YiJie LiKe Announces China's First Epigenetic Editing Therapy EPI-003 Granted IND Approval for Chronic Hepatitis B Treatment

1Month15DayEpigenic Therapeutics, Inc. announced its innovative epigenetic regulation therapyEPI-003Has successfully obtained the approval from the National Medical Products Administration (NMPA) Clinical Trial Approval (IND）, used for the treatment of chronic hepatitis B. Previously, the drug had already been2025Year12Month Obtained in the United StatesFDAClinical Trial Permit（FDAThe first approval for clinical use based onLNPDelivery of Epigenetic Therapies), and has been successfully advancing in Australia, New Zealand, and Hong Kong, China.IPhase Clinical Study.

Chronic hepatitis B is caused by the hepatitis B virus (HBV) Infections leading to liver diseases, which can progress from an asymptomatic stage to liver cirrhosis, liver failure, or even hepatocellular carcinoma (HCC). The main challenge in curing chronic hepatitis B isHBVCovalently Closed CircularDNA（cccDNA) and integration into the genomeDNAinHBV DNAPersisting 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 suppressHBVreplication but cannot eradicate these "viral reservoirs," requiring patients to take medication long-term or even for life.  

EPI-003It is an intravenous antiviral drug based on a novel mechanism of action. The drugThroughLNPDelivery system encoding epigenetic regulatory proteinsmRNATargetedHBVGene GuidanceRNAPrecise Delivery to Liver Cells，Directly tocccDNAAnd IntegrationDNAPerform Persistent Epigenetic Modifications, thereby suppressing the generation of all viral products at the transcription source.

Preclinical studies have shown,EPI-003Can significantly and continuously reduce hepatitis B surface antigen (HBsAg) andHBV DNAlevels, and maintain long-term efficacy after discontinuation,Demonstrates the potential to achieve functional cure and even complete cure of hepatitis B.

Epigenic was founded in2021Year, dedicated to treating various diseases through epigenetic regulation, the company has now developed multiple pipeline candidate products, covering metabolism, cardiovascular, viral hepatitis, ophthalmology, oncology, and rare diseases.

Co-founder of the company,CEODr. Zhang Baohong said: "China is one of the countries with the heaviest burden of hepatitis B, looking forward to accelerating validation.EPI-003The safety and efficacy in broader populations, to bring breakthrough treatment options to patients in China and even globally as soon as possible.”

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