China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human fibroblast growth factor 21 injection B1344 in patients with type 2 diabetes. This marks a significant step in the development of this innovative biologic product.
Previous Clinical Progress
Previously, B1344, a Category 1 biologic product, entered a Phase Ia clinical study in nonalcoholic steatohepatitis (NASH) in the US after receiving IND approval in January of this year. The drug is being developed to treat both type 2 diabetes and NASH.
Drug Mechanism and Preclinical Results
B1344 is a PEGylated recombinant human fibroblast growth factor 21 mutant (PEG-rhmFGF21) designed to activate downstream signaling molecular pathways by combining with the co-receptor β-klotho protein and fibroblast growth factor receptor (FGFR). This mechanism significantly reduces fasting blood glucose, glucose tolerance, and glycosylated hemoglobin. Preclinical animal tests have shown that B1344 has various metabolic regulatory functions, including insulin-independent regulation of glucose and lipid metabolism, improvement of insulin resistance, protection of islet β-cell function, and long-lasting hypoglycemic effects without causing hypoglycemia. There is no similar product approved anywhere in the world.
Future Outlook
The approval from the NMPA to proceed with clinical trials for B1344 in type 2 diabetes underscores Tasly Pharmaceuticals’ commitment to advancing innovative treatments for metabolic diseases. With its unique mechanism and promising preclinical results, B1344 has the potential to address significant unmet needs in the treatment of type 2 diabetes.-Fineline Info & Tech
