The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has indicated that Huahui Health’s HH-003 is on track to obtain priority review status as a “drug eligible for conditional approval.” This designation is specifically for the treatment of chronic hepatitis D virus (HDV) infection.
Drug Mechanism and Innovation
HH-003 is a potential first-in-class neutralizing antibody that targets the PreS1 region of the hepatitis virus surface envelope protein. It works by specifically binding to the PreS1 region on the surface of hepatitis B virus (HBV)/HDV, blocking the binding of HBV, HDV, and its receptor NTCP. This mechanism prevents the virus from entering liver cells and neutralizes the viral infection.
Previous Recognition and Milestones
The drug previously received breakthrough therapy designation in China in April 2023 for the treatment of chronic HDV infection. This recognition highlights the potential of HH-003 to significantly impact the treatment landscape for hepatitis D patients.-Fineline Info & Tech
