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Zanidatamab - BeOne Medicines/Jazz Pharmaceuticals/Zymeworks

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Drug Profile

Zanidatamab - BeOne Medicines/Jazz Pharmaceuticals/Zymeworks

Alternative Names: JZP-598; Zani - BeOne Medicines/Jazz Pharmaceuticals Inc/Zymeworks; Zanidatamab-hrii; Ziihera; ZW 25

Latest Information Update: 03 Sep 2026

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At a glance

  • Originator Zymeworks
  • Developer ALX Oncology; BeOne Medicines; Jazz Pharmaceuticals Inc; Zymeworks
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulants; 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; Oesophageal cancer; Biliary cancer; Ovarian cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Biliary cancer
  • Registered Adenocarcinoma
  • Preregistration Gastric cancer; Oesophageal cancer
  • Phase III Colorectal cancer; HER2 positive breast cancer
  • Phase II Endometrial cancer; Solid tumours
  • Discontinued Ovarian cancer

Most Recent Events

  • 31 Aug 2026 Efficacy and adverse event data from the phase III HERIZON-GEA-01 trial in Adenocarcinoma released by Zymeworks
  • 25 Aug 2026 Registered for Adenocarcinoma (Metastatic disease, Inoperable/Unresectable, Late-stage disease, Combination therapy, First-line therapy) in USA (IV)
  • 05 Aug 2026 BeOne Medicines expects regulatory approval for zanidatamab Adenocarcinoma (First line therapy, Combination therapy) in China in the first half of 2027

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