CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), VEGFR antagonists(Vascular endothelial growth factor receptor antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [6]

Active Indication

Advanced Pancreatic Neuroendocrine TumorNeuroendocrine CarcinomaSolid tumor+ [25]

Inactive Indication

Advanced Thyroid Gland CarcinomaAdvanced Thyroid Gland Medullary CarcinomaIslet Cell Adenoma+ [5]

Originator Organization

Hutchison MediPharma Ltd.

Active Organization

HUTCHMED (China) Ltd.

Hutchison MediPharma Ltd.

BeiGene Ltd.

+ [1]

Inactive Organization

Innovent Biologics (Suzhou) Co. Ltd.

Innovent Biologics, Inc.

Drug Highest PhaseApproved

First Approval Date

CN (18 Jun 2021),

Advanced Pancreatic Neuroendocrine Tumor

RegulationOrphan Drug (US), Priority Review (CN), Fast Track (US)

Structure

Molecular FormulaC24H28N6O3S

InChIKeyTTZSNFLLYPYKIL-UHFFFAOYSA-N

CAS Registry1308672-74-3

130

Clinical Trials associated with Surufatinib

NCT06654947 / Not yet recruitingPhase 2IIT

A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.

This is a single-arm, open-label, prospective clinical study aimed at observing and evaluating the efficacy and safety of surufatinib combined with immunotherapy and chemotherapy in the treatment of unresectable or metastatic biliary tract cancer.

Start Date01 Jan 2025

Sponsor / Collaborator

Fujian Cancer Hospital

NCT06656559 / Not yet recruitingPhase 2IIT

Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma: A Prospective, Single-Arm, Single-Center Phase II Clinical Study

The sequential treatment strategy of ERCP-RFA combined with envafolimab and surufatinib proposed in this study aims to maximally inhibit the progression of unresectable biliary tract tumors through the combined application of multiple therapeutic modalities. ERCP-RFA, as a local treatment, first reduces the tumor burden and alleviates biliary obstruction through physical ablation. Subsequently, Envafolimab enables the body to more effectively identify and attack the remaining tumor cells by activating the immune system. Finally, Surufatinib as a targeted drug, further controls the growth and spread of tumors by inhibiting tumor angiogenesis and cell proliferation. The potential advantage of this combined treatment lies in the complementary effects of different therapeutic modalities.

Start Date01 Oct 2024

Sponsor / Collaborator

Tianjin Cancer Institute

NCT06531291 / Not yet recruitingPhase 2IIT

Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study

Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

Start Date10 Aug 2024

Sponsor / Collaborator

Shanghai Renji Hospital

100 Clinical Results associated with Surufatinib

100 Translational Medicine associated with Surufatinib

100 Patents (Medical) associated with Surufatinib

Literatures (Medical) associated with Surufatinib

23 Oct 2024·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[Chinese multidisciplinary expert consensus on the rational use of surufatinib in clinical practice（2024 edition）].

Article

Neuroendocrine neoplasms are a group of heterogeneous tumors originating from the neuroendocrine system, which can occur in any part of the body. Pulmonary and gastroenteropancreatic neuroendocrine tumors are the most common. In recent years, the global incidence of neuroendocrine tumors has increased more significantly than other types of tumors, especially in the past 40 years. The drug treatment of neuroendocrine tumors includes somatostatin analogues, anti-angiogenesis targeting drugs, nuclide therapy and chemotherapy. Surufatinib is an oral tyrosine kinase receptor inhibitors that targets for vascular endothelial growth factor receptor (VEGFR1-3), fibroblast growth factor receptor 1 (FGFR1), and colony-stimulating factor-1 receptor (CSF-1R), has received approval in 2020 and 2021 for the treatment of locally advanced or metastatic, progressive nonfunctional, well-differentiated (G1, G2) neuroendocrine tumors (NETs) of both pancreatic and extrapancreatic origin that are unresectable. Ongoing exploratory studies are investigating its potential application in other tumor types. Common adverse reactions observed during surufatinib treatment include hypertension, proteinuria, bleeding events, and hepatic lab test abnormal and diarrhea. Chinese multidisciplinary expert consensus on the rational use of surufatinib in clinical practice (2024 edition) aims to provide standardized guidance for its rational use and enhance patient compliance to maximize therapeutic benefits.

01 Sep 2024·Heliyon

Efficacy of surufatinib in the treatment of advanced parathyroid carcinoma: A case report

Article

Author: Xie, Xiaojun ; Zhou, Jie ; Li, Xuan ; Wang, Junli ; Chen, Linghui ; Yu, Zhiyong ; Hu, Liang ; Wu, Yijun ; Zhang, Qijun ; Li, Fuqiang

Parathyroid cancer is an extremely rare form of neuroendocrine malignancy. Apart from surgery, the effectiveness of chemotherapy and radiotherapy is limited, and the efficacy of targeted drugs remains unclear. In this study, we demonstrate the therapeutic effectiveness and adverse reaction of the targeted drug surufatinib in treating a case of parathyroid cancer, and concurrently review the recent advancements in the treatment of parathyroid cancer. The patient, a 55-year-old male, underwent his first surgery for a "right cervical mass" in May 2011. Postoperative pathology indicated an atypical adenoma of the parathyroid gland. In August 2016, the patient underwent a second surgery for recurrence of the right cervical tumor, with a pathological diagnosis of parathyroid cancer based on clinical history. In November 2017, the patient underwent a third surgery for recurrence of the right cervical tumor. In December 2017, the patient underwent adjuvant external radiation therapy. In August 2022, the patient developed spinal and lung metastases and underwent spinal surgery. Subsequently, the patient received three rounds of chemotherapy on October 5, 2022, October 28, 2022, and November 18, 2022, but the tumor showed slight enlargement. In January 2023, the patient began treatment with surufatinib. After two cycles of treatment, the tumor showed regression. Given the scarcity of systemic treatment options for parathyroid cancer, the targeted drug surufatinib may offer a promising potential treatment option.

01 Apr 2024·Cancer medicine

Surufatinib combined with transarterial embolization versus surufatinib monotherapy in patients with liver metastatic neuroendocrine tumors: Study protocol for a prospective, randomized, controlled trial

Article

Author: Li, Ruizhen ; Su, Minggang ; Ke, Nengwen ; Cao, Dan ; Li, Xiaofen ; Liu, Yuzhi ; You, Xin

Abstract:

Background:

More than half of neuroendocrine tumor (NET) patients will experience liver metastasis, and interventional therapy represented by transarterial embolization (TAE) is the main local treatment method. Surufatinib is recommended as a standard systemic treatment for advanced NETs. The efficacy and safety of surufatinib combined with TAE in the treatment of liver metastasis are undetermined. This study was conducted to compare the clinical outcome of surufatinib combined with TAE versus surufatinib monotherapy in liver metastatic NETs.

Methods:

This is a prospective, multicenter, open‐label, and randomized controlled trial. Patients diagnosed with liver metastatic NETs will be enrolled. Participants are randomly assigned in a 1:1 ratio to either the experimental group or the control group. Patients will be treated with surufatinib plus TAE in the experimental group, while patients in the control group will receive surufatinib monotherapy. The primary endpoint is progression‐free survival (PFS) assessed by a blinded independent image review committee (BIIRC). The secondary endpoints are investigator‐assessed PFS, liver‐specific objective response rate (ORR), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and incidence of adverse events.

Discussion:

This is the first prospective study to investigate the efficacy of surufatinib combined with TAE. We expect this trial to propose a new and effective treatment strategy for liver metastatic NETs.

News (Medical) associated with Surufatinib

16 Sep 2024

·endpts.com

FDA tells oncology companies how to run multi-regional cancer trials with a US approval in mind

The FDA on Monday released new draft guidance on conducting multi-regional oncology trials, saying its “paramount consideration” is whether the results apply to the intended use population and standard cancer care practices in the US. The draft’s release coincides with the European Society for Medical Oncology’s conference in Barcelona this week, and it comes more than two years after the FDA shut the door on companies only relying on data from China-based trials for new cancer drug approvals. Back in 2022, the regulator issued a complete response letter to Eli Lilly and Innovent’s sintilimab regarding its China-only data. The agency similarly rejected Hutchmed’s surufatinib, a kinase inhibitor that blocks VEGFR and FGFR, as a treatment of pancreatic and extrapancreatic neuroendocrine tumors, citing similar concerns. While the FDA’s new nine-page draft doesn’t specifically mention China, it notes that there has been a “decreasing proportion of US participants” in cancer drug trials. If a sponsor is planning a multi-regional trial to support a new drug approval, the FDA recommends “that such a trial be conducted across major geographical regions (e.g., across several continents) rather than predominantly in a single country or in a single geographical region (e.g., Asia).” The guidance said sponsors should be aware that if a trial’s participant demographics differ significantly from the US population, “foreign data may not be appropriate to support an FDA regulatory decision.” However, the agency also said there are some circumstances in which it may be acceptable for a sponsor to conduct a multi-regional trial. That includes enrolling “a substantial proportion of participants in a single foreign geographical region if such a trial is conducted as part of an overall program that includes one or more additional pivotal trials in the premarket setting that will enroll a population that is representative of the US population.” For trials of drugs intended to treat cancers that are common in the US like colorectal or breast cancer, the FDA recommends “equal allocation of study participants across the selected major geographical regions, including North America.” Equal allocation is defined as using equal numbers of subjects from each region. And for studies in cancers that occur “much less commonly in the US compared to regions outside the US (e.g., squamous cell esophageal cancer), FDA recommends a proportional allocation approach.” Proportional allocation is defined by the draft as the allocation of subjects to regions in proportion to the size of the region and disease prevalence. The FDA also said companies should take into account patient-related factors like disease risk and genetic background in addition to disease-related and socio-cultural factors, including diet, when deciding if a multi-regional trial is appropriate. Sponsors should request a meeting with the regulator if and when the treatment landscape changes during a trial to determine the most efficient approach to incorporating those changes into an ongoing trial.

Clinical Study

16 Sep 2024

·endpts.com

Exelixis’ drug staves off neuroendocrine tumor progression in broad swath of patients

BARCELONA — A new treatment option for a wide range of patients diagnosed with neuroendocrine tumors could be approved in April, as final results of a Phase 3 study on Exelixis’ cabozantinib were presented Monday at the European Society for Medical Oncology. The CABINET study included two cohorts of people with neuroendocrine tumors depending on the tumor location — in the pancreas or outside of it. In 203 patients with extrapancreatic neuroendocrine tumors, cabozantinib lowered the risk of disease progression or death by 62% compared to placebo. In a smaller cohort of 95 patients with pancreatic tumors, Exelixis’ drug cut the risk of disease progression or death by 77%. The study had been stopped early at an interim analysis because of its compelling efficacy findings versus placebo. The trial investigators noted that the early termination of the study “could potentially lead to overestimation of the treatment effect,” though they added the progression-free survival analyses in both cohorts were “relatively mature,” according to a concurrent publication of the results in the New England Journal of Medicine . Exelixis markets cabozantinib as Cabometyx and Cometriq, and last year the company generated $1.8 billion in sales from the tyrosine kinase inhibitor. The drug is approved for kidney cancer, liver cancer and thyroid cancer, and is awaiting an FDA decision in neuroendocrine tumors by April 3 . Neuroendocrine tumors can occur anywhere in the body, meaning existing treatment options vary from patient to patient. Treatment options include somatostatin analogues like octreotide, everolimus, Novartis’ radiopharmaceutical Lutathera, chemotherapy, and the targeted therapy sunitinib — but what’s available to patients depends on their tumor. For example, Lutathera is approved for patients with a certain level of somatostatin receptor expression, while sunitinib is used in patients with pancreatic neuroendocrine tumors only. Gastrointestinal oncologist James Yao from the University of Texas MD Anderson Cancer Center told Endpoints News on the sidelines of the confab that for lung neuroendocrine tumor patients, this approval could be especially impactful because the only current go-to option for them is everolimus. Patients were enrolled in Exelixis’ study regardless of where their primary tumor was, though they were required to have tried at least one previous therapy. The median number of previous treatments was two or three across the study cohorts. “We were looking at a very broad group of patients … and we saw efficacy across the board,” Dana-Farber Cancer Institute neuroendocrine tumor specialist Jennifer Chan said. “This opens up options for a large number of patients. It’s not limited to just a small subset of patients.” Chan, the principal investigator on the study, spoke to Endpoints ahead of her Monday presentation. Yao noted that in China, the tyrosine kinase inhibitor surufatinib is approved for both pancreatic and extrapancreatic neuroendocrine tumors. The drug, developed by Hutchmed, was rejected in the US by the FDA in 2022 as its pivotal clinical trials were run in China. In Exelixis’ Phase 3 study, the median progression-free survival was 8.4 months on cabozantinib compared to 3.9 months on placebo in extrapancreatic tumors. In pancreatic neuroendocrine tumors, the median progression-free survival was 13.8 months compared to 4.4 months for placebo, with p<0.001 in both groups. Also, the response rate was 5% and 19% in extrapancreatic and pancreatic neuroendocrine tumors, respectively, versus 0% with placebo. The most common severe treatment-related adverse events were hypertension, fatigue, diarrhea, and thromboembolic events. Around two-thirds of patients in both the extrapancreatic and pancreatic groups on cabozantinib required dose reductions of the drug, and 31% and 20% of patients in the respective groups discontinued treatment due to adverse events. Exelixis’ medical chief Amy Peterson said that because cabozantinib is already approved in liver cancer, gastrointestinal oncologists are already familiar with the drug. They’re also familiar with the toxicities and dose reductions needed for sunitinib, which is also a VEGF tyrosine kinase inhibitor. In August, Exelixis announced that Cabometyx in combination with Tecentriq did not improve survival in a pivotal prostate cancer trial called CONTACT-02, details of which were shared at ESMO as well. Exelixis’ partner Ipsen, which has rights to Cabometyx outside of the US and Japan, announced Sunday that it does not plan to seek regulatory approvals based on the study. Exelixis confirmed to Endpoints that it still plans to file for approval based on the prostate cancer study this year.

Phase 3Drug ApprovalClinical Result

09 Sep 2024

·www.globenewswire.com

HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2024 and the 2024 World Conference of Lung Cancer

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 09, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2024 World Conference on Lung Cancer (“WCLC24”) in San Diego, USA, and the European Society for Medical Oncology (“ESMO”) Congress 2024, taking place in Barcelona, Spain. Results from the FLOWERS study, a prospective, two-arm, randomized, multicenter Phase II clinical trial of osimertinib with or without savolitinib as first-line treatment in EGFRm, MET-aberrant advanced non-small cell lung cancer (“NSCLC”) patients, will be presented at WCLC24. As of May 28, 2024, the median follow-up was 8.2 months. Patients treated with osimertinib plus savolitinib (Cohort 2, N=21) showed deeper and more durable response over osimertinib monotherapy (Cohort 1, N=23) along the study follow-up. The confirmed objective response rate (ORR) in Cohort 1 and Cohort 2 were 60.9% and 90.5%, respectively, with disease control rate (DCR) of 87% and 95.2%, respectively. Immature progression-free survival (“PFS”) data also showed a positive trend in favor of the combination therapy, with median PFS of 9.3 months and 19.6 months in the cohort 1 and cohort 2 with maturity of 34.8% and 23.8%, respectively. Safety profiles of osimertinib monotherapy and osimertinib plus savolitinib were as expected, tolerable and manageable. Abstract titlePresenter / Lead authorPresentation detailsWCLC24 - INVESTIGATOR-INITIATED STUDIES Osimertinib with or without savolitinib as 1L in de novo MET aberrant, EGFRm advanced NSCLC (CTONG 2008): A Phase II trialJinji Yang, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Southern Medical University, Guangzhou, ChinaPL04.10Plenary Session PL04 Presidential Symposium 2, Plenary HallMonday, September 9, 2024 at 8:30 AM PDTStudy of Surufatinib Combined with Low Dose Topotecan in Second or Third-Line Multiple Distant Organ Metastatic ES-SCLCYingying Du, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Hesheng Qian, Fuyang Cancer Hospital, Fuyang, ChinaEP.13A.04AePosterSaturday, September 7, 2024Surufatinib Plus Docetaxel in Patients with Relapsed Advanced Driver-Negative Non-Squamous NSCLC: A Phase Ib/II Study Qitao Yu, Wei Jiang, Guangxi Medical University Cancer Hospital, Nanning, ChinaP3.12C.08PosterMonday, September 9, 2024 at 8:30 AM PDT Further analysis of fruquintinib’s FRESCO-2 study in metastatic colorectal cancer and FRUTIGA study in gastric cancer, a biomarker study of savolitinib in gastric cancer as well as investigator-initiated studies of fruquintinib and surufatinib will be presented at the ESMO Congress 2024. Details of the presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsESMO 2024 - SPONSORED STUDIESEfficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer with and without liver metastasis: A subgroup analysis of the phase 3 FRESCO-2 trialRocio Garcia-Carbonero,Hospital Universitario 12 de Octubre, lmas12, UCM, Madrid, Spain520P Poster Session – Colorectal cancerMonday, 16 September 2024Efficacy and safety of fruquintinib in refractory metastatic colorectal cancer: A FRESCO-2 subgroup analysis by ageMaria Elena Elez Fernandez,Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain526PPoster Session – Colorectal cancerMonday, 16 September 2024Efficacy of fruquintinib plus paclitaxel (F+PTX) in patients (pts) with prior immunotherapy (prior-IO): subgroup analysis from FRUTIGA studyLin Shen,Peking University Cancer Hospital & Institute, Beijing, China1410PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Impact of subsequent anti-tumor therapies in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma receiving fruquintinib (F) plus paclitaxel (PTX) or placebo plus PTX in FRUTIGA studyRuihua Xu,Sun Yat-sen University Cancer Center, Guangzhou, China1434PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Association between Fruquintinib-induced Hypertension and Clinical Outcomes from FRUTIGA, a Phase 3 Study of Fruquintinib plus Paclitaxel in Previously Treated Advanced Gastric or Gastroesophageal Junction (G/GEJ) AdenocarcinomaShukui Qin,Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Nanjing, China1443PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Analysis of MET gene alterations in cfDNA samples from a phase II study of savolitinib in patients (pts) with MET-amplified gastroesophageal junction adenocarcinomas or gastric cancer (GEJ/GC)Zhi Peng,Peking University Cancer Hospital & Institute, Beijing, China1461PPoster Session – Oesophagogastric cancerMonday, 16 September 2024 ESMO 2024 - INVESTIGATOR-INITIATED STUDIES A phase II clinical study of fruquintinib (Fru) combined with toripalimab (Tor) and short-course radiotherapy (SCRT) as neoadjuvant therapy for locally advanced rectal cancer (LARC)Zhiping Li, Ye Chen,West China Hospital of Sichuan University, Chengdu, China570PPoster Session – Colorectal cancerMonday, 16 September 2024Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: Updated findings from a single-arm, prospective phase II trial (RIFLE)Zhen Zhang, Yajie Chen, Fudan University Shanghai Cancer Center, Shanghai, China537P Poster Session – Colorectal cancerMonday, 16 September 2024Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated resultsYongqian Shu, Pei Ma,Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical University, Nanjing, China1329P Poster Session – NSCLC, metastaticSaturday, 14 September 2024Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION)Xiaobing Chen, Beibei Chen,Henan Cancer Hospital/ Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China1475TiPPoster Session – Oesophagogastric cancerMonday, 16 September 2024Fruquintinib combined with nab-paclitaxel and gemcitabine (AG) as the first-line treatment for pancreatic ductal adenocarcinoma (PDAC) with liver metastases: An open-label, single-arm, single-center phase II clinical studyXianjun Yu, Miaoyan Wei,Fudan University Shanghai Cancer Center, Shanghai, China1529P Poster Session – Pancreatic cancerMonday, 16 September 2024A phase II study of Fruquintinib in the 1L or 2L treatment of unresectable metastatic soft tissue sarcomaZhiguo Luo, Xiaowei Zhang,Fudan University Shanghai Cancer Center, Shanghai, China1743PPoster Session – SarcomaSaturday, 14 September 2024Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II studyFuxiang Zhou,Zhongnan Hospital, Wuhan University, Wuhan, China974PPoster Session – Hepatocellular carcinoma (HCC)Monday, 16 September 2024Updated results of Surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trialDan Cao, West China Hospital, Sichuan University, Chengdu, China1155PPoster Session – Neuroendocrine tumoursMonday, 16 September 2024Surufatinib plus toripalimab combined with pemetrexed (A), and platinum (P) in patients (pts) with advanced non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results of a single-center, phase II trialLi Zhang, Wenfeng Fang,Sun Yat-Sen University Cancer Center, Guangzhou, China1345PPoster Session – NSCLC, metastaticSaturday, 14 September 2024Surufatinib combined with gemcitabine in soft tissue sarcoma (STS) patients failed with anthracyclines chemotherapy or monotherapy post-anlotinib progression: a multi-center, phase II trialXiaohui Niu, Yuhong Zhou,Zhongshan Hospital, Fudan University, Shanghai, China1740PPoster Session – SarcomaSaturday, 14 September 2024 About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer 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 marketed in the US and Europe. 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 but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib and surufatinib, the further clinical development for fruquintinib, savolitinib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib 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 fruquintinib, savolitinib 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 fruquintinib, savolitinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of CAPEOX, docetaxel, gemcitabine, nab-paclitaxel, paclitaxel, pemetrexed, platinum, sintilimab, topotecan, tislelizumab or toripalimab 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 U.S. 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 Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley /Rupert Dearden, Panmure Liberum+44 (20) 7886 2500

Phase 2Clinical ResultImmunotherapy

100 Deals associated with Surufatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11885	-	L01XX	DB15106

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Pancreatic Neuroendocrine Tumor	CN	Hutchison MediPharma Ltd.	18 Jun 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neuroendocrine Carcinoma	NDA/BLA	US	HUTCHMED (China) Ltd.	17 Aug 2022
Neuroendocrine Carcinoma	NDA/BLA	CN	HUTCHMED (China) Ltd.	17 Aug 2022
Neuroendocrine Carcinoma	NDA/BLA	EU	HUTCHMED (China) Ltd.	17 Aug 2022
Neuroendocrine Carcinoma	NDA/BLA	JP	HUTCHMED (China) Ltd.	17 Aug 2022
Solid tumor	NDA/BLA	US	HUTCHMED (China) Ltd.	17 Aug 2022
Solid tumor	NDA/BLA	EU	HUTCHMED (China) Ltd.	17 Aug 2022
Islet Cell Adenoma	NDA/BLA	CN	Hutchison MediPharma Ltd.	13 Nov 2019
Pancreatic Ductal Adenocarcinoma	Phase 3	CN	HUTCHMED (China) Ltd.	14 May 2024
Secondary malignant neoplasm of pancreas	Phase 3	CN	HUTCHMED (China) Ltd.	08 May 2024
Advanced Neuroendocrine Carcinoma	Phase 3	CN	Hutchison MediPharma Ltd.	09 Sep 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05282433 (ESMO2024) Manual	Phase 2	Advanced Hepatocellular Carcinoma Third line \| Second line	24	Surufatinib + anti-PD-1/PD-L1 antibody	gvvndxfhle(aisamfnbpo) = icigjlgcaz pxohnvaosn (rcmirgvnba ) View more	Positive	16 Sep 2024
				Surufatinib	gvvndxfhle(aisamfnbpo) = sbdbjyzhep pxohnvaosn (rcmirgvnba ) View more
ChiCTR2300071991 (ESMO2024) Manual	Phase 3	Neuroendocrine Tumors	29	Surufatinib + TAE	svfurpzkkr(ghhpwngdsz) = not mature jtkzjuvlif (ajgrdpvedt ) View more	Positive	16 Sep 2024
				Surufatinib
ChiCTR2100053490 (ESMO2024) Manual	Phase 2	Soft Tissue Sarcoma	25	Surufatinib + Gemcitabine (STS failed to first-line anthracyclines chemotherapy)	zivtbnnxlh(qmijrsvyzv) = bpiubzczii aibhndzpfo (amcrzlqbpf ) View more	Positive	14 Sep 2024
				Surufatinib (failed with anlotinib)	zivtbnnxlh(qmijrsvyzv) = ttrbahaqdo aibhndzpfo (amcrzlqbpf ) View more
NCT05003037 (ESMO2024) Manual	Phase 2	Non-squamous non-small cell lung cancer Second line \| First line	74	Surufatinib+toripalimab+pemetrexed+patinum (Naive advanced nsq-NSCLC pts without driver gene mutation)	wnjjgkpeik(hakryabvyw) = xaekpsvzzk aaqugxgyql (sgexyrtizh, 3.5 - 17.3) View more	Positive	14 Sep 2024
				Surufatinib+toripalimab+pemetrexed+patinum (driver gene mutations failing with tyrosine kinase inhibitors)	wnjjgkpeik(hakryabvyw) = ztulyfpfas aaqugxgyql (sgexyrtizh, 6.6 - 13.7) View more
NCT02549937 (CTgov)	Phase 1/2	Advanced Malignant Solid Neoplasm	130	Surufatinib (Dose-Escalation Phase: Surufatinib 50 mg)	wqbacmgqir(jsdaitjpfp) = gjlzpvvdfx eqnxskdmac (fbqsfpkbbs, jzaqswwnha - ruhnnclfho) View more	-	10 Jul 2024
				Surufatinib (Dose-Escalation Phase: Surufatinib 100 mg)	wqbacmgqir(jsdaitjpfp) = ferpkaccdy eqnxskdmac (fbqsfpkbbs, lusixyqnut - wiskysketh) View more
NCT04734249 (ESMO_GI2024) Manual	Phase 2	Metastatic Colorectal Carcinoma	56	Surufatinib plus mFOLFOX6/FOLFIRI	ocapzrjhuf(ixeahytqcf) = iuseygrwdh pfykuzjpfh (mvnyunhmpa ) View more	Positive	27 Jun 2024
				Surufatinib plus FOLFOXIRI	ocapzrjhuf(ixeahytqcf) = tbqntlfzgo pfykuzjpfh (mvnyunhmpa ) View more
NCT04734249 (ESMO_GI2024) Manual	Phase 2	Metastatic Colorectal Carcinoma Second line	29	Surufatinib+mFOLFOX6/FOLFIRI	nvuhsegvcq(zenecdlvqs) = gxgcztuayr yekjrowmof (yssnngyggv ) View more	Positive	20 Jun 2024
				Surufatinib+FOLFOXIRI	nvuhsegvcq(zenecdlvqs) = wavumaxerz yekjrowmof (yssnngyggv ) View more
NCT05509699 (ASCO2024) Manual	Phase 2	Extensive stage Small Cell Lung Cancer First line \| Maintenance	21	Surufatinib + PD-1/L1 inhibitors	yoysazsnec(kyfasadylc) = asocivyiwl lxqumfoktk (krlxhsqtmf, 2.0 - 5.6) View more	Positive	24 May 2024
NCT04922658 (ASCO2024) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma Third line	44	Surufatinib+Vinorelbine (cohort 1)	uhxaqzmrmf(cqixxdehis) = zqilmndnzm yuykzmowri (htibnrtpbd ) View more	Positive	24 May 2024
				Surufatinib (cohort 2)	uhxaqzmrmf(cqixxdehis) = soqdbdavsj yuykzmowri (htibnrtpbd ) View more
NCT04929652 (ASCO2024) Manual	Phase 1/2	Advanced Colorectal Adenocarcinoma Second line BRAF Mutation \| KRAS Mutation \| NRAS Mutation	30	Surufatinib+camrelizumab+irinotecan+GM-CSF	cpnigmtdtj(cmcgicqwzy) = nciqerxbui hxzdkauznt (ewphwyuwse, 14.7 - 49.4) View more	Positive	24 May 2024
				Surufatinib+camrelizumab+irinotecan+GM-CSF (RAS/BRAF mutations)	cpnigmtdtj(cmcgicqwzy) = xnxndbfsqs hxzdkauznt (ewphwyuwse ) View more

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