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Surufatinib plus Toripalimab
Surufatinib inhibits multiple receptor tyrosine kinases (FGFR, VEGFR, RET) to block tumor angiogenesis and growth, while toripalimab is a PD-1 inhibitor that restores anti-tumor immune responses.
Surufatinib inhibits multiple receptor tyrosine kinases (FGFR, VEGFR, RET) to block tumor angiogenesis and growth, while toripalimab is a PD-1 inhibitor that restores anti-tumor immune responses. Used for Advanced or metastatic neuroendocrine tumors (NET), Advanced hepatocellular carcinoma.
At a glance
| Generic name | Surufatinib plus Toripalimab |
|---|---|
| Also known as | HMPL-012 plus JS001 |
| Sponsor | Hutchison Medipharma Limited |
| Drug class | Tyrosine kinase inhibitor + PD-1 inhibitor combination |
| Target | FGFR, VEGFR, RET (surufatinib); PD-1 (toripalimab) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This combination pairs a multi-targeted tyrosine kinase inhibitor with an immune checkpoint inhibitor. Surufatinib targets fibroblast growth factor receptors, vascular endothelial growth factor receptors, and RET to suppress tumor vasculature and proliferation. Toripalimab blocks PD-1 on T cells, releasing immune suppression and enabling the immune system to attack cancer cells. Together, they provide both direct anti-angiogenic/anti-proliferative effects and immune activation.
Approved indications
- Advanced or metastatic neuroendocrine tumors (NET)
- Advanced hepatocellular carcinoma
Common side effects
- Hypertension
- Proteinuria
- Fatigue
- Diarrhea
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
- Palmar-plantar erythrodysesthesia
Key clinical trials
- Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer (PHASE2)
- Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer (PHASE2)
- Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma (PHASE2)
- A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer. (PHASE2)
- Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma (NA)
- A Phase 3 Study to Evaluate Surufatinib Plus Toripalimab in the Treatment of Advanced Neuroendocrine Carcinoma (PHASE3)
- Surufatinib Combined With Toripalimab and AG Regiments for First-line Treatment of Unresectable or Relapsing Metastatic Ampullary Carcinoma (PHASE2)
- Surufatinib, Toripalimab and Chemotherapy in Second-line MT and MSS CRC (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Surufatinib plus Toripalimab CI brief — competitive landscape report
- Surufatinib plus Toripalimab updates RSS · CI watch RSS
- Hutchison Medipharma Limited portfolio CI