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Tagitanlimab
Tagitanlimab is a Biologic drug developed by West China Hospital. It is currently in Phase 2 development. Also known as: KL-A167.
Tagitanlimab is being studied in combination with sacituzumab tirumotecan as a treatment for various types of cancer, including non-small cell lung cancer, triple negative breast cancer, and head and neck squamous cell carcinoma. It is also being investigated as a potential treatment for estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
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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 | Tagitanlimab |
|---|---|
| Also known as | KL-A167 |
| Sponsor | West China Hospital |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma (PHASE2)
- A Study of SKB315 in Patients With Advanced Solid Tumors (PHASE1)
- Sacituzumab Tirumotecan in Combination With Tagitanlimab in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC) (PHASE2)
- Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer (PHASE2)
- SKB264 Combined With KL-A167 Neoadjuvant Therapy for Early-stage, High-risk ER+/HER2- Breast Cancer (PHASE2)
- A Single-center, Phase II Clinical Trial Evaluating the Efficacy of Sacituzumab Tirumotecan in Combination With Tagitanlimab as Neoadjuvant Therapy for PD-L1-positive, Resectable Stage II to IIIB Non-small Cell Lung Cancer (NSCLC) (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:
- Tagitanlimab CI brief — competitive landscape report
- Tagitanlimab updates RSS · CI watch RSS
- West China Hospital portfolio CI
Frequently asked questions about Tagitanlimab
What is Tagitanlimab?
Who makes Tagitanlimab?
Is Tagitanlimab also known as anything else?
What development phase is Tagitanlimab in?
Related
- Manufacturer: West China Hospital — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: KL-A167
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing