January 15, 2026SimbayPark Park Enterprise Epigenic Therapeutics, Inc.(hereinafter referred to as "Epigenic"") Announces:EPI-003, an innovative epigenetic regulation therapy developed by Epigenic Therapeutics, Inc., has successfully received clinical trial approval (IND) from the National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B.Previously, the drug had received clinical trial approval from the U.S. Food and Drug Administration (FDA) in December 2025, and Phase I clinical research has been successfully advancing in Australia, New Zealand, and Hong Kong, China.This approval by the NMPA marks a key milestone in the implementation of EPI-003's global multicenter clinical development strategy in mainland China, laying an important foundation for benefiting a broader patient population.Chronic hepatitis B is a liver disease caused by infection with the hepatitis B virus (HBV), which can progress from an asymptomatic stage to cirrhosis, liver failure, or even hepatocellular carcinoma (HCC). The main challenge in curing chronic hepatitis B lies in the long-term persistence of HBV covalently closed circular DNA (cccDNA) and HBV DNA integrated into the host genome in the liver, 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," necessitating long-term or even lifelong medication for patients.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 into liver cells, directly inducing persistent 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 significantly and sustainably reduces hepatitis B surface antigen (HBsAg) and HBV DNA levels, maintaining long-term efficacy after discontinuation of treatment, demonstrating the potential to achieve functional or even complete cure of hepatitis B.Dr. Bao-Hong Zhang, CEO and Co-founder of Epigenic, stated
"EPI-003 has received clinical trial approval from the NMPA, marking another significant milestone in our efforts to advance the global development of this innovative therapy, particularly in serving patients in China. As one of the countries with the heaviest burden of hepatitis B, we look forward to accelerating the verification of EPI-003's safety and efficacy in broader populations through systematic and scientific clinical research conducted in China, bringing breakthrough treatment options to patients in China and around the world as soon as possible."This progress not only further expands the global clinical development landscape of EPI-003 but also reflects the high level of attention and support from Chinese regulatory authorities for innovative epigenetic treatment technologies and their potential in overcoming major chronic infectious diseases. Epigenic Therapeutics, Inc. will continue to advance the global multi-center clinical trial process, contributing technological strength to improve the clinical cure rate of hepatitis B, ultimately benefiting a large number of hepatitis B patients worldwide.
Epigenic Therapeutics, Inc. is a cutting-edge biotechnology company dedicated to treating various diseases through epigenetic regulation and developing the next generation of gene modulation therapies. Founded in 2021 by a group of scientists specializing in gene modulation therapy development and seasoned experts from the pharmaceutical industry, the company has established a robust pipeline with multiple candidate products covering metabolic, cardiovascular, viral hepatitis, ophthalmic, and autoimmune diseases.
Shanghai FT1 Life Science Park (Abbreviation"Simbay Park, Star North · Free Trade Zone No.1") is located in the Waigaoqiao Bonded Area, the core of Shanghai's Pudong New Area Free Trade Zone. It is an innovative service-oriented characteristic industrial park under the Star North Group, focusing on the incubation, cultivation, and transformation of medical enterprises.The park relies on the unique "Free Trade + Bonded" outward-oriented economic regional advantages. By gathering the entire industry chain service resources of CRO+CDMO+CSO+EHS in the biopharmaceutical field, government innovation and entrepreneurship support policies, and numerous well-known investment institutions, it provides enterprises with truly in-depth technical incubation in the medical industry, acting as a steward for the transformation of corporate technological achievements, and is committed to building an international biopharmaceutical industry innovation and entrepreneurship base.
