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Pucotenlimab - Lepu Biopharma

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Drug Profile

Pucotenlimab - Lepu Biopharma

Alternative Names: Anti-PD-1-antibody - Lepu Biopharma; HX-008; Puyouheng; Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection - Lepu Biopharma

Latest Information Update: 24 Jul 2026

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At a glance

  • Originator Akeso Biopharma; HanX Biopharmaceuticals
  • Developer Lepu Biopharma; Sun Yat-Sen University
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Malignant melanoma; Solid tumours
  • Phase III Adenocarcinoma; Gastrointestinal cancer
  • Phase II/III Non-small cell lung cancer
  • Phase II Bladder cancer; Breast cancer; Liver cancer; Nasopharyngeal cancer; Squamous cell cancer; Triple negative breast cancer
  • Phase 0 Gastric cancer

Most Recent Events

  • 06 Jul 2026 Phase-II clinical trials in Squamous cell cancer (Combination therapy, Late-stage disease) in China (IV) (NCT07586124)
  • 20 May 2026 Lepu Biopharma plans a phase II trial in Squamous cell cancer (Late-stage disease, Combination therapy) in China (IV) (NCT07586124)
  • 17 Oct 2025 Efficacy and adverse events data from a phase I/II trial in Solid tumours presented at the 50th European Society for Medical Oncology Congress (ESMO-2025)

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