Description
Indication & Scope
AiWeiDa® Trastuzumab Rezetecan for Injection provides treatment for locally advanced or metastatic non-small cell lung cancer with HER2 expression or mutation.
- Mechanism: HER2-targeted antibody-drug conjugate. The trastuzumab component binds specifically to HER2-expressing tumor cells, internalizes into cancer cells and releases cytotoxic payload to induce DNA damage and tumor cell apoptosis.
- Drug class: HER2-targeted antibody-drug conjugate (ADC), injectable anti-tumor prescription biologic medicine.
- Clinical use: Targeted therapy for HER2-positive locally advanced and metastatic non-small cell lung cancer.
| Generic Name | Trastuzumab Rezetecan for Injection |
| Brand Name | AiWeiDa |
| Ingredient | Trastuzumab Rezetecan for Injection |
| Dosage Form | Injection |
| Package | 0.1g*1 vial/box |
| Conditions Treated | HER2-expressing or HER2-mutated locally advanced and metastatic non-small cell lung cancer |
| Taboos | Severe hypersensitivity to trastuzumab rezetecan or ADC excipients; patients with active severe interstitial lung disease; pregnant women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Unreconstituted vials refrigerated at 2°C to 8°C, no freezing, protected from light |
| Manufacturer | ShengDiYa Biopharmaceutical, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250024 |
| Approval Date | May 27, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Weight-based intravenous infusion administered once every 21 days (3-week treatment cycle).
Time: Infusion is completed on Day 1 of each 21-day cycle, continued until disease progression or intolerable toxicity.
Instructions for use: Reconstitute and dilute with normal saline for slow intravenous infusion; pre-medication is recommended to manage infusion reactions, pulmonary function monitoring is mandatory throughout treatment.
Interaction: Concomitant chemotherapy agents may exacerbate myelosuppression; systemic immunosuppressants do not interfere with ADC anti-tumor activity.
Side effects: Neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, and immune-related interstitial lung disease.
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 cancer does Trastuzumab Rezetecan for Injection treat?
It treats locally advanced or metastatic HER2-expressing or HER2-mutated non-small cell lung cancer.
What drug class does Trastuzumab Rezetecan for Injection belong to?
It is a HER2-targeted antibody-drug conjugate (ADC) anti-tumor biologic agent.
What is the standard administration cycle of Trastuzumab Rezetecan for Injection?
Intravenous infusion is given once every 21 days continuously.
What is Trastuzumab Rezetecan for Injection's anti-tumor mechanism?
It precisely targets HER2-positive tumor cells, releases cytotoxic payload and induces cancer cell apoptosis.
AiWeiDa® | Trastuzumab Rezetecan for Injection | Lung Cancer | DengYueRX
INN: Trastuzumab Rezetecan for Injection
Indications: Lung cancer
Dosage Form: Injection
Strength: 0.1g/vial
Low MOQ
WHO-GMP
Worldwide Delivery
Compliance and Regulatory Documents
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