Ribo Receives Phase I IND Approval for Vortosiran in China, Advancing China-Europe Collaboration in Innovative Thrombosis Prevention Therapies
October 26, 2026 – Suzhou, China
Suzhou Ribo Life Science Co., Ltd. (Ribo, 06938.HK) announced that its lead asset, global first FXI-targeting siRNA drug vortosiran(RBD4059), has received Phase I Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) on October 20, 2026, with stroke prevention in patients with atrial fibrillation as its intended indication.
To date, vortosiran’s Phase IIb clinical trial applications for stroke prevention in atrial fibrillation (SPAF) and venous thromboembolism (VTE) have been filed successively in Europe, with approvals granted sequentially. For this application, vortosiran was successfully included in Center for Drug Evaluation (CDE)’s “Optimized 30-working-day IND review pathway” and was approved smoothly. The Phase I clinical trial in China will generate key pharmacokinetic, pharmacodynamic, and safety data in Chinese population, providing an important basis for dose selection in subsequent clinical development of vortosiran. It will also enable Chinese subjects to participate in international multicenter clinical trials of vortosiran and lay a solid foundation for subsequent Phase III clinical trials in China.
Anders Gabrielsen, CMO of Suzhou Ribo Life Science, stated: “The clinical trial approval for vortosiran in China further establishes China’s position as a key hub in Ribo’s global R&D strategy. Under a coordinated global regulatory filing strategy, clinical development in China and Europe has achieved aligned timelines and data synergy, supporting a unified global development process for the product and efficiently advancing global multicenter clinical trials, regulatory submissions, and commercialization planning. We will accelerate clinical research on vortosiran across multiple indications in China and Europe, striving to bring more precise, longer-acting, and safer siRNA therapeutic options to patients with cardiovascular diseases as soon as possible.”
About vortosiran (RBD4059)
Vortosiran (RBD4059) is the world's first siRNA drug targeting coagulation factor XI (FXI), independently developed by Ribo based on its RiboGalSTARTM liver-targeting platform. By specifically inhibiting factor XI gene expression, it blocks the activation of the intrinsic coagulation pathway, achieving precise anticoagulant and antithrombotic effects. Human genetic evidence indicates that individuals with naturally reduced FXI levels are protected against thrombotic disease without a corresponding increase in spontaneous bleeding risk. Therefore, FXI inhibition is regarded as a highly attractive therapeutic approach with the potential to combine effective thrombosis prevention with an improved safety profile relative to existing anticoagulant therapies. Currently, vortosiran is being evaluated in Phase IIb clinical trials in Europe for two indications: stroke prevention in atrial fibrillation (SPAF) and venous thromboembolism (VTE).
About Ribo
Suzhou Ribo Life Science Co., Ltd. (Ribo, 06938.HK) is a global innovative biopharmaceutical company focused on the research, development and commercialization of small interfering RNA (siRNA) therapeutics. Leveraging its proprietary integrated siRNA technology platform, Ribo has established a differentiated and robust product pipeline targeting major unmet clinical needs in cardiometabolic, hepatic, renal and other therapeutic areas. Committed to original innovation, Ribo is dedicated to delivering revolutionary nucleic acid therapeutic solutions to patients worldwide. For more information, please visit www.ribolia.com.