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BAT2506 injection
BAT2506 injection is a Bispecific checkpoint inhibitor Small molecule drug developed by Bio-Thera Solutions. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development).
BAT2506 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T cell responses.
BAT2506 injection is being studied in a clinical trial for the treatment of Psoriatic Arthritis. The study compares the pharmacokinetics and safety of BAT2506 injection to Simponi, a commercially available treatment for Psoriatic Arthritis.
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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 | BAT2506 injection |
|---|---|
| Sponsor | Bio-Thera Solutions |
| Drug class | Bispecific checkpoint inhibitor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BAT2506 functions as a bispecific monoclonal antibody designed to target and modulate multiple immune pathways simultaneously. By engaging dual immune checkpoints, it aims to overcome resistance mechanisms and amplify the body's natural anti-tumor immune response more effectively than single-target checkpoint inhibitors.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events
- Infusion reactions
Key clinical trials
- Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects (PHASE1)
- A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi® (PHASE1)
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:
- BAT2506 injection CI brief — competitive landscape report
- BAT2506 injection updates RSS · CI watch RSS
- Bio-Thera Solutions portfolio CI
Frequently asked questions about BAT2506 injection
What is BAT2506 injection?
How does BAT2506 injection work?
What is BAT2506 injection used for?
Who makes BAT2506 injection?
What drug class is BAT2506 injection in?
What development phase is BAT2506 injection in?
What are the side effects of BAT2506 injection?
Related
- Drug class: All Bispecific checkpoint inhibitor drugs
- Manufacturer: Bio-Thera Solutions — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing