Zanidatamab - BeiGene/Jazz Pharmaceuticals Inc/Zymeworks
Alternative Names: JZP-598; Zani - BeiGene/Jazz Pharmaceuticals Inc/Zymeworks; ZW 25Latest Information Update: 13 Jun 2024
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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