Hybio Pharmaceutical Co.,Ltd. (300199.SZ) has announced that the company recently received a clinical trial application acceptance notice from the US Food and Drug Administration (FDA) regarding HY3003 Injection.
HY3003 is a GLP-1R/GIPR/GCGR triple-target receptor agonist identified through AI peptide chip technology. It is intended for indications such as weight loss, type 2 diabetes, and metabolic dysfunction-associated steatohepatitis, and represents a significant innovative drug candidate in the company's metabolic disease pipeline.
The HY3003 project adopts a parallel multi-formulation development strategy, with development directions including HY3003 Injection (weekly formulation), HY3003 sustained-release injection (monthly formulation), and HY3003 tablets (once-daily oral formulation).