Description
Indication & Scope
HuaYouNuo® (Libevitug) is a prescription human monoclonal antibody indicated for the treatment of adult patients with chronic hepatitis D virus (HDV) infection with or without compensated cirrhosis (Child-Pugh Class A). Libevitug specifically targets the Pre-S1 domain of the HBV/HDV envelope protein, blocking viral entry into hepatocytes through the NTCP receptor and helping reduce HDV infection.
- Mechanism: Libevitug specifically binds to the Pre-S1 region of the HBV/HDV envelope protein, preventing viral attachment to the NTCP receptor on hepatocytes and inhibiting viral entry. It also promotes immune-mediated clearance of infected liver cells.
- Drug class: Human monoclonal antibody.
- Clinical use: Treatment of adult patients with chronic hepatitis D virus (HDV) infection with or without compensated cirrhosis.
| Generic Name | Libevitug Injection |
| Brand Name | HuaYouNuo® |
| Ingredient | Libevitug |
| Dosage Form | Injection |
| Package | 300 mg/6 mL per vial |
| Conditions Treated | Chronic hepatitis D virus (HDV) infection with or without compensated cirrhosis |
| Taboos | Hypersensitivity to Libevitug or any component of the product; decompensated cirrhosis (Child-Pugh B or C); HIV infection; active tuberculosis |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Refer to the approved package labeling. |
| Manufacturer | Huahui Angen Biopharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20260003 |
| Date of Revision | 2026 |
| Shelf Life | Refer to the approved package labeling. |
How to use ?
Recommended Dose: The recommended dose is 10 mg/kg administered by intravenous infusion once every 2 weeks. The dose may be increased to 20 mg/kg every 2 weeks based on clinical evaluation.
Time: Administer by intravenous infusion over 30–60 minutes.
Instructions for use: Dilute only with 0.9% sodium chloride injection. Do not administer by IV push or mix with other medicinal products. Infuse within 1 hour after preparation and discard any unused solution.
Interaction: Libevitug is not metabolized by CYP450 enzymes and has no known clinically significant interactions with nucleos(t)ide analogues used for HBV treatment.
Side effects: Common adverse reactions include infusion-related reactions, fatigue, arthralgia, and transient ALT elevation. Rash and insomnia may occur occasionally.
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 HuaYouNuo®?
HuaYouNuo® is a human monoclonal antibody developed for the treatment of chronic hepatitis D virus (HDV) infection.
What is HuaYouNuo® used for?
It is indicated for adults with chronic HDV infection with or without compensated cirrhosis.
How does it work?
Blocks the interaction between the viral Pre-S1 protein and the NTCP receptor, preventing HDV from entering liver cells.
Can HuaYouNuo® be used in patients without HBV surface antigen (HBsAg)?
No. HDV requires HBsAg for replication, and Libevitug is intended for HBsAg-positive patients with chronic HDV infection.
HuaYouNuo® | Libevitug | Chronic HDV | DengYueRX
INN: Libevitug
Indications: Chronic hepatitis D virus (HDV) infection
Dosage Form: Injection
Strength: 300 mg/6 mL
