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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: 20 Aug 2025

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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; Biliary cancer; Ovarian cancer
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 07 Aug 2025 Launched for Biliary cancer (Late-stage disease, Inoperable/Unresectable, Metastatic disease, Monotherapy, Second-line therapy or greater) in China (IV)
  • 03 Aug 2025 Jazz Pharmaceuticals plans a phase II EmpowHER 208 trial for HER2-positive breast cancer (Early-stage disease, Combination therapy) in unknown location in September 2025 (NCT07102381)
  • 01 Aug 2025 Phase-II clinical trials in HER2-positive-breast-cancer (Early-stage disease, Combination therapy, Neoadjuvant therapy, Adjuvant therapy) (IV) (NCT07102381)

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