Ruibo Bio-B (06938): FIC's new small nucleic acid anticoagulant drug adds another major new certificate, reshaping the treatment pattern and leveraging the $10 billion racetrack

The average maximum decrease in FXI activity reached 92%, the FXI inhibition level continued for several months, and maintained excellent safety performance... Phase IIa data for the core product vortosiran (RBD4059), first released by Ruibo Bio-B (06938) at the CPIC conference, once again verified the remarkable characteristics of the drug's “potent, long-lasting, and safe”.

Differentiated anticoagulation solutions have added another major new certificate, showing the innovative value of FIC source

As the world's first FXI siRNA drug for the treatment of thrombotic diseases with the fastest clinical development, vortosiran was developed based on the RibogalStar™ liver targeting technology platform independently developed by Ruibo Biotech. It can achieve precise anticoagulant and antithrombotic effects by specifically inhibiting FXI expression and blocking the activation of endogenous coagulation pathways.

Data from this phase IIa clinical study on coronary artery disease (CAD) indications showed that in terms of efficacy, the average maximum decrease in FXI activity reached 92% in patients who completed a high-dose course of administration with a maintenance dose of 400 mg, and continued for several months after administration. This data supports the potential dosing regimen for vortosiran every 3 to 6 months in different indications.

In terms of safety, the study results showed that vortosiran was safe: in the phase IIa clinical trial, there were no serious treatment-related adverse events, major bleeding events, or clinically relevant non-major bleeding events.

Compared with drugs currently being developed with the same target, vortosiran has shown significant advantages. The suppression of FXI activity is significantly higher than the level currently estimated for small-molecule drugs currently in phase III clinical development and usually administered once or twice a day.

Notably, the above results provided the world's first FXI siRNA clinical concept validation in patients with coronary artery disease, supporting vortosiran's development potential as a differentiated, long-lasting antithrombotic therapy. By targeting FXI, vortosiran reduces the risk of thrombosis while retaining the body's hemostatic function, which is expected to solve major unmet medical needs in the field of cardiovascular disease, and further verify the innovative value of Vortosiran's FIC source in reshaping the global anticoagulant treatment pattern.

The sword points to the immediate need for global anticoagulants, leveraging the 10 billion dollar racetrack

According to the Zhitong Finance App, antiplatelet and anticoagulant treatment is already routine clinical treatment at this stage, but the risk of thrombotic events is still not fully controlled in patients with stable coronary artery disease (CAD) after standard optimization treatment. The high risk of bleeding is a major limitation of existing treatments, which further constrains the intensity of treatment and long-term medication plans for many patients.

The current phase IIa clinical results of Vortosiran have proven that it can effectively address the current antithrombotic treatment difficulties in CAD treatment, control bleeding risk while achieving efficient and long-term prevention of thromboembolism, and achieve treatment results that balance curative efficacy and safety.

From a market perspective, about 1/4 of global deaths are related to thrombotic diseases every year. The global antithrombotic drug market will reach 70 billion US dollars in 2026, and is expected to exceed 100 billion US dollars in 2031. Of this, about 55% to 60% of the shares may become the target market for siRNA therapy targeting FXI, so there is a huge unmet market demand.

The sword points to the global market for precise anticoagulants and antithrombotic agents, and Ruibo Biotech already has a long-term strategic layout.

According to the latest R&D progress, Ruibo Biotech has continuously submitted two phase IIb clinical applications for atrial fibrillation stroke prevention (SPAF) and venous thromboembolism (VTE) to the European EMA in the 2nd quarter of this year. These milestones mark a critical breakthrough in the clinical development of small nucleic acid drugs in the field of global anticoagulant treatment.

The Zhitong Finance App learned that in selecting clinical development strategies for the anticoagulant treatment market, Ruibo Biotech not only launched a “saturation attack” with multiple indications based on vortosiran, but also established a “combo punch” plan. For example, in May of this year, Ruibo Biotech submitted a phase II clinical trial application (CTA) for RBD1119, a small nucleic acid drug used to treat CAD to the EMA. This fully demonstrates Ruibo Biotech's differentiated development strategy and strong determination to conquer the cardiovascular field. Its world-leading anticoagulant/antithrombotic micronucleic acid layout is clearly visible.

The subsequent reading of key data and potential approval of the company's many major anticoagulant drugs will also become a decisive verification point for the collaborative efforts of the Ruibatuo product matrix, leveraging the $10 billion global anticoagulant circuit and consolidating its leading position in FIC.