Description
Indication & Scope
HICARA® Ranicabtagene Autoleucel Injection treats relapsed or refractory large B-cell lymphoma in adult patients.
- Mechanism:Autologous CD19-targeted CAR-T cell therapy: patient T cells are genetically modified ex vivo to express chimeric antigen receptor, which recognizes and eliminates CD19-positive malignant B cells after infusion.
- Drug class:Autologous chimeric antigen receptor T cell (CAR-T) immunotherapy.
- Clinical use: Single infusion salvage treatment for adults with relapsed/refractory large B-cell lymphoma after multiple prior treatment regimens.
| Generic Name | Ranicabtagene Autoleucel Injection |
| Brand Name | HICARA |
| Ingredient | Ranicabtagene Autoleucel |
| Dosage Form | Injection |
| Package | 30 ml*1 bag, with a target dose of 2.0 × 10 ^ 6 live CAR+T cells/kg body weight (acceptable range 1.4 × 10 ^ 6~2.1 × 10 ^ 6 live CAR+T cells/kg body weight), and a maximum of 2.2 × 10 ^ 8 live CAR+T cells/dose |
| Conditions Treated | Relapsed large B-cell lymphoma, refractory large B-cell lymphoma in adult patients |
| Taboos | Active untreated central nervous system disease, uncontrolled severe infection, pregnancy, severe pre-existing cytokine release syndrome risk factors |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Ultra-low temperature cryopreservation at -196°C in liquid nitrogen vapor phase, transport under continuous cryogenic conditions |
| Manufacturer | HengRunDaSheng Biotechnology Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250040 |
| Approval Date | Jul 29, 2025 |
| Shelf Life | 12 months |
How to use ?
Recommended Dose: Single fixed-volume autologous cell infusion after lymphodepletion chemotherapy, no repeated infusion.
Time: Complete single intravenous infusion within 30 minutes after finishing lymphodepletion conditioning chemotherapy.
Instructions for use: Collecting patients’ white blood cells through leukapheresis, manufacturing targeted immune cells outside the human body, conducting lymphodepletion chemotherapy to clear the original immune cells, and finishing with a single intravenous infusion of the prepared CAR-T cells.
Interaction: Concurrent immunosuppressants before infusion will reduce CAR-T cell expansion efficacy.
Side effects:
1. Common: cytokine release syndrome, neutropenia, fatigue, fever.
2. Severe: immune effector cell-associated neurotoxicity syndrome (ICANS), prolonged myelosuppression, severe infection.
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 kind of therapy is Ranicabtagene Autoleucel Injection?
Ranicabtagene Autoleucel Injection is an autologous chimeric antigen receptor T cell (CAR-T) immunotherapy.
What patients are suitable for Ranicabtagene Autoleucel Injection this CAR-T treatment?
Adult patients with relapsed or refractory large B-cell lymphoma after multiple prior treatments.
What are the two most common severe immune-related side effects of Ranicabtagene Autoleucel Injection?
They are cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.
What pretreatment is required before CAR-T cell infusion of Ranicabtagene Autoleucel Injection?
Patients need to receive lymphodepletion chemotherapy before single-dose cell infusion.
HICARA® | Ranicabtagene Autoleucel Injection | Large B-Cell Lymphoma | DengYueRX
INN: Ranicabtagene Autoleucel Injection
Indications: Large B-cell lymphoma
Dosage Form: Injection
Strength: 30 ml/bag
