Description
Indication & Scope
GeRuiNing® Velaglucerase Beta for Injection is used for a long-term enzyme replacement therapy for adult and pediatric patients with Type 1 and Type 3 Gaucher disease.
- Mechanism: Recombinant human glucocerebrosidase enzyme that replaces deficient endogenous lysosomal enzyme, breaks down accumulated glucocerebroside in macrophages and visceral organs to reverse Gaucher disease pathological manifestations.
- Drug class: Recombinant lysosomal enzyme replacement therapy, injectable rare disease prescription biologic medicine.
- Clinical use: Lifelong disease-modifying treatment for Gaucher disease to improve organomegaly, cytopenia and skeletal complications.
| Generic Name | Velaglucerase Beta for Injection |
| Brand Name | GeRuiNing |
| Ingredient | Velaglucerase Beta for Injection |
| Dosage Form | Injection |
| Package | 400U*1 vial/box |
| Conditions Treated | Type 1 and Type 3 Gaucher disease (lysosomal storage disorder) |
| Taboos | Severe anaphylactic hypersensitivity to velaglucerase beta or any formulation excipients |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Unreconstituted vials are refrigerated at 2°C to 8°C; reconstituted diluted infusion solution must be used immediately |
| Manufacturer | KangCheng Biotechnology, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250020 |
| Approval Date | May 13, 2025 |
| Shelf Life | 30 months |
How to use ?
Recommended Dose: Standard starting dose is 60 Units per kilogram of body weight administered every other week via intravenous infusion.
Time: Infusion sessions are scheduled every 14 days for long-term continuous treatment.
Instructions for use: Reconstitute and dilute with normal saline before slow intravenous infusion; premedication can be used to prevent infusion-related allergic reactions.
Interaction: No clinically significant drug-drug interactions identified; caution is needed when combined with other intravenous biologics.
Side effects: Infusion-related fever, rash, headache, fatigue, nausea, and rare severe anaphylactic reactions during infusion.
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 rare disease does Velaglucerase Beta for Injection treat?
It is used for enzyme replacement therapy in Type 1 and Type 3 Gaucher disease.
What is the core mechanism of Velaglucerase Beta for Injection?
It supplements deficient glucocerebrosidase enzyme to decompose accumulated lipid substances in lysosomes.
What is the routine administration frequency of Velaglucerase Beta for Injection?
The standard intravenous infusion is performed once every two weeks.
What infusion-related reactions may occur when using Velaglucerase Beta for Injection?
Transient fever, rash, headache and nausea are common infusion side effects during treatment.
GeRuiNing® | Velaglucerase Beta for Injection | Type I and Type III Gaucher Disease | DengYueRX
INN: Velaglucerase Beta for Injection
Indications: Type I and type III gaucher disease
Dosage Form: Injection
Strength: 400U/vial
