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Salubris, today announced that its self-developed innovative drug, SAL0112, was approved by NMPA for phase 1 trial for Type 2 Diabetes Mellitus (T2DM).

SAL0112 tablet is an orally dosed small-molecule biased agonist of glucagon-like peptide-1 receptor (GLP-1R), its intended indications include Type 2 Diabetes Mellitus (T2DM) and weight management in adults with obesity or overweight.

SAL0112 tablet, as an oral GLP-1R biased agonist, has similar pharmacological effects to the polypeptide GLP-1RA.  At present, the GLP-1RAs currently marketed in China are all peptide injections, of which long-term frequent administration may lead to problems such as poor patient compliance.

SAL0112 tablet is for oral administration. If SAL0112 is approved for marketing after a series of clinical trials, it will effectively improve the route of administration of type 2 diabetes, facilitate the convenience of medication for patients, and enhance medication compliance.

Relevant information

Activating GLP-1R can promote the proliferation of islet β cells, stimulate the synthesis and release of insulin in a blood sugar-dependent manner,  inhibit the synthesis and release of glucagon, and result in a lower risk of hypoglycemia; Activating GLP-1R can also inhibit gastric secretion and gastrointestinal motility, delays gastric emptying, increases satiety, and reduces food intake. In addition, activating GLP-1R can improve cardiovascular function, inhibit the apoptosis of cardiomyocytes, the oxidative stress, inflammatory response of the kidney, and the end products of glycation, thereby protect the kidneys. Therefore, GLP-1R agonists can be used in type 2 diabetes and obesity with concomitant cardio-renal benefits.

The Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition) point out that T2DM patients with atherosclerotic cardiovascular disease (ASCVD) or high cardiovascular risk, regardless of whether their HbA1c reached the standard or not, as long as there are no contraindications, can benefit from using the combination of Metformin and GLP-1R agonists with evidence of ASCVD

In the consensus of "Chinese Expert Recommendations on Clinical Application of Novel Antihyperglycemic Drugs to Improve Cardiovascular and Renal Outcomes", it is pointed out that GLP-1RA can significantly reduce the risk of cardiovascular and renal clinical outcomes, the incidence of stroke and myocardial infarction and improve the quality of life in patients with T2DM and ASCVD diagnosis or high risk.