Description
Indication & Scope
AiZeLi® Retlirafusp Alfa Injection provides single-agent intravenous immunotherapy for adult patients with locally advanced unresectable, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma progressing after at least one prior line of systemic chemotherapy.
- Mechanism: Dual-target bifunctional fusion protein simultaneously targeting TGF-β and PD-L1. It binds tumor-expressed PD-L1 to reverse cancer-mediated T-cell immune exhaustion, while neutralizing tumor-secreted transforming growth factor beta to block the immunosuppressive tumor microenvironment; restores endogenous anti-tumor cytotoxic T cell activity against gastric malignant cells.
- Drug class: Dual PD-L1/TGF-β trap bifunctional fusion protein / Immune checkpoint inhibitor immunotherapy for gastrointestinal malignancies.
- Clinical use: Second-line or later salvage immunotherapy for metastatic gastroesophageal adenocarcinoma; single-agent treatment for patients ineligible for combination chemotherapy after first-line treatment failure.
| Generic Name | Retlirafusp Alfa Injection |
| Brand Name | AiZeLi |
| Ingredient | Retlirafusp Alfa |
| Dosage Form | Injection |
| Package | 300mg(6ml)*1 vial/box |
| Conditions Treated | Locally advanced unresectable, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma in adults |
| Taboos | Severe hypersensitivity to retlirafusp alfa or formulation excipients; active uncontrolled severe autoimmune disease; active untreated interstitial lung disease; patients receiving concurrent live attenuated vaccines |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Unreconstituted lyophilized vials refrigerated at 2°C–8°C, protected from light; discard reconstituted diluted infusion solution within 24 hours if refrigerated, do not freeze |
| Manufacturer | ShengDiYa Biopharmaceutical, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20260002 |
| Approval Date | Jan 5, 2026 |
| Shelf Life | 30 months |
How to use ?
Recommended Dose: Standard fixed intravenous infusion dose of 1200 mg per treatment cycle, administered once every 14 days (2-week infusion intervals).
Time: Complete intravenous infusion over 60 minutes every two weeks; pre-medicate with antihistamines and corticosteroids before each infusion to mitigate infusion hypersensitivity reactions.
Instructions for use: Reconstitute lyophilized powder with sterile water for injection, further dilute into normal saline infusion bags; pause or slow infusion rate for acute hypersensitivity symptoms; screen baseline autoimmune and pulmonary function before treatment initiation; permanently discontinue for grade ≥3 immune-related adverse events unresponsive to high-dose steroids.
Interaction: Concurrent systemic corticosteroids before cycle 1 blunt anti-tumor immune activation efficacy; other immune checkpoint inhibitors increase severe immune-related adverse event risk significantly. Live vaccines are contraindicated during active retlirafusp alfa therapy.
Side effects:
1. Common immune-mediated adverse reactions: fatigue, hypothyroidism, rash, infusion-related fever, mild diarrhea.
2. Severe grade ≥3 immune toxicities: immune pneumonitis, autoimmune colitis, endocrine organ dysfunction, severe infusion anaphylaxis.
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 two immunosuppressive molecular pathways does Retlirafusp Alfa Injection simultaneously block as a bifunctional fusion protein?
Retlirafusp Alfa Injection inhibits PD-L1 immune checkpoint signaling and neutralizes tumor-derived TGF-β immunosuppressive cytokine activity.
What primary gastrointestinal malignant tumor type is Retlirafusp Alfa Injection retlirafusp alfa approved to treat in adult patients?
Unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma.
What mandatory pre-infusion medications are administered before every two-week Retlirafusp Alfa Injection intravenous treatment?
Prophylactic antihistamines and systemic corticosteroids to prevent acute infusion-related hypersensitivity reactions.
What major therapeutic advantage distinguishes Retlirafusp Alfa Injection from single-agent PD-L1 monoclonal antibodies for gastroesophageal cancer?
Its dual mechanism reverses two independent tumor immune escape pathways (PD-L1 T-cell suppression and TGF-β microenvironment immune silencing) for improved anti-tumor response rates.
AiZeLi® | Retlirafusp Alfa Injection | Adenocarcinoma | DengYueRX
INN: Retlirafusp Alfa Injection
Indications: Adenocarcinoma of stomach and gastroesophageal junction
Dosage Form: Injection
Strength: 300mg(6ml)/vial
Low MOQ
WHO-GMP
Worldwide Delivery
Compliance and Regulatory Documents
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