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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 Sep 2025

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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

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

Most Recent Events

  • 30 May 2025 Updated efficacy and adverse events data from a phase II trial in Solid tumours and Gastrointestinal cancer presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)
  • 15 May 2025 Phase-II clinical trials in Nasopharyngeal cancer (Combination therapy, In infants, In children, In adolescents, First-line therapy) in China (Parenteral) (NCT06969534)
  • 26 Mar 2025 Lepu Biopharma plans a phase II trial for Squamous Cell Cancer (Neoadjuvant therapy, Combination therapy, First-line therapy, Late-stage disease) in China (NCT06895369)

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