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On November 21, 2022, MindRank has formally submitted its self-developed potential "Best" to the US Food and Drug Administration (FDA) after completing its pre-IND communication meeting with the FDA
in
Class "Application for a new drug (IND) for type 2 diabetes mellitus and weight loss indication for non-competitive oral glucagon-like peptide 1 (GLP-1) receptor small molecule agonist MDR-001 was accepted
.
in Class "Application for a new drug (IND) for type 2 diabetes mellitus and weight loss indication for non-competitive oral glucagon-like peptide 1 (GLP-1) receptor small molecule agonist MDR-001 was accepted
.
GLP-1 is a peptide hormone secreted by intestinal cells, which stimulates the secretion of insulin by binding to GLP-1 receptors and inhibits the secretion of glucagon, thereby promoting glucose metabolism
.
At the same time, it can also delay gastric emptying and suppress appetite, GLP-1 receptor is the most valuable target for the treatment of type 2 diabetes, obesity and non-alcoholic fatty liver and other metabolism-related diseases
.
Currently, 537 million adults worldwide are living with diabetes[1], and approximately 650 million people worldwide are obese[2].
According to statistics [3], the global GLP-1 receptor agonist drug market reached US$13.
1 billion in 2021 and is expected to grow to US$40.
7 billion
in 2030.
At present, GLP-1 receptor agonists such as semeglutide and liraglutide have been marketed, all of which are peptide macromolecule drugs
.
Preclinical studies of the small molecule GLP-1 receptor agonist MDR-001 have shown similar efficacy to peptides and higher safety windows, no immunogenicity, oral convenience, low cost, and convenient
storage and portability.
It is expected to bring better treatment results
to patients with diabetes and obesity.
MDR-001 is the first self-developed molecule of Derizhi Pharmaceutical
The innovative pipeline of the PRO one-stop AI-driven drug discovery platform assisted design is a non-competitive GLP-1 receptor agonist, and compared with similar clinical candidates, MDR-001 has similar or slightly better efficacy in vitro and in vivo, and greatly improves
druggability (including PK and safety window).
。 At the same time, long-term administration in the early pharmacodynamic model of diabetic combined with obese monkeys: in addition to effective glucose and weight reduction, MDR-001 can also restore HbA1c to the level of healthy monkeys, and there is no rebound in the recovery period after discontinuation, suggesting that MDR-001 helps repair damaged islet cells and restore islet function, showing the potential to cure early diabetes, and has obvious differentiation advantages and greater market potential
than existing therapeutic drugs and clinical investigational drugs.
References:
References:
[1] International Diabetes Federation.
IDF Diabetes Atlas, 10th edn.
Brussels, Belgium: 2021.
IDF Diabetes Atlas, 10th edn.
Brussels, Belgium: 2021.
[2] WHO.
Obesity and overweight.
June 9,2021.
Obesity and overweight.
June 9,2021.
[3] CICC.
Global and Chinese GLP-1 receptor agonist industry market size, competitive strategy research and future market development prospect evaluation and forecast
Global and Chinese GLP-1 receptor agonist industry market size, competitive strategy research and future market development prospect evaluation and forecast