Shenzhen Salubris Pharmaceuticals Co., Ltd. (hereinafter referred to as “the Company”) recently received the Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA), granting permission to initiate a clinical trial for the Company’s self-developed investigational drug SAL0145 injection (project code: SAL0145) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH)^[1].

SAL0145 is a siRNA drug developed by the Company with independent intellectual property rights. Preclinical studies have shown its potential for treating MASH. If successfully developed and approved for marketing, the drug is expected to provide more patients with a new treatment option, address unmet clinical needs, and further enrich the Company’s innovative product pipeline in the CKM chronic disease therapeutic area.

·About MASH^[2]

Metabolic dysfunction-associated steatohepatitis (MASH) is an advanced form of metabolic dysfunction-associated steatotic liver disease (MASLD), which affects approximately 30% of the global adult population. Without intervention or treatment, MASH can further progress to cirrhosis or even liver cancer, posing a serious threat to patients’ health and lives.

·About siRNA drugs^[3]

Small interfering RNA (siRNA) is typically a short double-stranded RNA composed of base pairs. It acts through the RNA interference (RNAi) mechanism to specifically silence the mRNA of pathogenic target genes at the post-transcriptional level, thereby achieving precision treatment of diseases. siRNA drugs can precisely target disease-causing genes, have the advantages of low risk of drug resistance and long-lasting efficacy, and allow reduced dosing frequency, which greatly improves patient compliance. They are expected to transform traditional treatment paradigms and hold great application potential in the field of chronic diseases.

·About CKM^[4]

In October 2023, the American Heart Association published a presidential advisory on cardiovascular-kidney-metabolic (CKM) syndrome, defining CKM syndrome as a health disorder resulting from the pathophysiological interplay among obesity, diabetes mellitus (DM), chronic kidney disease (CKD), and cardiovascular disease (CVD), and manifesting as a systemic disease.

References

[1] Announcement of Shenzhen Salubris Pharmaceuticals Co., Ltd. on receiving the Clinical Trial Approval Notice for SAL0145

[2] Chinese Society of Hepatology, Chinese Medical Association. Guidelines for the prevention and treatment of metabolic dysfunction-associated (non-alcoholic) fatty liver disease (2024 edition). Chinese Journal of Hepatology, 2024, 32(5): 418-434.

[3] Yu Jiaojiao, et al. New progress in research of small interfering RNA drugs in chronic diseases: from preclinical to clinical. Progress in Pharmaceutical Sciences, 2024, 48(8): 579-591.

[4] Chinese Expert Consensus on Comprehensive Management of Patients with Cardiovascular-Kidney-Metabolic Syndrome

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 company integrating R&D, production, and sales, with a foothold in China and a global vision (Stock Code: 002294). With the mission of “providing outstanding pharmaceutical products for human health,” Salubris focuses on the CKM (cardiovascularkidneymetabolic) chronic disease field, primarily cardiovascular diseases. The company has launched several proprietary products, including hypertension treatments Xinlitan, Fulitan®, Fulian®, and Xinchaotuo; the renal anemia treatment EnnaLuo®; and the type 2 diabetes treatment Xinliting®.

Salubris has established five innovative drug R&D centers globally and three medical device R&D bases, forming innovation platforms covering small molecule chemical drugs, biologics, siRNA and gene editing drugs, and medical devices. The company is dedicated to addressing unmet clinical needs and improving people’s quality of life.