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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; HLX-10; Recombinant humanized anti-PD-1 monoclonal antibody - Shanghai Henlius Biotech; Zerpidio

Latest Information Update: 04 Nov 2024

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At a glance

  • Originator Henlix Biotech
  • Developer Henlix Biotech; 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 Gastric cancer
  • Phase II/III Adenocarcinoma
  • Phase II Cervical cancer; Colorectal cancer; Hepatitis B; Liver cancer; Nasopharyngeal cancer; Squamous cell cancer
  • Preclinical Lymphoma

Most Recent Events

  • 24 Oct 2024 Phase-II/III clinical trials in Adenocarcinoma (Combination therapy, Metastatic disease, Inoperable/Unresectable) in Indonesia (IV), prior to October 2024
  • 24 Oct 2024 Phase-II/III clinical trials in Adenocarcinoma (Combination therapy, Metastatic disease, Inoperable/Unresectable) in Japan (IV)
  • 21 Sep 2024 CHMP recommends approval of serplulimab for Small cell lung cancer in European Union

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