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HEPA44 is a therapeutic synthetic peptide vaccine developed by Tasly Biopharma for the treatment of chronic Hepatitis B. It is a water-insoluble polypeptide composed of 44 artificially designed linear peptides derived from Hepatitis B virus (HBV) protein sequences. Designed using an epitope-based approach, it incorporates various immune response epitopes from different HBV antigens. Clinical trials in China (Phase I and II) have demonstrated high HBeAg serological conversion rates, a favorable safety profile, and long-term persistence without viral rebound or drug resistance. Tasly Biopharma is currently pursuing an Investigational New Drug (IND) application with the FDA to initiate clinical trials in the United States.
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