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iza-bren izalontamab brengitecan lyophilized powder for injection 120mg per vial

Description

 Indication & Scope

Dual-target EGFR/HER3 ADC infusion drug for post two-line therapy recurrent metastatic nasopharyngeal carcinoma.

  • Mechanism: Bispecific ADC targeting EGFR and HER3, delivers topoisomerase I toxin into tumor cells; exerts bystander killing effect to overcome single-target resistance.
  • Drug class: EGFR/HER3 bispecific antibody-drug conjugate (ADC) for IV infusion
  • Clinical use: Treatment of recurrent/metastatic nasopharyngeal carcinoma in adults progressed after at least two lines of chemotherapy combined with PD-1/PD-L1 inhibitors.
Specification
Generic Name Izalontamab Brengitecan
Brand Name iza-bren® / YiKangZe
Ingredient Each vial contains 120 mg izalontamab brengitecan lyophilized powder
Dosage Form Lyophilized Powder for Injection
Package 1 vial per carton
Conditions Treated Recurrent or metastatic nasopharyngeal carcinoma in adults who failed at least two lines of chemotherapy combined with PD-1/PD-L1 inhibitors
Taboos Severe hypersensitivity to ADC components; active uncontrolled infection; pregnant women
Place of origin China
Prescription type Prescription Drug (Rx)
Storage Conditions Refrigerate at 2–8°C, protect from light, do not shake violently after reconstitution
Manufacturer Sichuan Biokin Pharmaceutical Co., Ltd.
Registration Authority National Medical Products Administration (NMPA)
Approval number CXSS2500124
Date of Revision To be determined
Shelf Life 24 months

How to use ?

Recommended Dose: 120 mg per intravenous infusion.

 

Time: Administer on Days 1 and 8 of each 21-day cycle.

 

Instructions for use: For intravenous infusion only; administer according to the recommended dosing schedule.

 

Interaction: No clinically significant drug interactions reported.

 

Side effects: low white blood cell counts,fatigue,nausea,anemia (low red blood cells).

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, indication, 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

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What is Iza-Bren?

Iza-bren (izalontamab brengitecan, BL-B01D1) is the world’s first approved EGFR × HER3 bispecific ADC. It binds both EGFR and HER3—two oncogenic receptors highly abundant in multiple epithelial cancers that fuel cancer growth and survival signals.

What are the results of iza bren?

Iza-bren outperformed standard chemotherapy by significantly extending patients’ PFS and OS with clinically meaningful benefits. Its manageable safety profile validates it as a new standard treatment for heavily pre-treated late-stage nasopharyngeal carcinoma patients.

How does Iza Bren work?

EGFR and HER3 are commonly co-expressed and functionally interact on solid tumor cells, allowing cancers to escape single-target therapy via compensatory signaling pathways. Iza-bren (Izalontamab brengitecan, BL-B01D1) is a first-in-class EGFR×HER3 bispecific ADC constructed with a dual-target antibody, tumor-specific cleavable linker and novel Topo-I inhibitor payload Ed-04.
Its dual mechanism acts in two layers: it simultaneously blocks both EGFR and HER3 growth signals to cut off tumor survival pathways; after internalization into cancer cells, the released toxin induces tumor cell death, plus robust bystander killing effect eliminates surrounding tumor cells and reduces resistance risks.

What is the approved indication of Iza-bren?

It is approved for adult patients with recurrent/metastatic nasopharyngeal carcinoma that progressed after at least two lines of systemic platinum-based chemotherapy plus PD-1/PD-L1 inhibitor therapy.

Iza-bren® Izalontamab Brengitecan | Recurrent/Metastatic Nasopharyngeal Carcinoma | DengYueRX

INN: Izalontamab brengitecan
Indications: ER+/HER2-/ESR1-mutated advanced/metastatic breast cancer
Dosage Form: Lyophilized Powder for Injection
Strength: 120 mg/vial

 

Low MOQ

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