Epigenic Therapeutics' Epigenetic Therapy EPI-003 Receives FDA IND Clearance, Marking a Breakthrough in Chronic Hepatitis B Treatment

December 19, 2025, Epigenic Therapeutics, Inc.(UpperSea）Biotechnology Co., Ltd.(hereinafter referred to as "Epigenic")Today announced: Its innovative epigenetic regulation therapy EPI-003 has officially received approval from the U.S. Food and Drug Administration.（FDA）Clinical Trial Permit（IND）, for the treatment of chronic hepatitis B. EPI-003 is the world's first FDA-approved lipid nanoparticle-based drug to enter clinical trials.（LNP）Epigenetic Regulation Therapy via Delivery Technology. Currently, the Phase I clinical trial of the drug is proceeding smoothly in New Zealand, Australia, and Hong Kong. The recent FDA approval will significantly advance the global multicenter clinical development process of EPI-003.

Chronic hepatitis B is caused by the hepatitis B virus（HBV）Infections can lead to liver diseases, progressing from an asymptomatic stage to cirrhosis, liver failure, or even hepatocellular carcinoma.（HCC）. The main challenge in curing chronic hepatitis B is HBV covalently closed circular DNA（cccDNA）HBV DNA integrates into genomic DNA and persists in the liver for a long time, leading to the continuous expression of viral surface antigens. Current antiviral drug treatments for hepatitis B can only suppress HBV replication but are unable to eradicate these "viral reservoirs," requiring patients to take medication long-term or even for life.

EPI-003 is an intravenous antiviral drug based on a novel mechanism of action. The drug utilizes an LNP delivery system to precisely deliver mRNA encoding epigenetic regulatory proteins and guide RNA targeting HBV genes to liver cells, directly inducing lasting epigenetic modifications on cccDNA and integrated DNA, thereby suppressing the production of all viral products at the transcription source. Preclinical studies have shown that EPI-003 can significantly and persistently reduce hepatitis B surface antigen.（HBsAg）And HBV DNA levels, maintaining long-term efficacy after discontinuation of the drug, showing the potential to achieve functional cure or even complete cure of hepatitis B.

Dr. Bao-Hong Zhang, co-founder and CEO of Epigenic Therapeutics, Inc., stated: "The FDA's approval for the clinical trial of EPI-003 marks a key milestone in its global development pathway. This is not only the first epigenetic regulation therapy based on LNP delivery to be approved by the FDA, but it also represents substantial progress in our efforts to leverage cutting-edge technology to address the challenge of chronic hepatitis B. We will fully advance clinical research with the hope of bringing a transformative treatment option to hundreds of millions of patients worldwide as soon as possible."

This progress is not only a milestone for the innovative therapy EPI-003 but also marks a new exploration phase for epigenetic regulation technology in tackling major chronic viral infections.

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