Sirius Therapeutics Announces China NMPA Approval for Human Clinical Trial of SRSD101, a siRNA Therapeutic for Dyslipidemia

November 15, 2023, San Diego and Shanghai - Sirius Therapeutics today announced that China National Medical Products Administration (NMPA) approved the Investigational New Drug (IND) application of SRSD101 for dyslipidemia. "We are pleased with the approval made by NMPA. This demonstrated our translational capability of clinical development, and the commitment to build-up of our cardiovascular disease franchise.” said Dr. Qunsheng Ji, Sirius Therapeutics Chief Executive Officer.

About Cardiovascular Diseases

Cardiovascular disease (CVD) is the leading cause of death worldwide, resulting in over 17 million deaths annually ^[1]. Elevated low-density lipoprotein cholesterol (LDL-C) is a major risk factor for the development of CVD. For every 1 mmol/L (38.7 mg/dL) change in LDL-C, the relative risk for CVD increase by more than 20% ^[2].

Statins, the backbones of lowering LDL-C, are the primary and secondary prevention of CVDs. However, due to statins’ poor adherence and/or intolerance, about 50% of patients failed achieving the guideline-recommended LDL-C target levels ^[3,4].

About SRSD101

SRSD101 is a novel double-stranded small interfering ribonucleic acid (siRNA). Developed by Sirius Therapeutics, SRSD101 specifically targets Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) mRNA to inhibit PCSK9 protein production, and subsequently increases LDL-C receptors, thereby lowing LDL-C in the circulation. The pronounced durability of pharmacology and safety profile exhibited in preclinical studies suggested SRSD101 has potential to be a new-generation therapeutic for dyslipidemia.

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

Reference:

1. Cardiovascular diseases (CVDs) - World Health Organization (WHO).

https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-%28cvds%29

2. Sabatine, Marc S., et al. Efficacy and Safety of Further Lowering of Low-Density Lipoprotein Cholesterol in Patients Starting With Very Low Levels: A Meta-analysis. JAMA Cardiol. 2018 Sep 1;3(9):823-828.

3. Mann DM, Woodward M, Muntner P, Falzon L, and Kronish I. Mann Predictors of Nonadherence to Statins: A Systematic Review and Meta-Analysis. Ann Pharmacother. 2010;44:1410-21.

4. Poluzzi, E., Strahinja, P., Lanzoni, M. et al. Adherence to statin therapy and patients’ cardiovascular risk: a pharmacoepidemiological study in Italy. Eur J Clin Pharmacol 64, 425–432 (2008).