Sirius Therapeutics' Class 1 Lipid-Lowering Nucleic Acid Drug SRSD216 Granted IND Approval in China

Mar 20, 2025 16:44 CST Updated 16:44

Sirius Therapeutics

Oligonucleotide Drug Developer

▎WuXi AppTec Content Team Report

Today (March 20),The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA),Sirius Therapeutics' Application for the New Class 1 Drug SRSD216 Injection Approved for Clinical Trials, Development PlannedTreatmentLipoprotein(a)[Adult patients with elevated Lp(a) levels to reduce the risk of atherosclerotic cardiovascular disease (ASCVD). Public information shows that SRSD216 is aA New Generation of siRNA Therapy for Treating Hyperlipoproteinemia (a). This is the first time that the product has been approved for an IND in China.

Screenshot source:CDE Official Website

Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of death worldwide. Dyslipidemia is considered a key factor in the development of ASCVD. Although low-density lipoprotein cholesterol (LDL-C) has always been regarded as the primary lipid indicator and intervention target for ASCVD, numerous studies have shown,Lp(a) is an independent risk factor for ASCVD and is not influenced by age, diet, or exercise.Currently, the lipid-lowering drugs available have limited effect on reducing Lp(a), and there is a significant unmet clinical need for drugs that directly target Lp(a).

According to the previous press release from Sirius Therapeutics, SRSD216 Injection is aNovel double-stranded small interfering ribonucleic acid (siRNA)。It specifically modulatesLPAGenes, reducing liver Apo(a) production and lowering Lp(a) levels in circulation.Preclinical in vivo studies have shown that,After a single dose, Lp(a) levels were reduced by nearly 100%, with the effect lasting over six months.No meaningful safety events were observed.

Public information shows that Sirius Therapeutics, a clinical-stage biotechnology company, focuses on the global development of next-generation nucleic acid innovative therapies in the field of cardiometabolic diseases. Sirius Therapeutics has cumulatively received nearly 100 million US dollars in financing from OrbiMed, Hongyuan Capital, Hanco Capital, and Prosperity Investment. The company's products currently in the clinical development stage include SRSD107 for the treatment of thromboembolic diseases and SRSD101 for the treatment of dyslipidemia.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Mar 20，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[[2] Sirius Therapeutics' Another siRNA Therapy Clinical Trial Application Accepted by China's NMPA. Retrieved Dec 31，2024. From https://mp.weixin.qq.com/s/AEjn8X99SVujPVuvg4FOdQ

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