Suzhou Ribo Life Science Co., Ltd. submitted the IIb clinical trial application for vortosiran, the world's first new siRNA drug targeting FXI, for atrial fibrillation-Suzhou Ribo Life Science Co., Ltd. Technology Co., Ltd.
April 14, 2026·Suzhou, China Mölndal, Sweden
Suzhou Ribo Life Science Co., Ltd. (6938.HK) and its subsidiary Ribocure Pharmaceuticals (collectively known as "Suzhou Ribo Life Science Co., Ltd.") announced today that the world's first siRNA drug vortosiran (RBD4059) independently developed by the company to target coagulation factor XI (FXI) has successfully submitted a Phase IIb clinical trial application (CTA) for stroke prevention (SPAF) in patients with atrial fibrillation. This marks a milestone breakthrough in the global clinical development of small nucleic acid (siRNA) drugs in the field of anticoagulation therapy.
By achieving precise and lasting inhibition of FXI, vortosiran intervenes in the FXI-mediated coagulation pathway, achieving efficient protection against thromboembolism while significantly reducing the risk of bleeding. Compared with existing anticoagulant treatments, vortosiran can reduce the risk of bleeding while improving clinical benefits for patients.
Suzhou Ribo Life Science Co., Ltd. has planned to conduct phase IIb clinical studies covering a variety of thrombosis and cardiovascular indications, and the clinical trial code-named ORBIT-XI-AF submitted this time is one of them. With the completion of the Phase IIa trial of vortosiran for coronary artery disease (CAD), this application will further consolidate and strengthen the product's leading position as the world's fastest FXI-targeted small nucleic acid drug.
"The successful submission of this clinical trial application is a landmark breakthrough for Suzhou Ribo Life Science Co., Ltd. and for patients around the world who lack the best anticoagulant treatment options," said Dr. Anders Gabrielsen, chief medical officer of Suzhou Ribo Life Science Co., Ltd., "As FXI As a pioneer in the field of targeted siRNA therapy, we are accelerating the clinical development of vortosiran to address the huge unmet medical needs in the field of stroke prevention in patients with atrial fibrillation. This milestone fully validates the strength of the company's siRNA technology platform and further consolidates our leading position in the field of next-generation anticoagulation therapy."