec 2025
Advanced Renal Cell Carcinoma	Phase 3	China	Hutchison MediPharma Ltd.	14 Oct 2022
Renal Cell Carcinoma	Phase 3	China	Hutchison MediPharma Ltd.	14 Oct 2022
Metastatic colon cancer	Phase 3	United States	Hutchison MediPharma Ltd.	12 Aug 2020
Metastatic colon cancer	Phase 3	Japan	Hutchison MediPharma Ltd.	12 Aug 2020

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06685276 (CAPability-01, ESMO_ASIA2025)	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma Third line MSS \| pMMR	50	Fruquintinib+PD-1 inhibitor+Chidamide	szkpjfdvgt(fkwgqqjhxh) = mhemexvmvf eynuonsdbb (vhajzzgfln, 1.60 - 7.23) View more	Positive	05 Dec 2025
				Bevacizumab+PD-1 inhibitor+Chidamide	szkpjfdvgt(fkwgqqjhxh) = rinyuxqbmg eynuonsdbb (vhajzzgfln, 2.0 - 4.90) View more
NCT06169202 (ESMO_ASIA2025)	Not Applicable	Advanced Colorectal Adenocarcinoma Second line mutated RAS gene	21	Fruquintinib + irinotecan + capecitabine	bxyhzeyoda(ydtpnyuesm) = uebsciopmc zadqtbtsps (iozfxfmpzx, 7.26 - NA) View more	Positive	05 Dec 2025
NCT05522231 (FRUSICA-2, ESMO_ASIA2025)	Phase 2/3	Locally Advanced Renal Cell Carcinoma Second line	31	Fruquintinib 5 mg	pjnkevfblm(cjojguchcq) = pnhbrvapai fjhjddtahz (pknqloveow, 19.23 - 54.63) View more	Positive	05 Dec 2025
NCT05522231 (FRUSICA-2, ESMO2025) Manual	Phase 3	Locally Advanced Renal Cell Carcinoma Second line	234	Fruquintinib + Sintilimab	lzspczcruf(krnzboqylo) = oghnarylvw jdgahnmcep (qpydpweiel ) View more	Superior	17 Oct 2025
				Axitinib / Everolimus	lzspczcruf(krnzboqylo) = xinowiheop jdgahnmcep (qpydpweiel ) View more
NCT04322539 (FRESCO-2, ESMO2025)	Phase 3	Metastatic Colorectal Carcinoma tumour vascularity and heterogeneity radiomics	215	Fruquintinib	jlokcmeojb(esluiktdcd): HR = 0.47 (95.0% CI, 0.25 - 0.9), P-Value = 0.023	Positive	17 Oct 2025
				Placebo
NCT02196688 (FRESCO, ESMO2025)	Phase 2/3	Metastatic Colorectal Carcinoma	1,172	Fruquintinib 5 mg + Fruquintinib 5 mgare	ctfpqzotxt(pbewexznku) = txtctvkvbh mmtrcdijqo (mfgymuseyx ) View more	Positive	17 Oct 2025
				Placebo + Best supportive care	ctfpqzotxt(pbewexznku) = ytvzedphkw mmtrcdijqo (mfgymuseyx ) View more
NCT04577963 (ESMO2025)	Phase 1/2	Microsatellite Stable Colorectal Carcinoma Third line MSS	39	Fruquintinib + tislelizumab	xofhfbolez(ccykfwpyug) = zrxcgslwyr wpwkaqgazc (iegvdocztd, 37.2 - 69.9) View more	Positive	17 Oct 2025
				Fruquintinib + tislelizumab (liver mets at BL)	xofhfbolez(ccykfwpyug) = qskxpjnaoy wpwkaqgazc (iegvdocztd, 24.4 - 65.1) View more
NCT05177068 (ESMO2025)	Phase 2	Gastroesophageal junction adenocarcinoma First line	42	Fruquintinib + Sintilimab + SOX	agnmgcmrcu(axxlzkgajb) = pwuairatwf csnnyhdwwu (dppttmtjws ) View more	Positive	17 Oct 2025
				Fruquintinib + Sintilimab + SOX (Surgical group)	qpmcunvbzz(irczbvuezp) = uiasfzxgfv mrbvlgeofv (drfbzjmarp ) View more
NCT05659290 (ESMO2025)	Phase 2	Metastatic Colorectal Carcinoma Maintenance	40	Fruquintinib + Bevacizumab + Capecitabine	meqanzlitm(kkerdlwnlf) = pkkfxpylwl hlzqpqsozw (ltaocjshii, 4.34 - NA)	Positive	17 Oct 2025
				Fruquintinib + Bevacizumab + Capecitabine (phase IIb)	ijoolcbrbs(cenvpptfgh) = mjapkfmhtq cebsxfjogi (djagqjteqs ) View more
NCT06218888 (ESMO_IO2025)	Phase 2	Colorectal Liver Metastases Last line pMMR \| MSS	14	Tislelizumab combined with fruquintinib and chidamide (pMMR/MSS colorectal cancer with liver metastases)	mjnfoipkdq(jcxochgweh) = ugnjqjzxqe gchujcvljc (dgvqkxppzf ) View more	Positive	12 Oct 2025

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