Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for albenatide (CJC‑1134‑PC) for review. The company is seeking initial approval for the drug as an adjunct to diet and exercise to improve blood glucose control in patients with type 2 diabetes. The drug is intended for patients with poor blood glucose control after treatment with metformin alone or in combination with insulin secretagogues, or for previously untreated diabetic patients.
The Category 1 innovative drug candidate is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), which has been modified with Drug Affinity Complex (DAC) technology based on exenatide. The weekly injectable formulation is not currently under assessment for obesity or weight loss indications.- Flcube.com
