On June 24, Gelunhui reported that Hybio Pharmaceutical (300199.SZ) recently received a notice from the US Food and Drug Administration (FDA). The abbreviated new drug application (ANDA) for Liraglutide Injection jointly submitted by Hybio Pharmaceutical and Hikma Pharmaceuticals USA, Inc. has been tentatively approved by the FDA. Tentative Approval: means that the FDA has completed all evaluation requirements for generic drugs, that is, after the drug has been reviewed, its quality, safety, and effectiveness are in compliance with the standards for listing in the United States. Due to patent and/or exclusivity rights that have not yet expired, it is a form of approval given. Only after the patent or exclusivity issue is resolved can the US FDA grant eligibility for sale in the US terminal market.
Liraglutide-1 is a GLP-1 analogue of human glucagon-like peptide-1 (GLP-1), which is an important drug target. It has multiple physiological functions: glucose-dependent promotion of insulin secretion, protection of pancreatic beta cells, delayed gastric emptying and reduced appetite.