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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: 06 Aug 2024

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At a glance

  • Originator Akeso Biopharma; HanX Biopharmaceuticals
  • Developer Lepu Biopharma
  • 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; Triple negative breast cancer

Most Recent Events

  • 31 Jul 2024 Lepu Biopharma plans a phase II trial in Squamous cell cancer (Neoadjuvant therapy, Late-stage disease, First-line therapy, Combination therapy) (IV) in August 2024 (NCT06530914)
  • 28 Jul 2024 No recent reports of development identified for phase-I development in Malignant-melanoma(Combination therapy, Late-stage disease, Metastatic disease) in China (IV, Infusion)
  • 28 Jul 2024 No recent reports of development identified for phase-I development in Solid-tumours(Combination therapy, Inoperable/Unresectable, Metastatic disease, Recurrent, Second-line therapy or greater) in China (IV, Injection)

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