Good News | SBK013 Tablets Receive NMPA Clinical Trial Approval, Ushering in the Future of Antithrombotic Therapy

On March 6, 2025, Shibeikang Biomedical Technology Co., Ltd. (referred to as “SBK”) achieved a major milestone with the approval of its innovative SBK013 tablets. The approval, issued by the National Medical Products Administration (NMPA) under Acceptance No. CXHL2401344 and approval number 2025LP00574, grants SBK013 the green light to enter clinical trials. This approval marks the beginning of a promising journey for the drug in advancing antithrombotic therapy.

SBK013 is a cutting-edge, oral small-molecule Factor XIa inhibitor with a novel chemical structure, heralding a significant breakthrough in the treatment of blood clotting disorders. Its unique mechanism targets the inhibition of Factor XI activity, effectively blocking the intrinsic coagulation pathway and preventing the amplification of the coagulation cascade. As a result, SBK013 demonstrates potent capabilities in preventing the formation of harmful blood clots. Unlike traditional anticoagulants, SBK013 allows the tissue factor pathway to remain intact, reducing the bleeding risk complications during treatment and offering a safer, more effective alternative.

As part of its current R&D strategy, SBK013 is primarily being developed for the prevention of venous and arterial thromboembolic diseases, a group of common and high-risk conditions that involve various thrombosis-prone situations. The successful clinical development and eventual approval of SBK013 could address critical unmet needs in the field, offering patients a more effective solution for the prevention and treatment of thrombotic diseases.

SBK013 tablets not only have strong potential in the domestic market but also show significant promise on the global stage. With the increasing prevalence of cardiovascular and thrombotic diseases, the global demand for anticoagulants continues to rise, with the market already surpassing $20 billion. As a first-in-class, innovative drug (Category 1) with a novel mechanism of action, a unique molecular structure, and distinct advantages, SBK013 is well-positioned to compete with existing anticoagulants in the global market, offering patients more therapeutic options and potentially transforming the landscape of thrombotic disease management.

SBK has made significant strides in cardiovascular drug development, achieving several key breakthroughs. If SBK013 successfully completes its development and receives regulatory approval, it will position SBK as a major player in the global anticoagulant market, accelerating the company’s international expansion in the biopharmaceutical sector. The drug is designed to address critical unmet medical needs by offering safer and more effective treatment options.

Looking ahead, SBK is committed to strengthening its presence in global markets, and promoting the commercialization of more clinically valuable, innovative drugs. The successful development of SBK013 represents a key milestone for SBK in international drug R&D, opening up new possibilities and bringing renewed hope to the global field of antithrombotic therapy.

Founded in 2015, Chengdu Shibeikang Biomedical Technology Co., Ltd. is a research-driven company rooted in China, serving the world and dedicated to differentiated drug innovation. Guided by our mission of “Empowering Better Health Through Inclusive Care and Support”, SBK is committed to the core values of “‘People-centered’, Driven by Change, Innovation at the Core”. Guided by clinical needs, we pursue an innovation-driven strategy with a focus on differentiated R&D. Specializing in cardiovascular, cerebrovascular, and respiratory therapies, we are dedicated to becoming a world leader in the differentiated innovation of novel drugs, developing better medicines to patients and advancing human health.