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SHR-A2009 monotherapy — Competitive Intelligence Brief

SHR-A2009 monotherapy (SHR-A2009 monotherapy) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Bispecific monoclonal antibody. Area: Oncology.

phase 3 Bispecific monoclonal antibody Oncology Small molecule Live · refreshed every 30 min

Target snapshot

SHR-A2009 monotherapy (SHR-A2009 monotherapy) — Suzhou Suncadia Biopharmaceuticals Co., Ltd.. SHR-A2009 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T-cell responses.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
SHR-A2009 monotherapy TARGET SHR-A2009 monotherapy Suzhou Suncadia Biopharmaceuticals Co., Ltd. phase 3 Bispecific monoclonal antibody
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
Cadonilimab (AK104) Cadonilimab (AK104) Guangxi Medical University phase 3 Bispecific monoclonal antibody; dual checkpoint inhibitor PD-L1 and TIM-3
GST-HG141 GST-HG141 Fujian Akeylink Biotechnology Co., Ltd. phase 3 Bispecific monoclonal antibody
Ponatinib + Blinatumomab Ponatinib + Blinatumomab Gruppo Italiano Malattie EMatologiche dell'Adulto phase 3 Tyrosine kinase inhibitor, Bispecific monoclonal antibody BCR-ABL1, CD19, CD3
BAT8001 for injection BAT8001 for injection Bio-Thera Solutions phase 3 Bispecific monoclonal antibody

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). SHR-A2009 monotherapy — Competitive Intelligence Brief. https://druglandscape.com/ci/shr-a2009-monotherapy. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing