Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes.
Trulicity, originally developed by US pharmaceutical giant Eli Lilly, is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. It activates GLP-1 receptors, increases the content of cyclic adenosine monophosphate (cAMP) in β cells, stimulates glucose-dependent insulin release, inhibits glucagon secretion, and delays gastric emptying. The drug received approval in the US and Europe in September and November of 2014, respectively, and was granted market access in China in February 2019 for use in controlling blood sugar levels in type 2 diabetes as a monotherapy or in combination with metformin and/or sulfonylurea. BA5101 is the first biosimilar of this molecule to enter the regulatory review phase in China.- Flcube.com
