Epigenic Therapeutics Receives NMPA Clearance of IND Application for Clinical Studies of EPI-003 in Patients with Chronic Hepatitis B Infection

Epigenic Therapeutics (“Epigenic”), a clinical-stage biotechnology company, today announced that the National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for EPI-003, a first-in-class epigenetic regulator for treatment of chronic hepatitis B virus (HBV) infection. This follows the company’s receipt of IND clearance from the U.S. Food and Drug Administration (FDA) in December 2025.

EPI-003 is already in Phase 1 trials across New Zealand, Australia, and Hong Kong SAR. The NMPA clearance marks a critical step in advancing EPI-003's global multi-center clinical development strategy into mainland China and lays a solid foundation for expanding patient access to this potential therapy.

“The NMPA clearance represents another significant milestone in advancing EPI-003 globally, particularly for patients in China, which carries one of the highest burdens of hepatitis B worldwide,” said Bob Zhang, CEO and Co-founder of Epigenic. “We are committed to accelerating the validation of EPI-003's safety and efficacy in broader populations through rigorous clinical research in China, with the goal of delivering a breakthrough treatment option to patients in China and around the world as soon as possible.”