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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: 09 Jan 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

  • 09 Dec 2023 Phase II clinical trial for Cholangiocarcinoma (Inoperable/Unresectable) in China (Parenteral) (NCT06192784)
  • 05 Dec 2023 Efficacy and adverse events data from a phase I/II trial in Triple-negative-breast cancer presented at the 46th Annual San Antonio Breast Cancer Symposium (SABCS-2023)
  • 20 Oct 2023 Efficacy and adverse events data from a phase II/III trial in Non-small cell lung cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)
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