Description
Indication & Scope
AiZeLi® is a prescription PD-L1/TGF-β bifunctional fusion protein indicated, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with PD-L1-positive (CPS ≥1) locally advanced unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma.Retlirafusp alfa simultaneously targets the PD-L1 and TGF-β pathways to enhance antitumor immune responses.
- Mechanism: Retlirafusp alfa is an IgG4-TGF-βRII extracellular domain fusion protein that binds PD-L1 while trapping TGF-β1 and TGF-β3, reducing immunosuppression and promoting CD8⁺ T-cell infiltration into the tumor microenvironment.
- Drug class: PD-L1/TGF-β bifunctional fusion protein.
- Clinical use: First-line treatment of PD-L1-positive locally advanced unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma in combination with chemotherapy.
| Generic Name | Retlirafusp Alfa Injection |
| Brand Name | AiZeLi® |
| Ingredient | Retlirafusp alfa |
| Dosage Form | Injection |
| Package | 300 mg/6 mL per vial |
| Conditions Treated | PD-L1-positive locally advanced unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma |
| Taboos | Hypersensitivity to retlirafusp alfa or any component of the product; active autoimmune disease |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Refer to the approved package labeling. |
| Manufacturer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20260002 |
| Date of Revision | 2026 |
| Shelf Life | Refer to the approved package labeling. |
How to use ?
Recommended Dose: The recommended dose is 30 mg/kg or a fixed dose of 1,800 mg administered by intravenous infusion once every 3 weeks.
Time: Infuse over 90 minutes. If well tolerated, subsequent infusions may be shortened to 60 minutes.
Instructions for use: Administer by intravenous infusion before chemotherapy, allowing at least 30 minutes between completion of Retlirafusp alfa infusion and initiation of chemotherapy. Continue maintenance monotherapy until disease progression or unacceptable toxicity.
Interaction: Retlirafusp alfa is not metabolized by CYP450 enzymes and has no known clinically significant metabolic interactions with chemotherapy agents.
Side effects: Common adverse reactions include fatigue, anemia, leukopenia, neutropenia, nausea, diarrhea, decreased appetite, infusion-related reactions, and immune-mediated adverse events such as pneumonitis, hepatitis, and thyroid disorders.
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 AiZeLi® used for?
It is indicated, in combination with chemotherapy, as first-line treatment for adult patients with PD-L1-positive (CPS ≥1) locally advanced unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma.
How does Retlirafusp alfa work?
It blocks PD-L1-mediated immune suppression while neutralizing TGF-β1 and TGF-β3, enhancing antitumor immune activity.
How is AiZeLi® administered?
It is administered by intravenous infusion once every three weeks before chemotherapy.
Can AiZeLi® be used alone?
It is used in combination with chemotherapy for first-line treatment and may be continued as maintenance monotherapy after chemotherapy according to the approved prescribing information.
AiZeLi® | Retlirafusp Alfa | Gastric Cancer | DengYueRX
INN: Retlirafusp alfa
Indications: Advanced gastric or gastroesophageal junction adenocarcinoma
Dosage Form: Injection
Strength: 300 mg/6 mL
