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BAT8001 for injection — Competitive Intelligence Brief
phase 3
Bispecific monoclonal antibody
Oncology
Biologic
Live · refreshed every 30 min
Target snapshot
BAT8001 for injection (BAT8001 for injection) — Bio-Thera Solutions. BAT8001 is a bispecific antibody that simultaneously engages tumor-associated antigens and immune effector cells to enhance anti-tumor immunity.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| BAT8001 for injection TARGET | BAT8001 for injection | Bio-Thera Solutions | phase 3 | Bispecific monoclonal antibody | ||
| SHR-A1811 for Injection | SHR-A1811 for Injection | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | phase 3 | Bispecific monoclonal antibody; dual checkpoint inhibitor | ||
| Ponatinib + Blinatumomab | Ponatinib + Blinatumomab | Gruppo Italiano Malattie EMatologiche dell'Adulto | phase 3 | Tyrosine kinase inhibitor, Bispecific monoclonal antibody | BCR-ABL1, CD19, CD3 | |
| AK117 in combination with AK112 | AK117 in combination with AK112 | Akeso | phase 3 | Bispecific monoclonal antibody | PD-1/LAG-3 (AK117) and PD-L1/TIM-3 (AK112) | |
| Amivantamab Intravenous | Amivantamab Intravenous | Janssen Research & Development, LLC | phase 3 | Bispecific monoclonal antibody | EGFR and MET | |
| VB4-845 Injection | VB4-845 Injection | Qilu Pharmaceutical Co., Ltd. | phase 3 | Bispecific monoclonal antibody | VEGF and HER2 | |
| KN026 | KN026 | Shanghai JMT-Bio Inc. | phase 3 | Bispecific monoclonal antibody | HER2 and HER3 |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Bispecific monoclonal antibody class)
- Akeso · 1 drug in this class
- Bio-Thera Solutions · 1 drug in this class
- Fujian Akeylink Biotechnology Co., Ltd. · 1 drug in this class
- Janssen Research & Development, LLC · 1 drug in this class
- Qilu Pharmaceutical Co., Ltd. · 1 drug in this class
- Shanghai JMT-Bio Inc. · 1 drug in this class
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. · 1 drug in this class
- Xianmin Song, MD · 1 drug in this class
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Cite this brief
Drug Landscape (2026). BAT8001 for injection — Competitive Intelligence Brief. https://druglandscape.com/ci/bat8001-for-injection. Accessed 2026-06-10.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing