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Ribo Secures Orphan Drug Status for RBD1016

On October 26, 2025, Suzhou Ribo Life Science Co., Ltd. and Ribocure Pharmaceuticals AB (commonly known as Ribo) made a significant announcement, revealing that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) for their promising siRNA therapeutic candidate, RBD1016, aimed at treating Hepatitis Delta Virus (HDV) infections. This milestone marks a critical step forward in the fight against HDV, a condition that presents considerable challenges for affected individuals.

Understanding Orphan Drug Designation

The EMA's orphan drug status is specifically reserved for treatments targeting rare and life-threatening conditions, particularly those that impact fewer than 5 out of every 10,000 individuals within the European Union. Receiving this designation not only enhances the visibility of a drug candidate but also provides substantial regulatory and commercial incentives. This facilitates a quicker transition from research to the marketplace, ultimately benefiting patients who desperately require new therapeutic options.

RBD1016’s Mechanism of Action

RBD1016 is developed utilizing Ribo's advanced siRNA technology, particularly their proprietary GalNAc platform, RiboGalSTARTM. This therapeutic agent has been designed to specifically silence key viral factors integral to the HDV infection process. Currently in phase II clinical trials, RBD1016’s efficacy is being evaluated globally, and the results could pave the way for a new wave of treatment protocols for patients suffering from this challenging condition.

According to Dr. Li-Ming Gan, Co-CEO and global head of Research and Development at Ribo, this achievement underscores their ongoing commitment to addressing critical diseases that currently lack effective treatments. "This classification is a significant regulatory milestone that enhances RBD1016's development and commercial potential," noted Dr. Gan. He emphasized the importance of delivering effective treatment solutions to patients burdened by HDV, a virus for which no effective therapies are currently available.

The Burden of Hepatitis Delta Virus (HDV)

HDV is considered the most severe form of viral hepatitis. It primarily infects individuals who are also positive for the Hepatitis B Virus (HBV), complicating their overall health status. The presence of HDV exacerbates liver complications, amplifying the risks of cirrhosis, liver failure, and hepatocellular carcinoma significantly. It is estimated that between 12 to 20 million people worldwide suffer from HDV, yet the treatment options remain markedly limited, highlighting an urgent need for innovative therapeutic strategies.

Given its severity, HDV often goes undiagnosed and untreated, leading to tragic health outcomes for countless individuals. Therefore, the emergence of targeted therapies such as RBD1016 represents a beacon of hope for both patients and healthcare providers seeking more effective and lasting solutions.

About Ribo Life Science

Suzhou Ribo Life Science Co., Ltd. is at the forefront of RNA interference (RNAi) technology development in China, dedicated to advancing the landscape of oligonucleotide-based medicines. The company has established a comprehensive oligonucleotide therapy platform that integrates all necessary technologies for drug development. Furthermore, Ribo boasts a vast pipeline of siRNA-based treatments, solidifying its position as a leader in this innovative field.

Ribocure Pharmaceuticals AB, located in Gothenburg, Sweden, serves as Ribo’s international research and development hub, focusing on global efforts to bring transformational therapies to market.

For further details on Ribo and its groundbreaking work in biotechnology, visit their websites at www.ribolia.com and www.ribocure.com.

The approval of RBD1016 is not just an achievement for Ribo; it holds the promise of a new future for HDV patients worldwide, reflecting a triumph of innovation and commitment in the face of urgent healthcare challenges.