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Serplulimab - Shanghai Henlius Biotech

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Drug Profile

Serplulimab - Shanghai Henlius Biotech

Alternative Names: Anti-PD-1 monoclonal antibody - Shanghai Henlius Biotech; Anti-PD-I mAb - Shanghai Henlius Biotech; Han Si Zhuang; HANSIZHUANG; Hetronifly; HLX-10; Recombinant humanized anti-PD-1 monoclonal antibody - Shanghai Henlius Biotech; Zerpidio

Latest Information Update: 14 Oct 2025

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At a glance

  • Originator Henlix Biotech
  • Developer Henlix Biotech; Intas Pharmaceuticals; PT Kalbe Genexine Biologics; Shanghai Henlius Biotech
  • Class Antineoplastics; Antivirals; 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.

    Yes - Small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer; Oesophageal cancer; Small cell lung cancer; Solid tumours
  • Phase III Colorectal cancer; Gastric cancer
  • Phase II/III Adenocarcinoma
  • Phase II Cervical cancer; Hepatitis B; Liver cancer; Nasopharyngeal cancer; Squamous cell cancer
  • Preclinical Lymphoma

Most Recent Events

  • 09 Oct 2025 Shanghai Henlius Biotech plans an early NDA submission for Gastric cancer (Adjuvant therapy, Neoadjuvant therapy)
  • 09 Oct 2025 Interim efficacy and adverse events data from the phase III ASTRUM-006 trial in Gastric cancer released by Shanghai Henlius Biotech
  • 28 Sep 2025 No recent reports of development identified for phase-I development in Solid-tumours(Combination therapy, Late-stage disease, Metastatic disease) in China (IV, Injection)

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