Epigenic Therapeutics has received investigational new drug (IND) approval from its China homeland's National Medical Products Administration for EPI-003, an innovative epigenetic regulation therapy for chronic hepatitis B (CHB). This marks the first clinical approval in China for an epigenetic editing therapy for this indication. The candidate had previously received IND clearance in the US in December 2025 and is already progressing in Phase I studies in Australia, New Zealand and Hong Kong.

EPI-003 employs a lipid nanoparticle (LNP) delivery system to transport mRNA encoding an epigenetic regulator and a guide RNA targeting the hepatitis B virus (HBV) genome in liver cells. The therapy is designed to induce lasting epigenetic modifications to both covalently closed circular DNA (cccDNA) and integrated HBV DNA, aiming to suppress all viral products at the transcriptional source. Preclinical studies have demonstrated significant and sustained reductions in hepatitis B surface antigen and HBV DNA levels, with potential for a functional cure. The approval for trials in China, a country with a high disease burden, accelerates the development of this novel treatment approach.

PharmCube's NextBiopharm® database lists 57 epigenome editing therapies under active development worldwide, including six in human trials. Click here to request a free trial for NextBiopharm®.