Surufatinib

Phase 3Small molecule

Surufatinib is used to treat certain types of cancer, specifically pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors. It works by blocking proteins that help cancer cells grow and survive.[1] Surufatinib is currently being investigated across 18 indications[3], with its most advanced program in Phase 3.[1]

Surufatinib is one of 331 small molecule programs targeting Salivary Gland Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

330

Competitors

Pipeline

Status by Indication[3][1]

Indication

Salivary Gland CancerActive, not recruiting

Lung CancerNot yet recruiting

Pancreatic Neuroendocrine TumorCompleted

Intrahepatic CholangiocarcinomaActive, not recruiting

Biliary Tract CancerRecruiting

Appendix CarcinomaRecruiting

Neuroendocrine NeoplasmRecruiting

Non-Small Cell Lung CancerRecruiting

Pancreatic CancerActive, not recruiting

Gastric CancerActive, not recruiting

Salivary Gland CancerPreclinical

Active, not recruiting

Lung CancerPhase 2

Not yet recruiting

Pancreatic Neuroendocrine TumorPhase 3

Completed

Intrahepatic CholangiocarcinomaPhase 2

Active, not recruiting

Biliary Tract CancerPhase 2

Recruiting

Appendix CarcinomaPhase 2

Recruiting

Neuroendocrine NeoplasmPhase 3

Recruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Pancreatic CancerPhase 2

Active, not recruiting

Gastric CancerPhase 2

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Albumin-Bound Paclitaxel

Bristol-Myers Squibb

Phase 3

2 2

KN046

JJiangsu Alphamab Biopharmaceuticals Co., Ltd

Phase 3

4 3

Surufatinib

HHutchison Medipharma Limited

Phase 3

1 4

Uliledlimab

TTJ Biopharma Co., Ltd.

Phase 3

2 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Pancreatic Neuroendocrine Tumor

NCT06158516

Phase 2Active, not recruiting

Pancreatic Cancer

NCT05481476

Phase 2Active, not recruiting

Advanced Non-Small Cell Lung Cancer

NCT04922658

Q2 2027

Phase 2Not yet recruiting

Lung Cancer

NCT06414915

Q3 2027

Phase 2Recruiting

Biliary Tract Cancer

NCT06708858

Phase 2Not yet recruiting

Advanced Solid Tumors With Neuroendocrine Differentiation

NCT06531291

Clinical

Trials by Indication[1]

Surufatinib6 trials

A Study to Assess the Effect of a Strong CYP3A Inhibitor, on Surufatinib in Healthy Subjects

Completed·HHutchison Medipharma Limited·Phase 1·NCT04372407·13 enrolled

Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)

Recruiting·PPeking University·Phase 2·NCT05165407·30 enrolled

A Study to Assess the Effect of a High Fat Meal on Surufatinib in Healthy Subjects

Completed·HHutchison Medipharma Limited·Phase 1·NCT04372394·28 enrolled

Show 3 more trials

Expanded Access Program of Surufatinib

No longer available·HHutchmed··NCT04814732

Open-Label Surufatinib in European Patients With NET

Terminated·HHutchmed·Phase 2·NCT04579679·78 enrolled

Open-label Study of Surufatinib in Japanese Patients

Completed·HHutchmed·Phase 1/2·NCT05077384·36 enrolled

Pancreatic Cancer4 trials

Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07469956·30 enrolled

Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic Cancer

Unknown status·SShanghai Zhongshan Hospital·Phase 1/2·NCT05832892·41 enrolled

Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer

Active, not recruiting·SSun Yat-sen University·Phase 2·NCT05481476·32 enrolled

Show 1 more trial

Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer

Completed·SSun Yat-sen University·Phase 2·NCT05481463·22 enrolled

Soft Tissue Sarcoma3 trials

The Combination of Radiotherapy，Surufatinib and Sintilimab in High-Risk Localized Soft Tissue Sarcoma

Recruiting·FFudan University·Phase 1/2·NCT05839275·52 enrolled

Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma

Unknown status·SSun Yat-sen University·Phase 2·NCT05106777·47 enrolled

A Study of Surufatinib in the Treatment of Advanced Soft Tissue Sarcoma

Unknown status·FFudan University·N/A·NCT06110650·29 enrolled

Biliary Tract Cancer3 trials

Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer

Recruiting·DDai, Guanghai·Phase 2·NCT06708858·35 enrolled

Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

Unknown status·—·Phase 1/2·NCT06255262·30 enrolled

Combination Therapy of HAIC, Surufatinib and Tislelizumab for Unresectable or Metastatic Biliary Tract Cancer

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT06134193·41 enrolled

Biliary Tract Carcinoma3 trials

A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma

Unknown status·QQilu Hospital of Shandong University··NCT05064852·200 enrolled

Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma

Completed·HHutchison Medipharma Limited·Phase 2·NCT02966821·39 enrolled

A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients

Unknown status·HHutchison Medipharma Limited·Phase 2/3·NCT03873532·298 enrolled

29 more indications

Pancreatic Neuroendocrine Tumor3 trials

A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

Not yet recruiting·—·Phase 2·NCT06158516·100 enrolled

Phase III Study of Surufatinib in Treating Advanced Pancreatic Neuroendocrine Tumors

Completed·HHutchison Medipharma Limited·Phase 3·NCT02589821·195 enrolled

Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors

Completed·HHutchison Medipharma Limited·Phase 3·NCT02588170·219 enrolled

Chemotherapy2 trials

Surufatinib, Toripalimab and Chemotherapy in Second-line MT and MSS CRC

Unknown status·ZZhejiang University·Phase 2·NCT04653480·61 enrolled

Second-line Surufatinib Combined With Chemotherapy in Advanced CRC

Unknown status·FFujian Cancer Hospital·Phase 2·NCT04734249·56 enrolled

Hepatocellular Carcinoma2 trials

Surufatinib Alone or Combined With Anti-PD-1 mAb in the Treatment of Advanced Hepatocellular Carcinoma

Unknown status·ZZhongnan Hospital·Phase 2·NCT05282433·45 enrolled

Surufatinib in Advanced Hepatocellular Carcinoma Based on Single-cell Sequencing of Tumor Samples

Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05171439·6 enrolled

Patients With Advanced Solid Tumors2 trials

Study of Surufatinib Single Agent or Surufatinib Combined With Toripalimab in Patients With Advanced Solid Tumors

Completed·HHutchison Medipharma Limited·Phase 2·NCT04169672·248 enrolled

A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors

Completed·HHutchmed·Phase 1/2·NCT02549937·130 enrolled

Small Cell Lung Cancer2 trials

Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

Completed·HHutchison Medipharma Limited·Phase 2·NCT05509699·21 enrolled

Surufatinib Combined With Irinotecan as a Second-line Treatment for Small Cell Lung Cancer

Unknown status·FFujian Cancer Hospital·Phase 2·NCT05595889·40 enrolled

Neuroendocrine Tumors2 trials

Surufatinib in G3 Neuroendocrine Tumors

Unknown status·QQilu Hospital of Shandong University··NCT05973968·32 enrolled

Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT07279532·35 enrolled

Ovarian Cancer2 trials

Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer

Completed·SSun Yat-sen University·Phase 1/2·NCT05494580·29 enrolled

An Exploratory Clinical Study of Neoadjuvant Therapy With Pamiparib Combined With Surufatinib for Advanced Ovarian Cancer: A Single-arm, Prospective, Single-center Clinical Study

Recruiting·BBai-Rong Xia·Phase 2·NCT05652283·37 enrolled

Thyroid Cancer2 trials

Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer

Recruiting·FFudan University·Phase 2·NCT05989425·32 enrolled

Toripalimab Combined With Surufatinib for Locally Advanced Thyroid Cancer: a Phase II Study

Unknown status·FFudan University·Phase 2·NCT04524884·10 enrolled

Advanced Solid Tumors1 trial

Study of Surufatinib Combined With Sintilimab and SCRT in Advanced Solid Tumors

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT05527821·36 enrolled

Neuroendocrine Neoplasm1 trial

Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms

Recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT07272512·350 enrolled

Non-Small Cell Lung Cancer1 trial

Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer

Recruiting·SSun Yat-sen University·Phase 2·NCT07086456·80 enrolled

Intrahepatic Cholangiocarcinoma1 trial

HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

Active, not recruiting·QQilu Hospital of Shandong University·Phase 2·NCT06239532·28 enrolled

Pancreatic Carcinoma1 trial

Multi-cohort Study of Surufatinib Plus Sintilimab in Metastatic NEN and Pancreatic Carcinoma Who Failed Standard Chemotherapy

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05627427·60 enrolled

Triple-Negative Breast Cancer1 trial

Surufatinib Combined With Tislelizumab in the Second-line and Further Treatment of Triple-negative Breast Cancer

Unknown status·HHuihua Xiong·Phase 1/2·NCT05746728·45 enrolled

Pulmonary Neuroendocrine Tumor1 trial

Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine Tumors

Recruiting·SShanghai Chest Hospital·Phase 2·NCT07357623·96 enrolled

Hepatic Impairment1 trial

Surufatinib Hepatic Impairment Study

Completed·HHutchison Medipharma Limited·Phase 1·NCT04755075·16 enrolled

Lung Cancer1 trial

Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

Not yet recruiting·NNational Cancer Center, China·Phase 2·NCT06414915·29 enrolled

Nasopharyngeal Carcinoma1 trial

Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma

Unknown status·FFujian Cancer Hospital·Phase 2·NCT04955886·14 enrolled

Differentiated Thyroid Carcinoma1 trial

Study of Sulfatinib in Treating Advanced Medullary Thyroid Carcinoma and Iodine-refractory Differentiated Thyroid Carcinoma

Completed·HHutchison Medipharma Limited·Phase 2·NCT02614495·66 enrolled

Adenocarcinoma1 trial

Surufatinib in Recurrent/Metastatic Head and Neck Adenocarcinomas

Unknown status·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·Phase 2·NCT04910854·27 enrolled

Advanced Solid Tumors With Neuroendocrine Differentiation1 trial

Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation

Not yet recruiting·RRenJi Hospital·Phase 2·NCT06531291·80 enrolled

Salivary Gland Carcinoma1 trial

Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas

Unknown status·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·N/A·NCT05013515·20 enrolled

Appendix Carcinoma1 trial

Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma

Recruiting·SSun Yat-sen University·Phase 2·NCT05472948·36 enrolled

Colorectal Cancer1 trial

Surufatinib Combined With Sintilimab for Advanced MSS-Type Colorectal Cancer : a Phase II Study

Unknown status·FFujian Cancer Hospital·Phase 2·NCT04764006·10 enrolled

Renal Impairment1 trial

Surufatinib Renal Impairment Study

Completed·HHutchison Medipharma Limited·Phase 1·NCT04755088·16 enrolled

Borderline Resectable Pancreatic Cancer1 trial

Neoadjuvant Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for High-risk Resectable or Borderline Resectable Pancreatic Cancer: a Single-arm, Single-center, Exploratory Clinical Study

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT07833241·56 enrolled

Gastric Cancer1 trial

Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: the Phase 2 Solids-01 Trial

Active, not recruiting·FFudan University·Phase 2·NCT06447636·20 enrolled

Advanced Non-Small Cell Lung Cancer1 trial

A Phase II, Single-arm, Two-cohorts, Open-label, Single Center Study of Surufatinib or Surufatinib Combined With Vinorelbine as Third-line and Posterior Line Treatment in Patients With Non-Small Cell Lung Cancer

Active, not recruiting·AAffiliated Cancer Hospital & Institute of Guangzhou Medical University·Phase 2·NCT04922658·76 enrolled

NSCLC (Non-small Cell Lung Cancer)1 trial

A Randomized Phase 2 Study of Hypofractionated Concurrent Chemoradiotherapy Combined With Tislelizumab and Surufatinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Recruiting·SSun Yat-sen University·Phase 2·NCT07609121·160 enrolled

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Surufatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Surufatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Surufatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Hutchison Medipharma Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Fibroblast Growth Factor Receptor 1 Inhibitor; Vascular Endothelial Growth Factor Receptor Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: HHutchison Medipharma Limited

Surufatinib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Surufatinib6 trials

Pancreatic Cancer4 trials

Soft Tissue Sarcoma3 trials

Biliary Tract Cancer3 trials

Biliary Tract Carcinoma3 trials

Pancreatic Neuroendocrine Tumor3 trials

Chemotherapy2 trials

Hepatocellular Carcinoma2 trials

Patients With Advanced Solid Tumors2 trials

Small Cell Lung Cancer2 trials

Neuroendocrine Tumors2 trials

Ovarian Cancer2 trials

Thyroid Cancer2 trials

Advanced Solid Tumors1 trial

Neuroendocrine Neoplasm1 trial

Non-Small Cell Lung Cancer1 trial

Intrahepatic Cholangiocarcinoma1 trial

Pancreatic Carcinoma1 trial

Triple-Negative Breast Cancer1 trial

Pulmonary Neuroendocrine Tumor1 trial

Hepatic Impairment1 trial

Lung Cancer1 trial

Nasopharyngeal Carcinoma1 trial

Differentiated Thyroid Carcinoma1 trial

Adenocarcinoma1 trial

Advanced Solid Tumors With Neuroendocrine Differentiation1 trial

Salivary Gland Carcinoma1 trial

Appendix Carcinoma1 trial

Colorectal Cancer1 trial

Renal Impairment1 trial

Borderline Resectable Pancreatic Cancer1 trial

Gastric Cancer1 trial

Advanced Non-Small Cell Lung Cancer1 trial

NSCLC (Non-small Cell Lung Cancer)1 trial

References

Drug Info

Quick Facts

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