January 15, 2026 — Epigenic Therapeutics (Shanghai) Co., Ltd. ("Epigenic"), a clinical-stage biotech company focused on innovative drug discovery and development, announced that its novel epigenetic regulation therapy, EPI‑003, has received Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B (CHB).

This milestone follows EPI‑003's earlier IND clearance from the U.S. Food and Drug Administration (FDA) in December 2025. Phase I clinical studies are already underway in Australia, New Zealand, and Hong Kong SAR. The NMPA approval marks a critical step forward in EPI‑003’s global multicenter clinical development strategy and establishes a solid foundation to bring this innovative therapy to patients in mainland China.

Addressing the Unmet Need in Chronic Hepatitis B

Chronic hepatitis B is a liver disease caused by hepatitis B virus (HBV) infection. It can progress from an asymptomatic state to cirrhosis, liver failure, and hepatocellular carcinoma (HCC). A major barrier to curing chronic HBV infection is the long-term persistence of covalently closed circular DNA (cccDNA) and HBV DNA integrated into the host genome, which continuously drive viral antigen expression in hepatocytes.

Current antiviral therapies can effectively suppress HBV replication but cannot eliminate these persistent viral reservoirs, leaving many patients on lifelong treatment. 

EPI-003: A Novel Epigenetic Approach to HBV Cure

EPI‑003 is a first‑in‑class, intravenously administered antiviral therapy with a new mechanism of action. Using an advanced lipid nanoparticle (LNP) delivery system, the therapy delivers mRNA encoding epigenetic regulatory proteins along with guide RNAs targeting HBV genes directly into hepatocytes.

This approach enables durable epigenetic modification of both cccDNA and integrated HBV DNA, suppressing viral transcription at its source—thereby inhibiting the production of all viral proteins and replication intermediates.

Preclinical studies have shown that EPI‑003 significantly and sustainably reduces hepatitis B surface antigen (HBsAg) and HBV DNA levels, with long‑lasting antiviral effects even after treatment discontinuation. These findings highlight the therapy’s potential to achieve functional—and possibly complete—cure of chronic hepatitis B.

Advancing Global Clinical Development

This latest regulatory clearance further expands the global clinical footprint of EPI‑003 and reflects strong support and recognition from Chinese regulatory authorities for innovative epigenetic therapies targeting major chronic infectious diseases.

Epigenic will continue advancing its global multicenter clinical development program to improve cure rates for chronic hepatitis B and ultimately benefit patients worldwide.

Enorna: Empowering Innovation Through mRNA-LNP CRDMO Excellence

Enorna is honored to support the CMC development and manufacturing of the EPI-003 program through our integrated mRNA and LNP CRDMO platform capabilities. We extend our sincere congratulations to Epigenic on achieving NMPA IND clearance for this breakthrough therapeutic candidate—an important milestone in accelerating its global multicenter clinical development.

We look forward to continuing our collaboration and helping bring new hope for curative HBV therapies to patients around the world.