Description
Indication & Scope
VYLOY® Zolbetuximab for Injection treats locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2 and negative for HER2.
- Mechanism: Monoclonal antibody binds specifically to Claudin 18.2 on gastric tumor cells, triggers antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to eliminate malignant cells.
- Drug class: CLDN18.2 targeted monoclonal antibody, anti-neoplastic biologic agent.
- Clinical use: First-line targeted therapy for CLDN18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma.
| Generic Name | Zolbetuximab for Injection |
| Brand Name | VYLOY |
| Ingredient | Zolbetuximab for Injection |
| Dosage Form | Injection |
| Package | 100mg*1 vial/box; 300mg*1 vial/box |
| Conditions Treated | CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma |
| Taboos | Severe anaphylactic hypersensitivity to zolbetuximab or excipients, active uncontrolled severe infections, patients with severe autoimmune disorders, pregnant women |
| Place of origin | Kantstraβe 2, 33790, Halle/Westfalen, Germany |
| Prescription type | Prescription-only |
| Storage Conditions | Undiluted concentrate stored at 2°C~8°C, protected from light, prohibit freezing |
| Manufacturer | Astellas Pharma Europe B.V. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | SJ20240050; S20269004 |
| Approval Date | Dec 25, 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Weight-based loading dose followed by maintenance dose per treatment cycle.
Time: Intravenous infusion given every 3 weeks on a repeating cycle.
Instructions for use: Dilute with approved infusion medium, administer slow intravenous infusion with premedication for hypersensitivity prevention.
Interaction: Concurrent cytotoxic chemotherapy increases gastrointestinal and hematological adverse effects; close toxicity monitoring is required.
Side effects: Nausea, vomiting, fatigue, neutropenia, infusion-related hypersensitivity reactions, constipation.
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 is the approved indication of Zolbetuximab for Injection?
It treats CLDN18.2-positive and HER2-negative locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
How does Zolbetuximab for Injection kill gastric cancer cells?
It binds CLDN18.2 on tumor cells to trigger ADCC and CDC immune responses to eliminate malignant cells.
What is the administration method of Zolbetuximab for Injection?
It is diluted and administered through slow intravenous infusion every three weeks.
Which patients are contraindicated from Zolbetuximab for Injection?
Patients with severe hypersensitivity, uncontrolled severe infections and severe autoimmune diseases cannot use it.
VYLOY® | Zolbetuximab for Injection | Adenocarcinoma | DengYueRX
INN: Zolbetuximab for Injection
Indications: Adenocarcinoma
Dosage Form: Injection
Strength: 100mg/vial; 300mg/vial
