Core Insights - Suzhou Ribobio Technology Co., Ltd. and its subsidiary Ribocure Pharmaceuticals AB announced that the European Medicines Agency (EMA) granted orphan drug designation for their siRNA candidate drug RBD1016, aimed at treating hepatitis D virus (HDV) infection [1][2] Group 1: Orphan Drug Designation - The orphan drug designation by EMA is intended to encourage therapies for rare diseases with a prevalence of less than 5 in 10,000, which pose a serious threat to life or cause chronic debilitating conditions [1] - This designation provides innovative drugs with better regulatory pathways and commercialization incentives, allowing for faster patient access [1] Group 2: Clinical Development - RBD1016 is being developed using Ribobio's proprietary RiboGalSTARTM liver-targeted delivery platform, which has demonstrated safety, efficacy, and long-lasting effects through multiple clinical studies [1] - The drug is currently advancing through Phase II clinical trials for both hepatitis B and D globally [1] Group 3: Company Statements - The co-CEO and Global R&D President of Ribobio stated that the orphan drug designation is a significant milestone for RBD1016, enhancing its development and commercialization prospects [2] - The company is committed to advancing the clinical research of RBD1016 to provide new treatment options for patients suffering from this rare disease [2]