huayounuo libevitug injection hdv 6ml 300mg

Description

Indication & Scope

HuaYouNuo® Libevitug Injection serves as long-term subcutaneous injection treatment for adult patients with chronic hepatitis D virus (HDV) infection, with or without compensated liver cirrhosis.

Mechanism: Anti-sodium taurocholate cotransporting polypeptide (NTCP) neutralizing monoclonal antibody. It binds with high specificity to the NTCP receptor expressed on hepatocyte surface, blocks HDV virion attachment and internalization into liver cells, interrupts complete HDV viral replication cycle and reduces intrahepatic viral load to improve hepatic inflammation.
Drug class: Anti-NTCP human monoclonal antibody / Anti-hepatitis D virus antiviral biologic injectable drug.
Clinical use: Single-agent chronic suppressive therapy for chronic HDV-infected adults with compensated liver disease; reduces serum HDV RNA levels, alleviates hepatic necroinflammation and slows progression to decompensated cirrhosis and hepatocellular carcinoma.

Specification

Generic Name	Libevitug Injection
Brand Name	HuaYouNuo
Ingredient	Libevitug
Dosage Form	Injection
Package	300mg(6ml)*1 vial/box
Conditions Treated	Chronic hepatitis D virus (HDV) infection in adult patients with or without compensated liver cirrhosis
Taboos	Severe hypersensitivity to libevitug or antibody formulation excipients; patients with decompensated liver cirrhosis (Child-Pugh B/C); active severe systemic bacterial/viral infection; pregnant and breastfeeding women
Place of origin	China
Prescription type	Prescription-only
Storage Conditions	Sealed prefilled syringes refrigerated continuously at 2°C–8°C, avoid freezing and direct strong light exposure
Manufacturer	Intellective Biotechnology Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	S20260003
Approval Date	Jan 20, 2026
Shelf Life	30 months

How to use ?

Recommended Dose: Standard fixed subcutaneous injection dose of 300 mg, administered once every two weeks (biweekly maintenance dosing).

Time: Biweekly fixed-day subcutaneous injection, self-administered by patients into abdomen or thigh tissue independent of meal timing.

Instructions for use: Rotate subcutaneous injection sites with each biweekly dose; conduct baseline Child-Pugh liver function classification before initiation; monitor serum HDV RNA, liver transaminases and hepatic fibrosis markers every 12 weeks during chronic therapy; avoid live viral vaccines during antibody treatment.

Interaction: Concurrent nucleos(t)ide analog anti-HBV agents deliver additive viral suppression for co-infected HBV/HDV patients without amplified adverse risk; systemic immunosuppressants may reduce libevitug’s antiviral potency by suppressing endogenous antibody activity.

Side effects: Common mild adverse reactions: injection site redness, pruritus, headache, transient mild ALT flare, fatigue, arthralgia. Rare severe risks: systemic hypersensitivity anaphylaxis, severe persistent hepatic transaminase elevation, secondary bacterial infection at injection sites.

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

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What hepatocyte surface receptor does Libevitug Injection neutralize to block hepatitis D virion entry into liver cells?

It binds and inhibits the sodium taurocholate cotransporting polypeptide (NTCP), the sole host receptor for HDV cellular uptake.

What stage of chronic liver disease in HDV patients excludes them from receiving Libevitug Injection therapy?

Decompensated liver cirrhosis classified as Child-Pugh B or C hepatic dysfunction.

What two core clinical biomarkers require quarterly monitoring to assess Libevitug Injection antiviral therapeutic response?

Circulating serum HDV RNA viral load and hepatic ALT transaminase inflammation levels.

Why does Libevitug Injection provide complementary antiviral activity when co-administered with standard nucleoside analog HBV treatments for co-infected patients?

Nucleos(t)ide analogs suppress HBV genome replication, while libevitug exclusively blocks HDV host cell entry, generating dual viral suppression in HBV/HDV co-infected individuals.