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+ [11]

Inactive Indication

Adenocarcinoma of large intestineAdvanced Colorectal AdenocarcinomaAdvanced gastric carcinoma+ [13]

Originator Organization

Hutchison MediPharma Ltd.

Active Organization

Hutchison MediPharma Ltd.

Takeda Pharmaceutical Co., Ltd.Wuhan Xiehe Hospital Tower

+ [8]

Inactive Organization-

License Organization

Eli Lilly & Co.

Takeda Pharmaceutical Co., Ltd.

BeiGene Ltd.

+ [3]

Drug Highest PhaseApproved

First Approval Date

China (04 Sep 2018),

Metastatic Colorectal Carcinoma

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

Structure/Sequence

Molecular FormulaC21H19N3O5

InChIKeyBALLNEJQLSTPIO-UHFFFAOYSA-N

CAS Registry1194506-26-7

185

Clinical Trials associated with Fruquintinib

NCT05690035

/ WithdrawnPhase 2IIT

PD-1 Antibody (Tislelizumab) Combined With VEGFR 1/2/3 Inhibitor (Fruquintinib) for ARID1A-mutated Metastatic pMMR/MSS Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial

This is an open-label phase II study, with the aim of investigating the efficacy and safety of Tislelizumab + Fruquintinib combination therapy in ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan. Patients with hypermutated CRC that carries POLE/POLD1 mutations cannot be included.

Start Date01 Jul 2025

Sponsor / Collaborator

Sun Yat-Sen University

[+2]

NCT06973421

/ Not yet recruitingPhase 2IIT

Preliminary Phase II Clinical Study on the Efficacy and Safety of the Combination of Utidelone Capsules and Fruquintinib Capsules in the Treatment of Platinum Resistant Recurrent Ovarian Cancer

This study is a Prospective, Single-arm, Phase 2 clinical trial. The purpose of this study is to find out if taking Utidelone Capsules together with Fruquintinib Capsules is safe and works well for people with platinum-resistant ovarian cancer . Researchers will look at the Objective Response Rate, Progression-Free Survival, Overall Survival, safety, and any side effects.

Start Date01 Jul 2025

Sponsor / Collaborator

Fudan University

NCT06977061

/ Not yet recruitingPhase 2/3IIT

A Single-Arm, Open-Label Phase II Clinical Study of Fruquintinib Combined With Sintilimab and Stereotactic Body Radiation Therapy (SBRT) for the Second-Line and Higher-Line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Oligometastatic Progression

Efficacy and safety of fruquintinib in combination with sintilizumab and SBRT in the treatment of oligonadenocarcinoma progression in the stomach or gastroesophageal junction

Start Date01 Jun 2025

Sponsor / Collaborator

The Second Affiliated Hospital of Nanchang University

100 Clinical Results associated with Fruquintinib

100 Translational Medicine associated with Fruquintinib

100 Patents (Medical) associated with Fruquintinib

224

Literatures (Medical) associated with Fruquintinib

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.

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.

01 May 2025·Therapeutic Advances in Gastroenterology

Partial response to posterior line immunotherapy for more than 15 months in a pMMR patient with cutaneous metastasis of rectal carcinoma: a case report

Article

Author: Li, Jing-Jing ; Nie, Yan-Li ; Xu, Peng-Fei

The vast majority of colorectal cancers (CRCs) are proficient mismatch repair (pMMR) and microsatellite stable, and their immune microenvironment appears as a “cold tumor,” which is not sensitive to single immunotherapy based on immune checkpoint inhibitors (ICIs). The utilization of ICIs in pMMR advanced CRC is still in the exploratory phase. Cutaneous metastasis from colorectal carcinoma is extremely rare, presenting with diverse clinical manifestations, and there is a lack of standard treatment options for such cases. Patients with skin metastasis from CRC usually progress rapidly and are associated with a dismal prognosis. Herein, we report the case of a 66-year-old woman with extensive cutaneous metastasis of pMMR advanced rectal carcinoma. The patient presented to the abdominal oncology clinic with a complaint of erythema on the right lower limb, perineum, and abdominal skin. The patient underwent radical surgery for rectal carcinoma 3 years before the presentation. The histologic examination revealed low-grade squamous cell subepithelial adenocarcinoma. The patient was treated with sintilizumab in combination with fruquintinib, which exhibited remarkable efficacy and improved the patient’s quality of life significantly. Previous cases of cutaneous metastasis of colorectal carcinoma were retrieved to characterize the clinicopathological features. For the rare subset of patients with skin metastasis from CRC, immunotherapy combined with anti-angiogenic targeted therapy may be considered.

160

News (Medical) associated with Fruquintinib

23 May 2025

·www.einpresswire.com

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA. Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China. Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system (“CNS”) activity, with reduced CNS progression and fewer new CNS lesions. Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (“IDH”) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate (“ORR”) of 7.1% and a disease control rate (“DCR”) of 100%. Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee (“IRC”)-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy (“NACT/ACT”) showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively. Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET -amplification ( MET amp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China LBA8505 Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Sunday, June 1, 2025 9:48 AM CDT Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 8513 Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic Monday, June 2, 2025 8:06 AM CDT Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX 2013 Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025 3:06 PM CDT Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China 5596 Poster Session: Gynecologic Cancer The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 Jing Wang, Hunan Cancer Hospital, Changsha, China 5611 Poster Session: Gynecologic Cancer Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study Yi Wang, Ningbo No.2 Hospital, Ningbo, China e15512 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China e15515 Publication Only: Gastrointestinal Cancer - Colorectal and Anal The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China e16011 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China e16012 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary INVESTIGATOR-INITIATED STUDIES Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 4042 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China 4046 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China TPS4203 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China e15530 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Ling Xu, the First Hospital of China Medical University, Shenyang, China e15539 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China e15541 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China e15550 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial Fei Ma, Henan Cancer Hospital, Zhengzhou, China e16016 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China e23506 Publication Only: Sarcoma Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 4028 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China 4157 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China 4161 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China 5589 Poster Session: Gynecologic Cancer The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China e16209 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China e16222 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results from a multicenter, single-arm Phase II study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China e16342 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China e16442 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary 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 US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, ranosidenib, fruquintinib and surufatinib, the further clinical development for savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to whether any studies on savolitinib, ranosidenib, fruquintinib and surufatinib 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. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the 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 savolitinib, ranosidenib, fruquintinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib, ranosidenib, fruquintinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products 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.com Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultPhase 2ASCOPhase 3Phase 1

12 May 2025

·ir.cytomx.com

CytomX Announces Positive Interim Data From Phase 1 Dose Escalation Study of EpCAM Antibody Drug Conjugate (CX-2051) Candidate in Patients with Advanced Colorectal Cancer (CRC)

- 28% confirmed response rate (5/18) per RECIST v1.1 in unselected patients across doses prioritized for expansion (7.2, 8.6 and 10 mg/kg Q3W) - - 3 of 7 evaluable patients (43%) with confirmed responses at upper expansion dose (10 mg/kg Q3W) - - Median progression free survival of 5.8 months as of April 7th 2025 data cutoff - - Encouraging initial safety profile with no dose limiting toxicities at data cutoff - - Planning Phase 2 study initiation in 1H 2026 - - Conference call on Monday, May 12 at 8:00 a.m. ET - SOUTH SAN FRANCISCO, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced positive interim Phase 1 data for its EpCAM PROBODY® ADC candidate, CX-2051, in advanced, late-line CRC. The data are as of an April 7th 2025 data cutoff from the ongoing CTMX-2051-101 Phase 1 study. “EpCAM is a high potential and broadly expressed cancer target that has been challenging to drug historically due to expression on normal tissues. We believe we have broken important new ground with our data announced today, which show potential for markedly improved outcomes for CRC patients,” said Sean McCarthy, D. Phil, chief executive officer and chairman of CytomX. “CX-2051 is showing impressive, durable anti-tumor activity in late line metastatic CRC, an area of high unmet need and a very difficult tumor to treat. Furthermore, CX-2051 has been generally well tolerated, highlighting the power of CytomX PROBODY® masking technology.” Dr. McCarthy added, “Importantly, we believe these results validate EpCAM as an oncology target and unlock a broad development opportunity for CX-2051 in CRC and potentially many other cancer types where EpCAM is expressed. We are excited to rapidly advance CX-2051 for the benefit of CRC patients and to explore the full potential of this novel ADC.” CX-2051 Phase 1a Interim Data Summary in Advanced, Late-line Colorectal Cancer The CTMX-2051-101 study was initiated in April 2024 with dose escalation proceeding through seven dose levels as of April 2025. 25 advanced metastatic CRC patients were treated with CX-2051 across dose levels 1 through 5 as of the April 7, 2025 data cutoff. CX-2051 was administered on a once every three week schedule (Q3W). The 2.4 mg/kg and 4.8 mg/kg doses were single patient dose escalation cohorts not anticipated to be therapeutically active. At the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, 23 patients were treated in total, 18 of whom were efficacy evaluable, having had at least one post-baseline tumor assessment as of the data cutoff. Patient Characteristics: The 25 patients enrolled in the study across dose levels 1 through 5 had previously received a median of 4 prior lines of therapy and all patients had previously been treated with irinotecan. 64% of patients had liver metastases, 64% had KRAS mutations, and 96% were microsatellite stable. Patients were not preselected based on EpCAM expression levels. Efficacy Results: As of the data cutoff, 18 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W. Overall response rate (ORR): 28% of patients (5/18) achieved confirmed partial RECIST v. 1.1 responses. Overall response rates for currently approved therapies in 3rd line or later CRC are in the low to mid-single digit percentages1. At the 10 mg/kg dose, 3 of 7 evaluable patients (43%) achieved confirmed partial responses. The Disease Control Rate2 was 94% across the three dose groups (17/18). Durability: Median progression free survival was 5.8 months as of the data cutoff. 10 of 18 patients remained on study treatment as of the data of cutoff. 28% of patients (5/18) achieved confirmed partial RECIST v. 1.1 responses. Overall response rates for currently approved therapies in 3rd line or later CRC are in the low to mid-single digit percentages1. At the 10 mg/kg dose, 3 of 7 evaluable patients (43%) achieved confirmed partial responses. The Disease Control Rate2 was 94% across the three dose groups (17/18). Median progression free survival was 5.8 months as of the data cutoff. 10 of 18 patients remained on study treatment as of the data of cutoff. Safety Results: As of the data cutoff, 25 patients were evaluable for safety. CX-2051 was generally well-tolerated with manageable adverse events, with no observed dose limiting toxicities. Most treatment related adverse events (TRAEs) were Grade 1 or Grade 2 in severity. The most common reported TRAEs were diarrhea (18 patients, 5 Grade 3), nausea (11 patients, 1 Grade 3), vomiting (8 patients, No Grade 3), fatigue (8 patients, 1 Grade 3), anemia (5 patients, 3 Grade 3), hypokalemia (3 patients, 1 Grade 3), neutrophil count decrease (2 patients, 2 Grade 3) and neutropenia (2 patients, 1 Grade 3). TRAEs included serious adverse events in 5 patients (1 Grade 2, 4 Grade 3). No Grade 4 or 5 TRAEs were observed. No events of pancreatitis, interstitial lung disease or febrile neutropenia were reported at time of data cutoff. CX-2051 Phase 1 Dose Expansions Initiated: Dose expansions have been initiated at doses of 7.2 mg/kg, 8.6 mg/kg and 10 mg/kg Q3W. A total of 20 patients are expected to be enrolled at each dose level to inform the selection of recommended phase 2 dose. CX-2051 Anticipated Milestones: CX-2051 Monotherapy for Advanced Late-Line CRC: Additional Phase 1 data update by Q1 2026 Planning Phase 2 study initiation in 1H 2026 CX-2051 CRC Combinations: Potential to initiate CX-2051 combination studies in earlier lines of CRC in 2026 CX-2051 Pan-tumor Potential: Evaluate non-CRC, EpCAM-expressing tumor indications for potential Phase 1b study initiation in 2026 Additional Phase 1 data update by Q1 2026 Planning Phase 2 study initiation in 1H 2026 Potential to initiate CX-2051 combination studies in earlier lines of CRC in 2026 Evaluate non-CRC, EpCAM-expressing tumor indications for potential Phase 1b study initiation in 2026 CytomX Investor Event Information Additional details will be provided on the Company’s Investor Call on May 12, 2025 at 8 a.m. EST. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at https://ir.cytomx.com/events-and-presentations. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website for at least 30 days. About CTMX-2051-101 Study Additional information about the CTMX-2051-101 study can be found here on clinicaltrials.gov. About CX-2051 (EpCAM PROBODY® ADC) CX-2051 is an investigational masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM) and armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC, and was discovered in collaboration with ImmunoGen, now part of AbbVie. EpCAM (Epithelial Cell Adhesion Molecule) is a highly expressed but previously undruggable tumor antigen due to expression on normal tissues. CX-2051 is designed to open a therapeutic window for this high potential target and to deliver meaningful anti-cancer activity in solid tumors, including CRC. About CytomX Therapeutics CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY® therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (ADCs), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-2051 and CX-801. CX-2051 is a masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM), armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC. CX-801 is a masked interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter). CytomX Therapeutics Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to CX-2051. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-2051 and CX-801, the potential benefits or applications of CytomX’s PROBODY® therapeutic platform, CytomX’s or its collaborative partners’ ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2051 and CX-801 and the timing of initial and ongoing data availability for our clinical trials, including CX-2051 and CX-801, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel PROBODY® therapeutic technology; uncertainties around the Company’s ability to raise sufficient funds to carry out its planned research and development; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial CX-2051 results, may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-2051 and CX-801; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in the United States and foreign countries, including China and the European Union; and the risk that we may incur higher costs than expected for research and development or unexpected costs and expenses or may not obtain expected savings from our announced restructuring. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on May 12, 2025. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc. All other trademarks are the properties of their respective owners. Company Contact: Chris Ogden SVP, Chief Financial Officer cogden@cytomx.com Investor Contact: Precision AQ (formerly Stern Investor Relations) Stephanie Ascher Stephanie.Ascher@precisionaq.com Media Contact: Redhouse Communications Teri Dahlman teri@redhousecomms.com 1 Lonsurf®, Fruzaqla®, Stivarga® package inserts 2 Disease Control Rate: Patients achieving a best response of stable disease, partial response, or complete response. Source: CytomX Therapeutics Inc.

Clinical ResultPhase 1ADC

08 May 2025

·www.fiercepharma.com

Takeda looks toward 'inflection point' as it eyes new launches to shake off Vyvanse generic impacts

The Japanese drugmaker is looking to embark on a new path for growth as it leaves generics-ridden ADHD med Vyvanse behind. This time last year, Takeda was scrambling to accommodate for rapidly sinking profits from the hasty decline of ADHD mainstay Vyvanse with a 140 billion Japanese yen ($899 million) restructuring campaign. Now, things are looking up for the Japanese drugmaker with several key products keeping it afloat as it looks to unlock a new path to growth with upcoming launches.While six new launches are expected to help weather the storm ahead of biosimilar competition to lead sales driver Entyvio at the end of the decade, three “potentially life-transforming” new treatment options are on track for phase 3 readouts this year, the company said in its 2024 full-year earnings release. Takeda’s fiscal year just wrapped up in March 2025 and began in April 2024.2025’s fiscal year, meanwhile, will be “pivotal” as it invests in launch readiness, which is key for the company’s long-term growth potential despite a flat 2025 outlook, CEO Christophe Weber commented. Rusfertide, a treatment for chronic blood disorder polycythemia vera that Takeda bought from Protagonist Therapeutics for $300 million last year, already delivered a phase 3 win in March. The company expects that the buy will be well worth it with $1 billion to $2 billion in potential peak revenue and previously noted that FDA submissions are expected in 2025. Elsewhere, the first half of the year should see a phase 3 readout for narcolepsy type 1 treatment oveporexton, which is looking at $2 billion to $3 billion in peak sales, while the latter half of the year should have phase 3 data from zasocitinib, a TYK2 inhibitor that could “redefine what is possible” as an oral therapy for psoriasis. That one has the greatest potential revenues with $3 billion to $6 billion.Together, the three make an “inflection point” for the company, said Chief Financial Officer Milano Furuta, who is “excited about our growth trajectory." Takeda is hoping that the boosts to come will help it shake off the ghost of its Vyvanse past, its longtime top-selling ADHD med that succumbed to generic competition in late 2023 after 16 years of market exclusivity. The company described its 2025 outlook (PDF) as the final year of “significant” generic headwind to the med, although it may be worth noting that it said the same last year about its 2024 expectations. Nonetheless, the new launch preparations and an expected 30% sales slide for Vyvanse are anticipated to leave revenue at a “broadly flat” 4.5 trillion yen ($31 billion).That forecast does not reflect the potential impact of pharmaceutical-specific tariffs, Takeda noted, although it will “continue to monitor the situation.” Since 50% of its revenue comes from the U.S. and its imports make up only about 8% to 10% of its total U.S. revenue, the company’s potential exposure to tariffs are “limited,” it explained. The drugmaker is meanwhile taking “mitigation measures” for imports that may be impacted by tariffs, detailing its current global manufacturing network as 22 internal sites with 20 that supply the U.S. and 7 located in the U.S.Takeda did however also make some major cuts across its experimental drug pipeline. This includes the axing of three cancer candidates that has now halved the number of all oncology meds in Takeda’s phase 1 and 2 pipeline.Over 2024, Takeda reported a 7.5% boost in revenue to 4.6 trillion Japanese yen ($31.8 billion), although net profit fell 25.1%. Weber attributed its “multi-year efficacy program” to the company’s 4.9% bump in core operating profit growth. So fair, said program, which was unveiled last year to reduce layers and encourage organizational simplicity, added up to around 200 billion Japanese yen ($1.38 billion) in annualized savings to date and has prompted 3,000 layoffs (PDF) so far.The company’s "growth and launch" collection includes several products across its six key business areas and made up 48% of its total core revenue. Inflammatory bowel disease (IBD) drug Entyvio is Takeda’s top growth driver and is “maintaining share leadership” even as the IBD market becomes more and more crowded with fierce competition from AbbVie's Skyrizi and Rinvoq, among others. Still, the company touts it as the #1 brand in IBD and is bolstered by its newly launched pen option.Other growth drivers include metastatic colorectal cancer (mCRC) treatment Fruzaqla, which grew 351% to 48 billion Japanese yen ($331 million) and is seeing “strong uptake” in the U.S., while dengue vaccine Qdenga is on track to hit 100 million manufactured doses by 2030.

AcquisitionPhase 3Biosimilar

100 Deals associated with Fruquintinib

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KEGG	Wiki	ATC	Drug Bank
D11977	-	L01XE	DB11679

R&D Status

Approved

10 top approved records.

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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
Gastroesophageal junction adenocarcinoma	NDA/BLA	China	Hutchison MediPharma Ltd.	18 Apr 2023
Stomach Cancer	NDA/BLA	China	Hutchison MediPharma Ltd.	18 Apr 2023
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
Metastatic colon cancer	Phase 3	Australia	Hutchison MediPharma Ltd.	12 Aug 2020
Metastatic colon cancer	Phase 3	Austria	Hutchison MediPharma Ltd.	12 Aug 2020
Metastatic colon cancer	Phase 3	Belgium	Hutchison MediPharma Ltd.	12 Aug 2020
Metastatic colon cancer	Phase 3	Czechia	Hutchison MediPharma Ltd.	12 Aug 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


multi-cohort study of treatment regimens for metastatic colorectal cancer (mCRC) (AACR2025)	Not Applicable	Metastatic Colorectal Carcinoma	53	Fruquintinib followed by Regorafenib	cbvueuupag(tihcuydvrz) = otdzufsvmy rzzsftpazi (wabttqgoem )	Negative	28 Apr 2025
	Not Applicable	Metastatic Colorectal Carcinoma	53	Regorafenib followed by Fruquintinib	cbvueuupag(tihcuydvrz) = orttkscaht rzzsftpazi (wabttqgoem )	Negative	28 Apr 2025
NCT04716634 (CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	84	Tislelizumab+Fruquintinib (Gastric Cancer (GC): Tislelizumab and Fruquintinib)	bpeqwqtfaz = wzteaaklfe mappprfntq (dcqaselxaa, mqyugwuhpf - wfpadtaqqo) View more	-	25 Mar 2025
NCT04716634 (CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	84	Tislelizumab+Fruquintinib (Colorectal Cancer (CRC): Tislelizumab and Fruquintinib)	bpeqwqtfaz = uvasrauzmp mappprfntq (dcqaselxaa, vksakscppw - oogwsguozo) View more	-	25 Mar 2025
NCT05522231 (FRUSICA-2, GlobeNewswire) Manual	Phase 2/3	Advanced Renal Cell Carcinoma Second line	-	fruquintinib + sintilimab	hxpavhztgy(bcnstkzrjy) = met its primary endpoint of progression free survival. pprkantfgx (kobvkdejqr ) Met View more	Positive	18 Mar 2025
NCT05971199 (ESMO_TAT2025)	Phase 2	Unresectable Hepatocellular Carcinoma	24	Fruquintinib + Sintilimab + TACE	ujakcomghq(birsgxglpk) = hfzudwbxqa xedrgtvnvm (gwylwwljoj, 5.8 - 21.8) View more	Positive	03 Mar 2025
NCT04322539 (FRESCO-2, Pubmed \| Eur J Cancer)	Phase 3	Metastatic Colorectal Carcinoma	-	Fruquintinib + Best Supportive Care	xkrnjkgbfn(iejfdvuece) = rpzhokirqm ucyurhscdp (vrjhcfdgsw )	Positive	01 Mar 2025
NCT04322539 (FRESCO-2, Pubmed \| Eur J Cancer)	Phase 3	Metastatic Colorectal Carcinoma	-	Placebo + Best Supportive Care	xkrnjkgbfn(iejfdvuece) = zmzwzrtoeu ucyurhscdp (vrjhcfdgsw )	Positive	01 Mar 2025
NCT05831891 (ASCO_GU2025) Manual	Phase 2	Renal Cell Carcinoma First line	16	Fruquintinib+serplulimab	qvvmqfnjcc(ticlkcrfgc) = not reached eqfyrmxuuu (fumdehmbts ) View more	Positive	13 Feb 2025
NCT06158919 (FDZL-FIX, ASCO_GI2025) Manual	Phase 2	HER2 negative Gastroesophageal Junction Adenocarcinoma \| HER2 negative Gastric Cancer First line HER2 Negative	27	Fruquintinib + sintilimab/nivolumabsintilimab/nivolumab + XELOX/SOX	fjvfncxblw(dhwnkfnggi) = izbunmzvjl bkbqlxsysh (psxatvagbg, 5.29 - NA) View more	Positive	23 Jan 2025
NCT05024812 (ASCO_GI2025) Manual	Phase 1/2	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line PD-L1 Negative \| PD-L1 Low Expression	30	Fruquintinib + toripalimab + oxaliplatin + S-1	pqjvzkygkd(bqwllzrdjc) = utozkhiizn iewoaecibs (vbikmdrjfk, 5.68 - NA) View more	Positive	23 Jan 2025
NCT05024812 (ASCO_GI2025) Manual	Phase 1/2		30	Fruquintinib + toripalimab + oxaliplatin + S-1 (Pts with CPS < 5)	kqrzpicxdu(sutatnoowg) = dwamgvpfnf pcxewoaila (wuftyjhqmx )	Positive	23 Jan 2025
NCT06010212 (ASCO_GI2025) Manual	Phase 2	Advanced Esophageal Squamous Cell Carcinoma First line	11	Fruquintinib + camrelizumab +paclitaxel liposome + nedaplatin	hriieknkvd(wkajfyiugg) = pqheviujog jxninuqxed (creywlycld, 42.1 - 99.6) View more	Positive	23 Jan 2025
NCT05659290 (ASCO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma Maintenance	40	Fruquintinib 5mg	wvtkcmcrne(kkhzwaxlfy) = duynvaymzl woojlcxmcg (cbqtibjnkb ) View more	Positive	23 Jan 2025

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