Huahui Health announced that China’s National Medical Products Administration (NMPA) has granted conditional approval for libevitug, a first‑in‑class antibody targeting the PreS1 region of hepatitis B and D viruses, for the treatment of chronic hepatitis D virus (HDV) infection in adults with or without compensated cirrhosis. The approval marks the world’s first antibody‑based therapy for HDV and China’s first treatment for this disease.
Regulatory Milestone
Item
Detail
Company
Huahui Health (China‑based)
Drug
Libevitug (anti‑PreS1 antibody)
Approval Type
Conditional marketing authorization
Agency
NMPA (China)
Indication
Chronic hepatitis D virus (HDV) infection in adults (with/without compensated cirrhosis)
Firsts
World’s first antibody‑based HDV drug; China’s first HDV treatment
Clinical Program
6‑year development; pivotal study HH003‑204 presented as Late‑Breaking at AASLD 2025
Approval Date
20 Jan 2026
Drug Profile & Mechanism of Action
Target:PreS1 region of hepatitis B surface antigen (HBsAg), blocking viral entry into hepatocytes and inhibiting both HBV and HDV replication
Mechanism: Monoclonal antibody that neutralizes viral particles and prevents attachment to hepatocyte receptors, reducing viral load and liver inflammation
Innovation: First antibody to target the entry step of HDV lifecycle, offering a direct antiviral mechanism distinct from interferon‑based therapies
Administration: Subcutaneous injection (dosing regimen per label)
Clinical Evidence – Pivotal Study HH003‑204
Endpoint (Week 48)
Libevitug Response Rate
Clinical Significance
Composite Response (virological + biochemical)
44.1 %
Primary endpoint; superior to control
HDV Virological Suppression
60 %
Significant viral load reduction
ALT Normalization
70 %
Marker of reduced liver inflammation
Liver Stiffness Improvement
Significant and sustained
Indicates reduced fibrosis progression
Safety Profile
Favorable tolerability; excellent safety
No new safety signals identified
Study Design: Pivotal regulatory trial demonstrating superiority over control group across all core efficacy endpoints
Clinical Benefit: Sustained virological suppression and biochemical improvement with manageable safety profile
Unmet Need: HDV is the most severe form of chronic viral hepatitis with highest risk of cirrhosis and hepatocellular carcinoma; existing interferon therapies achieve <30 % sustained virological response with poor tolerability
Differentiation: Libevitug offers targeted antibody therapy with superior efficacy (44‑60 % response rates) and better safety vs. interferon
Global Expansion: Conditional approval supports rolling submission to FDA and EMA; orphan drug designation expected given prevalence
Strategic Positioning
Manufacturing: Huahui’s Shanghai biologics facility (capacity 20,000 L) will produce libevitug for China market; partnership discussions underway for global supply
Commercial Launch: Targeting tier‑3 hepatology centers initially; NRDL negotiation planned for 2027 to expand access
Pipeline Synergy: Validates PreS1 antibody platform for potential HBV functional cure combinations (with siRNA or capsid inhibitors)
Regulatory Pathway: Conditional approval requires post‑marketing confirmatory study; full approval expected upon completion of 96‑week data
Forward‑Looking Statements This brief contains forward‑looking statements regarding commercial launch timelines, global regulatory submissions, and market penetration for libevitug. Actual results may differ due to competitive responses, pricing negotiations, and post‑marketing study outcomes.-Fineline Info & Tech
By Fineline Cube 