Description
Indication & Scope
Voyxact (sibeprenlimab) contains sibeprenlimab, a humanized monoclonal antibody for the treatment of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN).
- Mechanism: Targets and neutralizes APRIL (A Proliferation-Inducing Ligand), thereby reducing the production of galactose-deficient IgA1 (Gd-IgA1), suppressing pathogenic immune complex formation, and mitigating kidney inflammation and injury.
- Drug class: APRIL blocker; humanized IgG2 monoclonal antibody.
- Clinical use: Reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. The recommended dosage is 400 mg administered by subcutaneous injection once every 4 weeks.
| Generic Name | Sibeprenlimab |
| Brand Name | Voyxact® |
| Ingredient | Each prefilled syringe contains 400 mg of sibeprenlimab in 2 mL (200 mg/mL). |
| Dosage Form | Solution for Subcutaneous Injection. |
| Package | One prefilled syringe (2 mL). |
| Conditions Treated | Reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. |
| Taboos | No contraindications are listed in the approved prescribing information. |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store refrigerated at 2°C–8°C. Do not freeze. Protect from light. Refer to the approved prescribing information for complete storage instructions. |
| Manufacturer | Otsuka Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | XZXK-2026-10101 |
| Date of Revision | 2026 |
| Shelf Life | Refer to the approved package labeling |
How to use ?
Recommended Dose: 400 mg administered by subcutaneous injection once every 4 weeks.
Time: Administer according to the approved dosing schedule. Continue treatment as clinically appropriate.
Instructions for use: Administer by subcutaneous injection using the prefilled syringe. Allow the syringe to reach room temperature before administration. Do not shake. Rotate injection sites if needed.
Interaction: No clinically significant drug interactions have been identified.
Side effects: Upper respiratory tract infection, coronavirus infection, headache, injection-site reactions, and herpes viral 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, indication, 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 Voyxact (sibeprenlimab)?
Voyxact contains sibeprenlimab, a humanized monoclonal antibody targeting APRIL (A Proliferation-Inducing Ligand). It is used to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.
What is the mechanism of action of Sibeprenlimab?
Sibeprenlimab binds to APRIL and blocks APRIL-mediated signaling through its receptors, including BCMA and TACI. This reduces the production of galactose-deficient IgA1 (Gd-IgA1), a key factor involved in IgA nephropathy pathogenesis.
What is the recommended dose of Voyxact?
The recommended dose is 400 mg administered by subcutaneous injection once every 4 weeks.
What are the common adverse reactions of Sibeprenlimab?
Reported adverse reactions include upper respiratory tract infection, coronavirus infection, headache, injection-site reactions, and herpes viral infection.
YiZaiKe® Voyxact | Sibeprenlimab | Primary IgA Nephropathy (IgAN) | DengYueRX
INN: Sibeprenlimab
Indications: Reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN).
Dosage Form: Solution for Subcutaneous Injection
Strength: 400 mg/2 mL
