FXI/FXIa inhibitors are emerging as potential upgrades to existing anticoagulants, offering improved safety profiles with reduced bleeding risks, according to a research report by Guosen Securities. The global anticoagulant market exceeds $20 billion, but current therapies still face limitations in balancing efficacy (anti-thrombotic effects) and safety (bleeding risks).
FXI/FXIa inhibitors target the intrinsic coagulation pathway, minimizing interference with hemostasis while preventing thrombotic amplification. No FXI/FXIa inhibitors have been approved yet, but five candidates—including Novartis’ abelacimab, Bayer’s asundexian, and BMS/J&J’s milvexian—are advancing in pivotal trials.
Recent Phase 3 data showed Bayer’s asundexian achieved superiority in stroke secondary prevention, marking the first FXI/FXIa inhibitor to hit primary endpoints in a key trial. However, it failed in stroke prevention for atrial fibrillation patients, and milvexian missed efficacy goals in ACS studies. Despite mixed outcomes, FXI/FXIa inhibitors demonstrate clear safety advantages over DOACs, particularly for high-bleeding-risk populations.
Guosen highlights Hengrui Pharma (600276.SH, 01276) as a standout, with its FXI antibody SHR-2004 leading domestic peers in Phase 3 trials. The firm also suggests monitoring companies developing FXI-targeted siRNA therapies, such as Ribolia’s SR059 and Genuine Biotech’s SRSD107, which show promise for quarterly dosing and superior compliance in chronic conditions.
**Risks**: Potential clinical setbacks, delayed development timelines, overseas expansion challenges, and commercialization hurdles.
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