Recently, Salubris announced that the clinical trial application for SAL0137 tablets—an innovative self-developed small-molecule drug targeting elevated Lipoprotein(a) [Lp(a)]—has been accepted by regulatory authorities[1].
Lipoprotein(a) [Lp(a)] is a unique lipoprotein synthesized by the liver, formed by the covalent linkage of apolipoprotein(a) [apo(a)] to apoB-100 in LDL-like particles via a disulfide bond[2].
In recent years, Lp(a) has been recognized as an independent risk factor for atherosclerotic cardiovascular disease (ASCVD), calcific aortic valve disease (CAVD) and stroke. It is even regarded as a significant contributor to the "residual risk" of ASCVD[2][3][4].
SAL0137 is an oral small-molecule Lp(a) inhibitor that reduces Lp(a) levels by blocking the assembly of Lp(a) through inhibiting the binding between Apo(a) and ApoB-100.
Preclinical studies indicate that SAL0137 holds potential for treating elevated Lp(a). If successfully developed and approved, it is expected to provide a new treatment option for patients, address unmet clinical needs, and further enrich the company’s pipeline of innovative products in the chronic disease areas.
|Regarding Lipoprotein(a) [Lp(a)]
An individual's plasma Lp(a) level is primarily determined by genetics and remains relatively stable throughout life. Therefore, testing should be considered at least once in every adult's lifetime.
Screening for Lp(a) should be performed in the following high-risk populations: individuals at very high risk of ASCVD, those with a family history of premature ASCVD (male <55 years, female <65 years), first-degree relatives with elevated serum Lp(a) levels >90 mg/dL (200 nmol/L), patients with familial hypercholesterolemia or other inherited dyslipidemias, and those with calcific aortic valve stenosis.
Lp(a) levels exceeding 30 mg/dL indicate an increased likelihood of cardiovascular disease risk. Since Lp(a) concentrations are predominantly genetically determined, they are minimally influenced by environmental or lifestyle factors. Currently, there remains a lack of effective approved therapies specifically for reducing Lp(a) levels.
References:
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on the Acceptance of the Clinical Trial Application for Drug SAL0137.
[2] Boffa M B, Koschinsky M L. Lipoprotein(a) and cardiovascular disease. Biochemical Journal. 2024;481(19):20. DOI:10.1042/BCJ20240037.
[3] Yang X N, Jia H Y. Research progress on the relationship between lipoprotein(a) and atherosclerotic cardiovascular disease. Chinese Journal of Difficult and Complicated Cases. 2025(8).
[4] Liu Y L, Zhang D Y. Research progress on the correlation between lipoprotein(a) and calcific aortic valve disease. Modern Medicine and Health. 2024;40(16):2826-2830.
[5] Beijing Heart Society. Expert Scientific Advice on the Relationship Between Lipoprotein(a) and Cardiovascular Disease Risk and Clinical Management. Chinese Circulation Journal. 2021;36(12):1158-1167.
Disclaimer:
This material is intended to provide knowledge in the field of disease, enhance disease awareness, and is not for promotional purposes.
The information contained herein is for reference only. Please follow the advice or guidance of physicians or other healthcare professionals.
|About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation-driven pharmaceutical listed company (Stock Code: 002294) with integrated R&D, production, and marketing operations, rooted in China and serving the global market. With the mission of "providing exceptional pharmaceutical products for human health," Salubris has deepened its expertise in chronic disease treatment with a focus on cardiovascular and cerebrovascular conditions. The company has successfully commercialized alisartan monotherapy, combination drugs, and co-crystal formulations to address diverse complex hypertension challenges, establishing a unique family of first-in-class antihypertensive therapies centered on alisartan.
Salubris has established five innovative drug R&D centers and three medical device R&D bases globally, creating innovation platforms focused on small molecule drugs, biological drugs, siRNA therapeutics, gene-editing therapies, and medical devices. The company is committed to developing innovative products that address unmet clinical needs, with the goal of enhancing people's quality of life and extending healthy lifespan.