Suzhou Ribo Life Science Co., Ltd., a leader in RNA interference (RNAi) technology, and its Swedish subsidiary Ribocure Pharmaceuticals AB, 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 awards ODD status to investigational therapies intended for the treatment of rare, life-threatening, or chronically debilitating diseases affecting no more than five in 10,000 individuals in the European Union. The designation offers regulatory support and commercial incentives to accelerate drug development and access for patients.
RBD1016 is an siRNA-based therapeutic candidate designed to selectively silence viral factors involved in HDV infection. The candidate is currently being evaluated in global Phase II clinical trials.
“This designation marks an important milestone for RBD1016 and underscores its potential to address a significant unmet medical need,” said Dr. Li-Ming Gan, Co-CEO and Global Head of R&D at Ribo. “It also validates our RNAi strategy to develop targeted therapies for severe diseases with limited treatment options.”
Hepatitis D Virus (HDV) is the most severe form of viral hepatitis and occurs only in individuals co-infected with hepatitis B virus (HBV). The co-infection accelerates liver disease progression, increasing the risk of cirrhosis, liver failure, and hepatocellular carcinoma. HDV affects an estimated 12–20 million people globally, with few effective treatment options currently available.
The development of therapies such as RBD1016 represents a promising step toward expanding treatment options for patients with HDV, a population often underdiagnosed and underserved.
Suzhou Ribo Life Science is a pioneer in RNAi technology and the industrialization of oligonucleotide drugs in China. The company has established a vertically integrated oligonucleotide platform encompassing discovery, manufacturing, and development capabilities, supported by a growing siRNA pipeline.
Ribocure Pharmaceuticals AB serves as Ribo’s international R&D hub, based in Gothenburg, Sweden, focusing on the development of RNAi-based therapeutics for global markets.