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TQB2450(blank)
TQB2450(blank) is a PD-1 inhibitor Small molecule drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma.
TQB2450 is a monoclonal antibody targeting PD-1.
TQB2450 is an antibody being studied in clinical trials for the treatment of Stage III Non-small-cell Lung Cancer and Extensive Small Cell Lung Cancer. It is being compared to Anlotinib and a placebo in a randomized, double-blind study.
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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 | TQB2450(blank) |
|---|---|
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
TQB2450 works by binding to PD-1, a protein on the surface of immune cells, thereby blocking its interaction with its ligands PD-L1 and PD-L2. This blockade releases the brakes on the immune system, allowing it to attack cancer cells more effectively.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
- Head and neck squamous cell carcinoma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pyrexia
Key clinical trials
- A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC) (PHASE3)
- A Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer (ETER701) (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:
- TQB2450(blank) CI brief — competitive landscape report
- TQB2450(blank) updates RSS · CI watch RSS
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. portfolio CI
Frequently asked questions about TQB2450(blank)
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Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
- Indication: Drugs for Head and neck squamous cell carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing