Beijing-based biotech company Huahui Health, specializing in viral hepatitis, hepatology, and oncology, has announced that it has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its libevitug (HH-003), an anti-PreS1 human monoclonal antibody (mAb), for the treatment of patients with chronic hepatitis delta virus (HDV) infection.
Hepatitis Delta Virus and Libevitug’s Mechanism
Hepatitis Delta Virus (HDV) is a liver-targeting RNA virus that is dependent on Hepatitis B Virus (HBV) for replication and requires HBV for assembly. HDV infects hepatocytes via the receptor sodium taurocholate co-transporting polypeptide (NTCP). Libevitug is described as the world’s first anti-HBV/HDV neutralizing antibody that specifically targets the pre-S1 domain of the viral large envelope protein. By blocking the binding of HBV and HDV to their receptor NTCP, libevitug prevents the virus from entering hepatocytes and neutralizes HBV/HDV infection.
Significance of the BTD
The FDA’s BTD for libevitug highlights the potential of this anti-PreS1 mAb in addressing the unmet medical need for patients with chronic HDV infection. This designation is expected to expedite the development and review process of libevitug, potentially bringing this innovative treatment to market more rapidly.-Fineline Info & Tech
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