Description
Indication & Scope
Zuberitamab is an anti-CD20 monoclonal antibody for adult patients with CD20-positive diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), applied in first-line lymphoma treatment and must be combined with standard CHOP chemotherapy.
- Mechanism
As human-mouse chimeric anti-CD20 IgG1 monoclonal antibody, it specifically binds CD20 antigen on B lymphocytes to trigger ADCC and CDC effects, eliminating malignant B cells and suppressing lymphoma progression. - Drug class
Class 1 therapeutic biological product, chimeric anti-CD20 monoclonal antibody, hematologic malignancy targeted therapeutic agent. - Clinical use
Phase III clinical trials verified its superior complete remission rate and controllable safety combined with CHOP chemotherapy; clinically administered via intravenous infusion at single dose of 375mg/m² body surface area on Day 1 of each cycle, the first domestic innovative anti-CD20 mAb for untreated DLBCL patients.
| Generic Name | Zuberitamab Injection |
| Brand Name | AnRuiXi® |
| Ingredient | Zuberitamab |
| Dosage Form | Solution for injection |
| Package | 100mg(10ml)/vial |
| Conditions Treated | Treated For adult patients with CD20-positive diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), to be used in combination with standard CHOP chemotherapy |
| Taboos | Contraindicated for patients with hypersensitivity to the active ingredient or any excipients of this product, or those with severe allergic history |
| Place of origin | Zhejiang, China |
| Priscription Type | Prescription drug (Rx) |
| Storage Conditions | Store at 2–8℃, avoid freezing and light |
| Manufacturer | Zhejiang Borui Biopharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA) |
| Approval number | S20230028 |
| Date of Revision | May 17, 2023 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose:375 mg/m² body surface area, intravenous infusion on Day 1 of each CHOP cycle for up to 6 cycles.
Time: Complete infusion within 3–4 hours; prepared diluted solution can be stored at 2–8℃ for up to 12 hours, avoid freezing.
Interaction:For intravenous infusion only, do not mix with other medicines in the same infusion line. Pre-medicate with antihistamines and antipyretics before administration. Must be combined with CHOP chemotherapy regimen.
Side effects:Side effects: Mild to moderate reactions common: infusion-related fever, fatigue, neutropenia, anemia, elevated liver enzymes. Rare hypersensitivity, rash; severe anaphylaxis and interstitial lung disease are very rare.
Important Notice
This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.
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 mechanism of action of Zuberitamab?
Antibody-Dependent Cellular Cytotoxicity (ADCC).
Can Zuberitamab be used alone for treatment?
No, it must be combined with CHOP chemotherapy regimen.
What therapeutic category does the drug belong to?
Oncology, Hematologic Malignancies.
What premedication should be given before infusion?
Antihistamines and antipyretics are required before administration.
AnRuiXi®Zuberitamab Injection | DLBCL | DengYueRX
INN: Zuberitamab
Indications: DLBCL (Diffuse Large B-cell Lymphoma)
Dosage Form: Solution for infusion
Strength: 100mg(10ml)/vial
