Description
Indication & Scope
XinJiuNing® Dalnacogene Ponparvovec Injection treats adult patients with moderate to severe Hemophilia B (congenital coagulation factor IX deficiency).
- Mechanism: It is a recombinant adeno-associated virus (AAV) gene therapy vector carrying high-activity Factor IX Padua mutant gene. The vector targets liver hepatocytes to stably express functional coagulation factor IX, permanently replenishing deficient clotting factor and reducing spontaneous bleeding episodes.
- Drug class: In vivo gene therapy drug for rare bleeding disorders, prescription biologic medicine.
- Clinical use: Curative long-term one-time treatment for moderate and severe hemophilia B, replacing lifelong regular factor IX replacement infusion therapy.
| Generic Name | Dalnacogene Ponparvovec Injection |
| Brand Name | XinJiuNing |
| Ingredient | Dalnacogene Ponparvovec Injection |
| Dosage Form | Injection |
| Package | 8.0×10^12 vg(2ml)*1 vial/box |
| Conditions Treated | Moderate and severe congenital factor IX deficiency (Hemophilia B) |
| Taboos | Patients with pre-existing high-titer neutralizing antibodies against AAV vector; patients with severe liver cirrhosis, active hepatitis or severe hepatic impairment; pregnant and breastfeeding women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store frozen at -60°C to -80°C, protected from light and repeated freeze-thaw cycles |
| Manufacturer | XinZhi Pharmaceutical Technology, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250016 |
| Approval Date | Apr 8, 2025 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: Single fixed weight-based intravenous infusion dose administered once in a lifetime.
Time: Complete full infusion within several hours under intensive medical monitoring.
Instructions for use: Administered only via slow intravenous infusion by professional gene therapy medical teams; patients require pre-treatment immunosuppressive therapy to control vector immune response.
Interaction: Systemic immunosuppressants are routinely co-administered during treatment; live vaccines are contraindicated within 1 year after infusion.
Side effects: Transient liver enzyme elevation, mild infusion hypersensitivity reactions, fatigue, headache, and rare long-term liver inflammatory responses.
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 the main clinical indication of Dalnacogene Ponparvovec Injection?
It is used for the treatment of moderate to severe Hemophilia B in adult patients.
What is the drug class of Dalnacogene Ponparvovec Injection?
It is an in vivo gene therapy biologic drug for rare bleeding disorders.
What are the major contraindications for Dalnacogene Ponparvovec Injection?
It is prohibited for patients with high AAV antibody titers, severe liver damage, pregnant women and breastfeeding women.
What are the common adverse reactions after Dalnacogene Ponparvovec Injection infusion?
Transient elevated liver enzymes, mild fatigue, headache and slight hypersensitivity reactions are commonly observed.
XinJiuNing® | Dalnacogene Ponparvovec Injection | Hemophilia B | DengYueRX
INN: Dalnacogene Ponparvovec Injection
Indications: Hemophilia B
Dosage Form: Injection
Strength: 8.0×10^12 vg(2ml)/vial
