Recently, Salubris announced that the clinical trial application for its self-developed innovative siRNA drug, SAL0195 Injection (project code: SAL0195), has been approved, allowing the initiation of clinical studies for the treatment of elevated lipoprotein(a) [Lp(a)].[1]
Elevated lipoprotein(a) [Lp(a)] is an independent risk factor for coronary heart disease, ischemic stroke, peripheral vascular disease, coronary artery calcification, and calcific aortic valve stenosis. Through multiple mechanisms, including the promotion of atherosclerosis, inflammation, and thrombosis, elevated Lp(a) significantly increases the risk of cardiovascular diseases.[2]. SAL0195 is a highly potent and highly specific small interfering RNA (siRNA) therapeutic designed to target lipid metabolism pathways. In preclinical studies using non-human primate models, SAL0195 demonstrated a long-acting target-silencing effect, with a single administration maintaining target knockdown for up to 140 days.[1]
If successfully developed and approved for marketing, SAL0195 is expected to provide a new treatment option for patients with elevated Lp(a), addressing currently unmet clinical needs. It would also further enrich the company's innovative product pipeline in the field of cardiovascular-kidney-metabolic (CKM) syndrome, with a strategic focus on cardiovascular and cerebrovascular diseases.
About siRNA Therapeutics[3]
Small interfering RNA (siRNA) consists of short double-stranded RNA molecules, typically composed of complementary base pairs. Through the RNA interference (RNAi) mechanism, siRNA specifically silences disease-causing target messenger RNA (mRNA) at the post-transcriptional level, thereby enabling precise treatment of diseases.
siRNA therapeutics can accurately target pathogenic genes while offering advantages such as a low likelihood of drug resistance and long-lasting therapeutic effects. Their prolonged duration of action allows for less frequent dosing, which can substantially improve patient adherence to treatment. As a result, siRNA drugs have the potential to transform conventional therapeutic approaches and hold significant promise for the treatment of chronic diseases.
References：
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on SAL0195 Receiving Approval for Clinical Trials.
[2] Beijing Heart Society. Expert Scientific Recommendations on the Relationship Between Lipoprotein(a) and Cardiovascular Disease Risk and Its Clinical Management. Chinese Circulation Journal. 2021;36(12):1158-1167.
[3] Yu Jiaojiao, et al. Recent Advances in Small Interfering RNA (siRNA) Therapeutics for Chronic Diseases: From Preclinical Research to Clinical Development. Progress in Pharmaceutical Sciences. 2024;48(8):579-591.
|About Salubris
Salubris is an innovative,international pharmaceutical company that integrates R&D,manufacturing,and sales.We remain committed to the mission of"providing excellent pharmaceutical products for human health"and focus on the chronic disease area of cardiovascular-kidney-metabolic(CKM) syndrome,safeguarding life and health.Our marketed novel drugs include Xinlitan®(for hypertension),XinchaoTuo®(for hypertension),Fulitan®and Fuli'an®(for hypertension),Ennaluo® (for renal anemia),and Xinliting®(for type 2 diabetes mellitus).
Globally,Salubris has established five innovative drug R&D centers and three medical device R&D bases.It has also built innovation platforms covering small molecules,peptides/cyclic peptides,antibody-based biologics,siRNA oligonucleotides,in vivo gene editing,AIDD(AI-driven drug discovery),and medical devices,all aimed at addressing unmet clinical needs.
