Description
Indication & Scope
HICARA® is a prescription CD19-directed autologous chimeric antigen receptor (CAR) T-cell therapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
- Mechanism: Ranicabtagene autoleucel is an autologous CD19-directed CAR T-cell therapy manufactured from a patient’s own T lymphocytes genetically modified to express a chimeric antigen receptor targeting CD19. Following infusion, CAR T cells recognize and eliminate CD19-positive malignant B cells through targeted immune-mediated cytotoxicity.
- Drug class: CD19-directed autologous CAR T-cell therapy.
- Clinical use: Treatment of adult patients with relapsed or refractory large B-cell lymphoma following at least two prior lines of systemic therapy.
| Generic Name | Ranicabtagene Autoleucel Injection |
| Brand Name | HICARA® |
| Ingredient | Ranicabtagene Autoleucel |
| Dosage Form | Injection |
| Package | 30 mL/bag |
| Conditions Treated | Relapsed or refractory large B-cell lymphoma (LBCL) |
| Taboos | Hypersensitivity to any component of the product; uncontrolled active infection; patients unable to tolerate lymphodepleting chemotherapy |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store and transport in the vapor phase of liquid nitrogen. Do not refreeze after thawing. |
| Manufacturer | Shanghai Hengrunda Biotechnology Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250040 |
| Date of Revision | 2025 |
| Shelf Life | Refer to the approved package labeling. |
How to use ?
Recommended Dose: The recommended target dose is The recommended target dose is 2.0 × 10⁶ CAR-positive viable T cells/kg administered as a single intravenous infusion following lymphodepleting chemotherapy. following lymphodepleting chemotherapy.
Time: The product should be infused as soon as possible after thawing according to institutional procedures.
Instructions for use: HICARA® is an autologous, patient-specific cell therapy intended for one-time intravenous administration only. Treatment must be performed at qualified medical centers under the supervision of physicians experienced in CAR T-cell therapy. Patients should receive lymphodepleting chemotherapy before infusion and be closely monitored for cytokine release syndrome (CRS), neurologic toxicities, and infections after treatment.
Interaction: Avoid the use of systemic immunosuppressive agents, including high-dose corticosteroids, before CAR T-cell expansion unless required for the management of treatment-related toxicities. Supportive care medications may be administered according to institutional guidelines.
Side effects: Common adverse reactions include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), neutropenia, anemia, thrombocytopenia, pyrexia, fatigue, decreased appetite, and infections.
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 HICARA® used for?
HICARA® is indicated for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
How does Ranicabtagene Autoleucel work?
It is a CD19-directed autologous CAR T-cell therapy that genetically modifies a patient’s own T cells to recognize and destroy CD19-positive B-cell lymphoma cells.
How is HICARA® administered?
HICARA® is administered as a one-time intravenous infusion after lymphodepleting chemotherapy in qualified treatment centers.
What are the major risks associated with HICARA®?
The major risks include cytokine release syndrome (CRS), neurologic toxicity (ICANS), infections, and prolonged cytopenias.
HICARA® | Ranicabtagene Autoleucel | Relapsed or Refractory Large B-Cell Lymphoma | DengYueRX
INN: Ranicabtagene Autoleucel
Indications: Relapsed or refractory large B-cell lymphoma (LBCL)
Dosage Form: Injection
Strength: 30 mL/Bag
