Guoxin Securities: FXI inhibitors are expected to become the next generation of anticoagulants. It is recommended to focus on Hengrui Pharmaceutical (600276.SH)

The Zhitong Finance App learned that Guoxin Securities released a research report saying that the global anticoagulant market is over 20 billion US dollars. While preventing blood clots, existing anticoagulants pose an additional risk of bleeding; there is still room for improvement in the effectiveness (antithrombotic ability) and safety (reducing the risk of bleeding) of anticoagulants. FXI/FXia is expected to be an upgrade and supplement to existing anticoagulants, with a potential market space of more than 10 billion US dollars. It is recommended to focus on Hengrui Pharmaceutical (600276.SH, 01276): FXI monoclonal antibody SHR-2004 entered phase 3 clinical trials, leading the way among domestic molecules; and pay attention to companies with FXI small nucleic acid drug pipelines.

Guoxin Securities's main views are as follows:

FXI/FXia inhibitors are expected to become safer anticoagulants

Existing anticoagulants all act on the common pathway of blood clotting. FXI is only involved in endogenous coagulation pathways and positive feedback amplification of blood clots, and inhibiting FXI activity is expected to reduce the risk of bleeding while anticoagulating. Currently, no FXI/FXia inhibitors have been approved for marketing. Various drug forms such as targeted antibodies, small molecules, and small nucleic acids are in the clinical stage. Among them, 5 candidate molecules, including Novartis abelacimab, Bayer's asundexian, and BMS/Johnson's Milvexian, are undergoing registered clinical trials. FXI/FXia inhibitors have demonstrated better safety in multiple indications.

FXI/FXia inhibitors challenge standard treatment in multiple indications

Recently, Bayer's asundexian achieved excellent results in phase 3 clinical trials for secondary stroke prevention, becoming the first FXI/FXia inhibitor to reach key clinical endpoints. Previously, asundexian did not reach the end of efficacy in the phase 3 clinical trial of stroke prevention in patients with atrial fibrillation, and milvexian was also not effective compared to placebo in ACS patients. According to available clinical data, FXI/fxia inhibitors show significant safety advantages over DOACS and may have a competitive advantage in patients with a high risk of bleeding. On the other hand, in indications where endogenous coagulation pathways predominate, FXI/FXia inhibitors are also expected to be covered.

FXI micronucleic acid drugs may have a differentiated competitive advantage

FXI's small nucleic acid drugs are still in the early stages of development. Ruibo Biotech's SR059 and Jingyin Pharmaceutical's SRSD107 are undergoing phase 2 clinical studies. Early PK/PD data showed that FXI siRNA drugs efficiently inhibit FXI activity and may be able to achieve the Q3M injection cycle, which can bring an advantage of compliance for chronic disease medication.

Risk warning: Risk of clinical results falling short of expectations, risk of clinical progress falling short of expectations, risk of overseas development falling short of expectations, risk of commercialization falling short of expectations.