RiboCure and RiboBio Announce EMA Orphan Drug Designation for siRNA Candidate RBD1016 in Hepatitis D Virus Infection

Suzhou Ribo Life Science Co., Ltd. ("Ribo Life Science") and its subsidiary Ribocure Pharmaceuticals AB ("Ribocure") jointly announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to their small interfering RNA (siRNA) candidate drug RBD1016 for the treatment of Hepatitis D Virus (HDV) infection.

The EMA's Orphan Drug Designation aims to encourage the development of therapies for rare diseases with an incidence rate lower than 5 in 10,000 in the EU, which pose a serious threat to life or result in chronic debilitating conditions. The orphan drug designation provides innovative medicines with an optimized regulatory pathway and commercialization incentives, enabling them to benefit patients more quickly. The safety, efficacy, and long-lasting effects of Ribo Life Science's self-developed RiboGalSTARTM liver-targeting delivery platform have been validated through multiple clinical studies, including RBD1016 for the treatment of HDV indications. This drug is currently advancing in Phase II clinical trials for hepatitis B and D worldwide.

Dr. Gan Liming, Co-CEO and Global R&D President of Ribo Life Science, stated: "This orphan drug designation is a significant milestone in the development of RBD1016, which will greatly enhance the development and commercial prospects of RBD1016. It validates our strategy of addressing severe diseases with high unmet clinical needs through innovative RNAi technology. We are fully committed to advancing the clinical research of this drug, aiming to provide a new treatment option for patients suffering from this rare disease. We are very pleased to see that RBD1016 brings hope to HDV patients who currently have no effective treatment options."