Epigenic Therapeutics (Shanghai) Biotechnology Co., Ltd., a clinical‑stage biotech focused on epigenetic modulation therapies, announced that EPI-003, the world’s first epigenetic regulatory therapy based on lipid nanoparticle (LNP) delivery, received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis B. The drug is currently in Phase 1 trials in New Zealand, Australia, and Hong Kong SAR.
Regulatory Milestone
Item
Details
Approval Date
19 Dec 2025
Agency
U.S. FDA
Product
EPI‑003
Innovation
World’s first LNP‑delivered epigenetic regulatory therapy
Phase 1 trials underway in New Zealand, Australia, Hong Kong SAR
Drug Profile & Differentiation
Attribute
EPI‑003
Competitive Landscape
Technology
LNP‑delivered mRNA encoding epigenetic regulators
Novel approach vs. nucleoside analogs and siRNAs
Mechanism
Direct epigenetic silencing of cccDNA/integrated DNA
Addresses viral reservoir, not just replication
Preclinical Efficacy
Significant and sustained reduction in HBsAg and HBV DNA
Maintains efficacy post‑treatment discontinuation
Clinical Potential
Functional cure and potential complete cure
Current therapies rarely achieve HBsAg loss
Innovation
First epigenetic therapy for HBV globally
Positions Epigenic as leader in viral epigenetics
Market Opportunity
Metric
Value
Context
Global HBV Prevalence
300 million chronically infected (WHO)
870,000 annual deaths from HBV‑related complications
China HBV Market
¥15‑20 billion (≈ US$2.1‑2.8 B)
Dominated by nucleoside analogs (entecavir, tenofovir)
Functional Cure Rate
<5% with current SOC
High unmet need for therapies achieving HBsAg loss
EPI‑003 Peak Sales
¥5‑8 billion (≈ US$700 M‑1.1 B) globally by 2035
If approved, could capture 20‑30% of China HBV market
Competitive Advantage
Epigenetic silencing of viral reservoir
Differentiated from replication‑inhibiting agents
Strategic Implications
For Epigenic Therapeutics:FDA IND approval validates LNP epigenetic platform; first‑in‑class status creates competitive moat; global Phase 1 positions for potential partnering with Big Pharma.
For HBV Treatment:Epigenetic approach addresses cccDNA reservoir, key barrier to cure; sustained HBsAg reduction post‑treatment is unprecedented; offers hope for functional cure without lifelong therapy.
For RNA/epigenetics Market: Demonstrates expansion of RNA therapeutics beyond vaccines and rare diseases into chronic viral infections; LNP delivery to liver cells is validated platform; epigenetic modulation opens new therapeutic space for other viruses (HDV, HCV).
Forward‑Looking Statements This brief contains forward‑looking statements regarding EPI‑003’s clinical development timeline, market potential, and competitive positioning. Actual results may differ due to regulatory feedback, clinical risks, or competitive responses.-Fineline Info & Tech
By Fineline Cube 