Prime Highlights:

• Huahui Health’s libevitug becomes the first drug approved in China to treat chronic hepatitis D virus (HDV) infections.
• The antibody blocks HDV and hepatitis B virus (HBV) from entering liver cells, marking a major breakthrough in viral hepatitis treatment.

Key Facts:

• HDV affects around 13 million people worldwide, mostly those already infected with HBV, and increases the risk of severe liver disease and liver cancer.
• China has the highest number of chronic hepatitis B cases in the world, with 75 million people affected, though HDV co-infection remains rare at 0.24% of HBV patients.

Background:

Huahui Health has reached an important milestone in treating viral hepatitis, receiving China’s first approval for a drug that treats chronic hepatitis D virus (HDV) infections. China’s National Medical Products Administration (NMPA) has given conditional approval for Libevitug, a drug that stops both HDV and hepatitis B (HBV) from entering liver cells.

Libevitug targets a specific part of the virus called the PreS1 domain to help prevent liver infection. Right now, treatment options for HDV are very limited. In China, most patients use pegylated interferon alpha, which is not very effective and can cause serious side effects. Globally, the only other approved drug for HDV is Gilead Sciences’ Hepcludex (bulevirtide), which has been approved in Europe but rejected by the US FDA.

HDV only infects people who already have hepatitis B (HBV). HDV affects about 5% of people with chronic hepatitis B, around 13 million worldwide. Having both viruses raises the risk of serious liver disease, cancer, and death. It spreads mainly at birth, through blood, sex, or shared needles.

China has the most people with chronic hepatitis B, with about 75 million cases, or one-third of the world’s total. Even so, HDV co-infection is rare, with only 0.24% of hepatitis B patients testing positive for HDV antibodies.

Beijing-based Huahui Health described the approval as a “groundbreaking achievement in viral hepatitis therapeutics”. The company noted that Libevitug has received breakthrough status from both the NMPA and the US FDA and is currently being tested in international studies in the US, Pakistan, and Mongolia.

According to WHO guidelines, people with chronic HBV should be tested for anti-HDV antibodies to identify those at elevated risk of severe liver complications. The approval of libevitug marks a major advancement in managing hepatitis D in China and across Asia, offering hope to patients who previously had limited options.