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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; H-drug; Han Si Zhuang; HANSIZHUANG; Hanszol®; Hetronifly; HLX-10; Olizu; Recombinant humanized anti-PD-1 monoclonal antibody - Shanghai Henlius Biotech; SERPLUMA; Zerpidio

Latest Information Update: 28 Aug 2026

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At a glance

  • Originator Henlix Biotech
  • Developer Alvogen Korea; 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
  • Registered Gastric cancer
  • Preregistration Squamous cell cancer
  • Phase III Colorectal cancer
  • Phase II/III Adenocarcinoma
  • Phase II Cervical cancer; Hepatitis B; Liver cancer; Nasopharyngeal cancer
  • Clinical Phase Unknown Rectal cancer
  • No development reported Lymphoma

Most Recent Events

  • 28 Aug 2026 No recent reports of development identified for preclinical development in Lymphoma in China (IV)
  • 13 Jul 2026 Shanghai Henlius Biotech completes the phase III ASTRUM-006 trial in Gastric cancer (Combination therapy) in China (IV) prior to July 2026 (NCT04139135)
  • 03 Jul 2026 Registered for Small cell lung cancer (First-line therapy, Combination therapy) in South Korea (IV)

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