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Tirelizumab
Tirelizumab is a Small molecule drug developed by Sichuan Cancer Hospital and Research Institute. It is currently in Phase 2 development. Also known as: PD-1 antibody, anti-PD-1 monoclonal antibody.
Tirelizumab is an immunotherapy being studied in clinical trials for various conditions, including Esophageal Squamous Cell Carcinoma, Advanced Solid Tumor, and Triple-Negative Breast Cancer. It is typically used in combination with other treatments, such as Nab paclitaxel and Carboplatin, in these trials.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Tirelizumab |
|---|---|
| Also known as | PD-1 antibody, anti-PD-1 monoclonal antibody |
| Sponsor | Sichuan Cancer Hospital and Research Institute |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Tirellizumab Combined With TP Neoadjuvant Therapy in the Treatment of Early Oral Squamous Cell Carcinoma （HNC-SYSU-005） (PHASE2)
- Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma (PHASE2)
- Selected Chemotherapy Combined Immunotherapy Treated High Risk Patient After NCRT in Resected Locally Advanced ESCC (PHASE2)
- A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours (PHASE1, PHASE2)
- Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC (NA)
- A Real-world Study of the Efficacy and Safety of PD-1 Inhibitors Combined With Chemoradiotherapy in Lung Metastatic Nasopharyngeal Carcinoma (NA)
- Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients (PHASE2)
- Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma (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:
- Tirelizumab CI brief — competitive landscape report
- Tirelizumab updates RSS · CI watch RSS
- Sichuan Cancer Hospital and Research Institute portfolio CI
Frequently asked questions about Tirelizumab
What is Tirelizumab?
Who makes Tirelizumab?
Is Tirelizumab also known as anything else?
What development phase is Tirelizumab in?
Related
- Manufacturer: Sichuan Cancer Hospital and Research Institute — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: PD-1 antibody, anti-PD-1 monoclonal antibody
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing