xinjiuning dalnacogene ponparvovec injection hemophilia b 2ml

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.

Specification

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