Libevitug becomes first hepatitis D treatment approved in China
Huahui Health says its antibody-based drug addresses critical clinical gap
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Huahui Health‘s Libevitug has become the first approved treatment for chronic hepatitis D virus (HDV) infection in China.
The country’s National Medical Products Administration (NMPA) conditionally approved the therapy for adults with chronic hepatitis D with or without compensated cirrhosis, when the liver can still function despite the presence of irreversible tissue scarring.
Conditional, or accelerated, approval allows a therapy to be brought to market based on early evidence that it is likely to benefit patients. Full approval is dependent on additional clinical trial data confirming the therapy’s benefits.
“As a groundbreaking advance in viral hepatitis care, [Libevitug] is China’s first approved HDV therapy and a first-in-class antibody for viral hepatitis, addressing a critical clinical gap,” Huahui Health stated in a company press release.
Libevitug received breakthrough therapy designation in US
Libevitug received breakthrough therapy designation from both China’s NMPA and the U.S. Food and Drug Administration, intended to accelerate the development and regulatory review of the therapy. Currently, there are no approved therapies for hepatitis D in the U.S.
Hepatitis refers to inflammation of the liver, which is usually caused by viral infections. The most common form of viral hepatitis is hepatitis B, which affects millions of people worldwide.
The HDV can only infect people who are already infected with the hepatitis B virus (HBV). According to the World Health Organization, about 5% of people with hepatitis B — roughly 12 million people — also have hepatitis D. This dual infection is associated with a heightened risk of life-threatening complications like cirrhosis (irreversible liver scarring) and liver cancer.
Libevitug, previously known as HH-003, is an antibody-based therapy designed to simultaneously target specific proteins on the surface of HBV and HDV, making it harder for the viruses to enter liver cells.
Therapy achieved main goal in clinical trial
Approval of the therapy in China was based mainly on data from a Phase 2 clinical trial, dubbed HH003-204 (NCT05861674), which enrolled more than 100 people with chronic HBV and HDV infections.
All participants were treated for nearly one year with Vemlidy (tenofovir alafenamide), an approved antiviral therapy for hepatitis B. Some patients received only this daily oral treatment, while others were given Libevitug infusions every other week at one of two doses (10 mg/kg or 20 mg/kg).
The study’s main goal was to determine how many participants would achieve a combined response, defined as undetectable or substantially reduced HDV genetic material and normalization of blood levels of alanine aminotransferase (ALT), a liver damage marker.
Results showed that, after about six months, roughly a third of patients given Libevitug — 35% on the higher dose and 32.4% on the lower dose — achieved this combined response, compared with 5% of those on Vemlidy alone. This difference was statistically significant.
Significant differences were also observed after about a year, with 42.5% of those on high-dose Libevitug and 44.1% of those on the low dose achieving a combined response, compared with 5% on standard treatment alone.
Huahui said that, after one year, about 60% of Libevitug-treated participants showed undetectable or substantially reduced HDV genetic material, and about 70% had ALT normalization. The therapy was also associated with reductions in liver stiffness, which is indicative of less liver scarring, according to the company.
Libevitug “is poised to provide a novel and accessible treatment option for hepatitis D patients worldwide,” Huahui stated in the release.
