Hybio Pharmaceutical Co., Ltd (SHE: 300199), a China-based pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the US Food and Drug Administration (FDA) for its liraglutide raw materials. The letter indicates no comments and no deficiencies, which is a significant step in the regulatory process.
Liraglutide, an analog of human glucagon-like peptide 1 (GLP-1), is a crucial drug target for the treatment of diabetes. It possesses a range of physiological functions that are beneficial for diabetes management. These include the glucose-dependent promotion of insulin secretion, protection of pancreatic islet beta cells, delay of gastric emptying, and reduction of appetite, among others.- Flcube.com