Sirius Therapeutics Announces China NMPA Approval for Human Clinical Trial of SRSD107, a Long-Acting Next-Generation Anticoagulant for Thromboembolic Disorders

March 5, 2024, San Diego and Shanghai - Sirius Therapeutics today announced that China National Medical Products Administration (NMPA) approved the Investigational New Drug (IND) application of SRSD107 for the prevention and treatment of thromboembolic disorders. Currently SRSD107 phase-1 study is being conducted in Australia.

“We are pleased with the approval made by NMPA. This will further accelerate our global development of SRSD107, which has the first-in-class potential,” said Dr. Qunsheng Ji, Sirius Therapeutics Chief Executive Officer.

About Thromboembolic Disorders

Thrombosis is the common underlying mechanism of most cases of myocardial infarction, ischemic stroke, and venous thromboembolism (VTE). According to a study in The Lancet of reginal and global mortality, thromboembolic disorders are estimated to cause 1 in 4 deaths worldwide¹.

About SRSD107

SRSD107 is a novel double-stranded small interfering ribonucleic acid (siRNA). Developed by Sirius Therapeutics, SRSD107 specifically targets coagulation factor XI (FXI) mRNA and inhibits FXI protein expression, thereby blocking the intrinsic coagulation pathway and promoting anticoagulant/anti-thrombotic effects. Preclinical in vivo studies demonstrated near 100% reduction of FXI levels for up to 6 months, without bleeding events after a single subcutaneous dose.

About Sirius Therapeutics

Sirius is an innovative biotech company developing next generation siRNA therapy for global markets. We are dedicated to discovering and developing new treatment options for cardiovascular disease patients.

Founded in 2021 by a world-class leadership team and investors, Sirius has established an innovative discovery center in the United States and translational medicine center in China. Sirius has raised nearly US$100 million funding to date from OrbiMed, Creacion Ventures, Hankang Capital, Delos Capital, and the leadership team.

Reference:

[1] Lozano R, Naghavi M, Foreman K, et al. Lancet. 2012;380, 2095-1128.

For more information, please visit to the website www.siriusrna.com.