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Surufatinib

Phase 3

Neuroendocrine Tumors | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Sep 15, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment450
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02588170Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine TumorsPHASE3 COMPLETED 219Dec 7, 2015Jul 7, 2022Mar 30, 20235 China
NCT02589821Phase III Study of Surufatinib in Treating Advanced Pancreatic Neuroendocrine TumorsPHASE3 COMPLETED 195Dec 7, 2015Jul 7, 2022Mar 30, 20235 China
NCT05077384Open-label Study of Surufatinib in Japanese PatientsPHASE1/PHASE2 COMPLETED 36Sep 1, 2021Jan 1, 2025Sep 15, 2025 -
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Study Endpoints
Primary Endpoints
Progression Free Survival (PFS)
9 months after the last patient enrolled

the duration between the randomization date and the first disease progression (PD) or death (whichever comes first).

Secondary Endpoints
The objective response rate of the tumor (ORR)
9 months after the last patient enrolled
The disease control rate (DCR)
9 months after the last patient enrolled
Duration of Response (DoR)
9 months after the last patient enrolled
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SurufatinibEXPERIMENTALSurufatinib 300 mg, orally, once daily (QD)
PlaceboPLACEBO_COMPARATORPlacebo 300 mg, orally, once daily (QD)
Interventions
NameTypeDescription
SurufatinibDRUGSurufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
PlaceboOTHERPlacebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Adequately understand the study and voluntarily sign the Informed Consent Form; 2. Be at least 18 years old; 3. Based on central pathology review results,patients have a confirmed histologically pathology diagnosis of low- or intermediate grade (G1 or G2) advanced (unresectab...

Countries:China
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