Guosen Securities: FXI Inhibitors Poised to Become Next-Generation Anticoagulants; Recommends Focus on Hengrui Medicine (600276.SH)

According to the Zhitong Finance APP, Guoxin Securities released a research report stating that the global anticoagulant drug market size exceeds 20 billion US dollars. Existing anticoagulant drugs, while preventing thrombosis, also bring additional bleeding risks; there is still room for improvement in the efficacy (anti-thrombotic ability) and safety (reducing bleeding risks) of anticoagulant drugs. FXI/FXIa is expected to become an upgrade and supplement to existing anticoagulant drugs, with potential market space exceeding tens of billions of US dollars. It is recommended to pay attention to Hengrui Pharma (600276.SH, 01276): The FXI monoclonal antibody SHR-2004 has entered Phase III clinical trials, leading among domestically produced molecules; also, attention should be paid to companies with FXI small nucleic acid drug pipelines.

The main viewpoints of Guoxin Securities are as follows:

FXI/FXIa Inhibitors Expected to Become Anticoagulants with Better Safety

Existing anticoagulant drugs all act on the common pathway of coagulation. FXI is only involved in the intrinsic coagulation pathway and the positive feedback amplification of thrombosis. Inhibiting FXI activity is expected to reduce the risk of bleeding while exerting anticoagulant effects. Currently, no FXI/FXIa inhibitors have been approved for marketing. Multiple drug modalities, including targeted antibodies, small molecules, and small nucleic acids, are in clinical stages. Among them, five candidate molecules—Novartis' abelacimab, Bayer's asundexian, and BMS/Johnson & Johnson's milvexian—are undergoing registrational clinical trials. FXI/FXIa inhibitors have demonstrated superior safety across multiple indications.

FXI/FXIa Inhibitors Challenge Standard Treatments Across Multiple Indications

Recently, Bayer's asundexian demonstrated superiority in a phase 3 clinical trial for secondary stroke prevention, becoming the first FXI/FXIa inhibitor to reach the primary endpoint in a pivotal clinical study. Previously, asundexian did not meet the efficacy endpoint in a phase 3 trial for stroke prevention in atrial fibrillation patients, and milvexian also failed to show superiority over placebo in ACS patients. Based on current clinical data, FXI/FXIa inhibitors exhibit significant safety advantages compared to DOACs and may hold a competitive edge in patients at high risk of bleeding. Additionally, FXI/FXIa inhibitors are expected to cover indications where the intrinsic coagulation pathway plays a dominant role.

FXI small nucleic acid drugs may have differentiated competitive advantages

FXI siRNA Drugs Still in Early Stages of Development; Ribo Life Science’s SR059 and Sirius Therapeutics’ SRSD107 Are Undergoing Phase 2 Clinical Trials. Early PK/PD Data Shows That FXI siRNA Drugs Efficiently Inhibit FXI Activity and May Achieve a Q3M Injection Regimen, Offering Advantages in Medication Adherence for Chronic Disease Management.

Risk Warning:Risks of clinical outcomes falling short of expectations, risks of clinical progress falling short of expectations, risks of overseas development falling short of expectations, and risks of commercialization falling short of expectations.