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Toripalimab monotherapy
Toripalimab monotherapy is a PD-1 inhibitor Small molecule drug developed by Henan Cancer Hospital. It is currently in Phase 3 development for Metastatic non-small cell lung cancer, PD-L1 positive, Nasopharyngeal carcinoma.
Toripalimab is a PD-1 inhibitor that blocks the PD-1 receptor on T cells, preventing its interaction with PD-L1 on tumor cells and thereby enhancing anti-tumor immune responses.
Toripalimab is a programmed cell death protein 1 antagonist, classified as an antibody, used as a monotherapy for treating advanced urothelial carcinoma. It is indicated for conditions such as urothelial carcinoma, urothelial carcinoma of the bladder, and urothelial carcinoma of the renal pelvis and ureter.
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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 | Toripalimab monotherapy |
|---|---|
| Sponsor | Henan Cancer Hospital |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By blocking the PD-1/PD-L1 interaction, toripalimab allows T cells to recognize and attack cancer cells more effectively. This mechanism is thought to be responsible for its anti-tumor activity in various types of cancer.
Approved indications
- Metastatic non-small cell lung cancer, PD-L1 positive
- Nasopharyngeal carcinoma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pyrexia
Key clinical trials
- Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors (PHASE2)
- Study of CHS-114 in Participants With Advanced Solid Tumors (PHASE1)
- Window of Opportunity in Preserving Laryngeal Function Trial (PHASE2)
- A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer (PHASE1, PHASE2)
- A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors (PHASE1, PHASE2)
- A Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer (PHASE2, PHASE3)
- Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial (PHASE3)
- Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial (PHASE3)
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:
- Toripalimab monotherapy CI brief — competitive landscape report
- Toripalimab monotherapy updates RSS · CI watch RSS
- Henan Cancer Hospital portfolio CI
Frequently asked questions about Toripalimab monotherapy
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Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Henan Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic non-small cell lung cancer, PD-L1 positive
- Indication: Drugs for Nasopharyngeal carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing