Zanidatamab For Injection 300 mg Suppliers & Bulk Manufacturers
Available Forms: Lyophilised powder vial (IV infusion)
Available Strengths: 300 mg
Reference Brands: Ziihera (Jazz Pharmaceuticals; originator Zymeworks)
Category: Oncology Cancer Care
Zanidatamab (Ziihera) is a bispecific HER2 antibody for previously treated HER2-positive biliary tract cancer, approved in the US (November 2024), China and the EU (2025). PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.
Manufacture or export Zanidatamab For Injection? List it or send an offer →
Product Description:
Zanidatamab is a bispecific antibody that binds two different sites on the HER2 receptor at once, the sites used by trastuzumab and by pertuzumab. Binding both causes HER2 receptors to cluster and be pulled into the cell, blocking their growth signal more completely than a single antibody, and it also recruits the immune system against the tumour.
The US FDA granted accelerated approval as Ziihera in November 2024 for adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. China approved it in May 2025 and the EU gave conditional approval in 2025. It is given by intravenous infusion every two weeks from 300 mg powder vials. Zymeworks discovered it; Jazz Pharmaceuticals markets it in the US and Europe. It is also being studied in HER2-positive gastric and oesophageal cancer.
Sourcing and licensing notes. Zanidatamab is patented and there is no biosimilar. It is a cold-chain product. We confirm registration status for each destination before quoting.
How Zanidatamab For Injection is supplied today, and licensing ahead of patent expiry
Where zanidatamab is approved
Checked 3 Oct 2026| Market | Status | Brand · regulator · date |
|---|---|---|
| United States | Approved | Ziihera · FDA · Nov 2024 (accelerated) |
| China | Approved | NMPA · May 2025 |
| European Union | Approved | Ziihera · European Commission · 2025 (conditional) |
| Generic / biosimilar | None | None approved as of the check date |
Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →
Frequently Asked Questions
Previously treated HER2-positive (IHC 3+) biliary tract cancer that cannot be removed by surgery or has spread.
Ziihera, marketed by Jazz Pharmaceuticals. Zymeworks discovered it.
An antibody that binds two different parts of HER2 at the same time, the sites targeted separately by trastuzumab and pertuzumab.
No. It is patented. We handle authorised-supply enquiries and connect developers and licensees preparing for patent expiry.
Related Products
Telisotuzumab Vedotin For Injection
Strength:
20 mg, 100 mg
Form: Lyophilised powder vial (IV infusion)
Reference Brands: Emrelis (AbbVie)
View DetailsPivekimab Sunirine For Injection
Strength:
2 mg
Form: Lyophilised powder vial (IV infusion)
Reference Brands: Decnupaz (AbbVie)
View DetailsDatopotamab Deruxtecan For Injection
Strength:
100 mg
Form: Lyophilised powder vial (IV infusion)
Reference Brands: Datroway (Daiichi Sankyo / AstraZeneca)
View DetailsSerplulimab Injection
Strength:
100 mg/10 mL
Form: Concentrate vial (IV infusion)
Reference Brands: Hetronifly (EU), Hansizhuang (China) — Shanghai Henlius
View Details
Epirubicin
Strength:
10 / 50 mg
Form: Injection
Reference Brands: Ellence (US), Farmorubicin (EU)
View Details
Usually answered within 48 hours | GMP documents shared before you commit
