By Fineline Cube 
Suzhou Ribo Life Science Co., Ltd. and its subsidiary Ribocure Pharmaceuticals AB announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to their small‑interfering RNA (siRNA) candidate RBD1016 for the treatment of Hepatitis Delta Virus (HDV) infection.
Why RBD1016 Is a Game‑Changer
- First‑in‑class siRNA therapy for a life‑threatening, chronically debilitating viral infection.
- RiboGalSTAR – a proprietary, liver‑targeting delivery platform that has demonstrated superior safety, efficacy, and long‑acting pharmacokinetics across multiple clinical studies.
- Phase II Momentum – RBD1016 is now advancing in global Phase II trials for both Hepatitis B and Hepatitis D, positioning the company to address a major unmet need in viral hepatology.
EMA Orphan Drug Designation
| Feature | Detail |
|---|---|
| Indication | Hepatitis Delta Virus (HDV) |
| Designated Status | Orphan Drug Designation (ODD) |
| Prevalence Threshold | < 5 per 10,000 EU residents |
| Benefits | 7‑year market exclusivity, protocol assistance, and potential fee waivers for clinical trials in the EU. |
RiboLife’s RiboGalSTAR Platform
- Targeted Delivery – Optimized for hepatocyte uptake, reducing off‑target exposure.
- Clinical Validation – Proven safety and efficacy in early‑phase studies for both HBV and HDV.
- Manufacturing Readiness – Scalable GMP production pipeline established in Suzhou and across Europe.
Next Steps
- Phase II Global Trials – Continue enrollment in HBV and HDV cohorts, aiming for data read‑out in Q1 2026.
- Regulatory Strategy – Leverage EMA ODD status to streamline submissions across the EU and pursue parallel filings in the U.S. and Japan.
- Commercial Planning – Engage with payers and patient groups to facilitate rapid access upon regulatory approval.
Forward‑Looking Statement
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech