BEIJING, China & GOTHENBURG, Sweden — 2025-10-24 — Suzhou Ribo Life Science Co., Ltd. and Ribocure Pharmaceuticals AB (Ribo), today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to RBD1016 for the treatment of Hepatitis D Virus (HDV) infection.
The EMA’s ODD is assigned to investigational therapies of life-threatening or chronically debilitating rare diseases that affect no more than five in 10,000 individuals in the European Union. The ODD status provides significant regulatory and commercial incentives, thus enabling more rapid progression to patients. Ribos siRNA platform with the proprietary GalNAc-platform RiboGalSTARTM, has currently been validated with a number of clinical studies. RBD1016 is one of the programs, where the siRNA drug candidate is designed to selectively silence key viral factors involved in HDV infection. Efficacy of RBD1016 is currently being assessed in global Phase II clinical development. “This designation is a significant regulatory milestone that enhances the development and commercial potential of RBD1016” says Dr. Li-Ming Gan, Co-CEO and Global Head of R&D at Ribo. “It validates our strategy of targeting severe diseases with high unmet need through innovative RNA interference technology. We are advancing this promising therapy through clinical development, with the goal of delivering a new treatment to patients affected by this rare disease. Most importantly, it represents hope for HDV patients who lack effective treatment options.”
About Hepatitis D Virus (HDV)
HDV is the most severe form of viral hepatitis and occurs only in individuals co-infected with hepatitis B virus (HBV). HDV accelerates liver disease progression, significantly increasing the risk of cirrhosis, liver failure, and hepatocellular carcinoma. It is estimated that 12–20 million people globally are affected by HDV, with limited therapeutic options currently available.
Despite its severity, HDV remains underdiagnosed and underserved. The development of targeted therapies like RBD1016 offers a promising path forward for patients and clinicians seeking more effective and durable treatment options.
