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Immunotherapy,Toripalimab Injection
Immunotherapy,Toripalimab Injection is a PD-1 inhibitor Small molecule drug developed by Eye & ENT Hospital of Fudan University. It is currently in Phase 3 development for Nasopharyngeal carcinoma, Non-small cell lung cancer, Melanoma.
Toripalimab is a monoclonal antibody that blocks PD-1 on immune cells, releasing the brakes on anti-tumor immunity and allowing T cells to recognize and attack cancer cells.
Toripalimab Injection is an immunotherapy that targets the programmed cell death protein 1 (PD-1) as its molecular mechanism. It is used to treat various conditions, including advanced unresectable solid tumors, metastatic solid tumors, recurrent nasopharyngeal carcinoma, resectable stage II-IIIa non-small cell lung cancer, and pancreatic cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Immunotherapy,Toripalimab Injection |
|---|---|
| Sponsor | Eye & ENT Hospital of Fudan University |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Toripalimab binds to programmed death receptor 1 (PD-1) on T cells, preventing interaction with its ligands (PD-L1 and PD-L2) expressed on tumor cells and immune cells. This blockade restores T cell activation, proliferation, and effector function, enabling the immune system to mount an effective anti-tumor response. It is used as an immunotherapy agent in various solid tumors.
Approved indications
- Nasopharyngeal carcinoma
- Non-small cell lung cancer
- Melanoma
- Other solid tumors (in clinical development)
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
- Infusion-related reactions
Key clinical trials
- Clinical Study of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors (PHASE1)
- Safety and Tolerability of a mRNA Vaccine Encoding Tumor-Specific Circular RNA Antigens in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors (PHASE1, PHASE2)
- A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy (PHASE2)
- Adjuvant vs Surgery Only in Early-stage Recurrent NPC (PHASE3)
- Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC. (PHASE2)
- Clinical Study of Therapeutic Immunological Agent for EBV Lymphoproliferative Diseases (PHASE1)
- PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients (PHASE2)
- Newly Emerging Immunotherapy for Pancreatic Cancer Treatment (PHASE1, 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:
- Immunotherapy,Toripalimab Injection CI brief — competitive landscape report
- Immunotherapy,Toripalimab Injection updates RSS · CI watch RSS
- Eye & ENT Hospital of Fudan University portfolio CI
Frequently asked questions about Immunotherapy,Toripalimab Injection
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Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Eye & ENT Hospital of Fudan University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Nasopharyngeal carcinoma
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Melanoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing