Description
Indication & Scope
ZIIHERA® Zanidatamab for Injection provides monotherapy for adult patients with locally advanced or metastatic biliary tract cancer who failed prior systemic treatment.
- Mechanism: Humanized bispecific antibody targeting HER2 extracellular domain; dual binding to two distinct HER2 epitopes, inhibits HER2 dimerization, blocks downstream PI3K/AKT tumor signaling, mediates antibody-dependent cell-mediated cytotoxicity to kill HER2-expressing biliary tumor cells.
- Drug class: HER2-targeted bispecific monoclonal antibody, injectable anti-tumor prescription biologic drug.
- Clinical use: Late-line targeted monotherapy for refractory HER2-positive advanced biliary tract carcinoma.
| Generic Name | Zanidatamab for Injection |
| Brand Name | ZIIHERA |
| Ingredient | Zanidatamab |
| Dosage Form | Injection |
| Package | 300mg*1 vial/box |
| Conditions Treated | Locally advanced and metastatic biliary tract cancer |
| Taboos | Severe hypersensitivity to zanidatamab or antibody formulation excipients; patients with active uncontrolled interstitial lung disease; pregnant women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Unreconstituted vials stored at 2°C–8°C, light-proof, no freezing |
| Manufacturer | BaiJiShenZhou Biotechnology, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250030 |
| Approval Date | May 27, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Fixed weight-based intravenous infusion administered once every 21 days per treatment cycle.
Time: Infusion performed on day 1 of each 21-day cycle until disease progression or intolerable toxicity.
Instructions for use: Reconstitute and dilute with 0.9% normal saline for slow intravenous drip; premedicate with antihistamines to prevent infusion hypersensitivity reactions.
Interaction: Concomitant cytotoxic chemotherapy increases myelosuppression risk; no antagonistic interactions with other targeted agents.
Side effects: Diarrhea, fatigue, elevated liver transaminases, neutropenia, infusion-related fever and rash.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What type of cancer does Zanidatamab for Injection treat?
It is used for late-line treatment of locally advanced and metastatic biliary tract cancer.
What is the unique structural feature of Zanidatamab for Injection?
It is a humanized bispecific antibody targeting two different epitopes of the HER2 protein.
What is the core anti-tumor mechanism of Zanidatamab for Injection?
It inhibits HER2 signaling pathway and triggers immune-mediated tumor cell killing.
What are the main adverse reactions of Zanidatamab for Injection?
Diarrhea, elevated liver enzymes, neutropenia and infusion-related reactions are commonly observed.
ZIIHERA® | Zanidatamab for Injection | Biliary Tract Cancer | DengYueRX
INN: Zanidatamab for Injection
Indications: Biliary tract cancer
Dosage Form: Injection
Strength: 300mg/vial
