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BAT8001 for injection — Competitive Intelligence Brief

BAT8001 for injection (BAT8001 for injection) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Bispecific monoclonal antibody. Area: Oncology.

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)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / 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)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Bispecific monoclonal antibody class)

  1. Akeso · 1 drug in this class
  2. Bio-Thera Solutions · 1 drug in this class
  3. Fujian Akeylink Biotechnology Co., Ltd. · 1 drug in this class
  4. Janssen Research & Development, LLC · 1 drug in this class
  5. Qilu Pharmaceutical Co., Ltd. · 1 drug in this class
  6. Shanghai JMT-Bio Inc. · 1 drug in this class
  7. Suzhou Suncadia Biopharmaceuticals Co., Ltd. · 1 drug in this class
  8. 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