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Zanidatamab - BeiGene/Jazz Pharmaceuticals Inc/Zymeworks

Drug Profile

Zanidatamab - BeiGene/Jazz Pharmaceuticals Inc/Zymeworks

Alternative Names: JZP-598; Zani - BeiGene/Jazz Pharmaceuticals Inc/Zymeworks; ZW 25

Latest Information Update: 13 Jun 2024

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At a glance

  • Originator Zymeworks
  • Developer ALX Oncology; BeiGene; Canadian Cancer Trials Group; Jazz Pharmaceuticals Inc; Zymeworks
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulants; ERBB 2 receptor antagonists; Phagocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Gastric cancer; Biliary cancer; Ovarian cancer
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Biliary cancer
  • Phase III Colorectal cancer; Gastric cancer; Oesophageal cancer
  • Phase II Endometrial cancer; Gastrointestinal cancer; HER2 positive breast cancer
  • Phase I/II Solid tumours
  • No development reported Ovarian cancer

Most Recent Events

  • 13 Jun 2024 NMPA accepts BLA for Zanidatamab for Biliary tract cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Monotherapy, Second-line therapy or greater) for review
  • 01 Jun 2024 Preregistration for Biliary cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Monotherapy, Second-line therapy or greater) in European Union (IV) prior to June 2024
  • 01 Jun 2024 Updated efficacy and adverse events data from the phase IIb HERIZON-BTC-01 trial in Biliary cancer released by Jazz Pharmaceuticals
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