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Shanghai Henlius Biotech — Portfolio Competitive Intelligence Brief

Shanghai Henlius Biotech pipeline: 2 marketed, 0 filed, 20 Phase 3, 8 Phase 2. Recent regulatory actions, upcoming PDUFA, patent timeline, top competitor overlap.

2 marketed 0 filed 20 Phase 3 8 Phase 2 30 Phase 1 Live · 30-min refresh

Portfolio leaders (marketed + Phase 3 / filed)

DrugGenericPhaseClassTargetAreaFirst approval
POHERDY PERTUZUMAB-DPZB marketed Other
Darzalex Darzalex marketed Lymphocyte differentiation antigen CD38 Oncology
HLX03 HLX03 phase 3 PD-L1 inhibitor PD-L1 Oncology
HLX04 HLX04 phase 3 VEGF inhibitor (monoclonal antibody / bevacizumab biosimilar) VEGF (Vascular Endothelial Growth Factor) Oncology
EU-sourced Keytruda® EU-sourced Keytruda® phase 3 PD-1 inhibitor PD-1 Oncology
HLX10, an engineered anti-PD-1 antibody HLX10, an engineered anti-PD-1 antibody phase 3 PD-1 inhibitor PD-1 Oncology
HLX10 HLX10 phase 3 PD-L1 inhibitor PD-L1 Oncology
carboplatin and nab paclitaxel carboplatin and nab paclitaxel phase 3 Chemotherapy combination (platinum agent + taxane) DNA (carboplatin); β-tubulin (nab-paclitaxel) Oncology
EU-sourced YERVOY® EU-sourced YERVOY® phase 3 CTLA-4 inhibitor CTLA-4 Oncology
EU-Perjeta® EU-Perjeta® phase 3 HER2 inhibitor monoclonal antibody HER2 (Human Epidermal Growth Factor Receptor 2) Oncology
HLX04-O HLX04-O phase 3 VEGF inhibitor (monoclonal antibody / bevacizumab biosimilar) VEGF (Vascular Endothelial Growth Factor) Oncology
HLX17 HLX17 phase 3 PD-L1 inhibitor PD-L1 Oncology

Therapeutic area mix

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Patent timeline (forward window)

No upcoming patent expiries for this portfolio.

Competitive overlap (companies sharing drug classes)

  1. AstraZeneca · 3 shared drug classes
  2. RemeGen Co., Ltd. · 3 shared drug classes
  3. Jiangsu HengRui Medicine Co., Ltd. · 3 shared drug classes
  4. Innovent Biologics (Suzhou) Co. Ltd. · 2 shared drug classes
  5. GlaxoSmithKline · 2 shared drug classes
  6. Hoffmann-La Roche · 2 shared drug classes
  7. Celltrion · 2 shared drug classes
  8. 3D Medicines (Sichuan) Co., Ltd. · 2 shared drug classes

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Cite this brief

Drug Landscape (2026). Shanghai Henlius Biotech — Portfolio Competitive Intelligence Brief. https://druglandscape.com/ci/company/shanghai-henlius-biotech. Accessed 2026-05-16.

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