Hybio Pharmaceutical (300199.SZ): HY3003 Injection Receives U.S. FDA Clinical Trial Authorization

Hybio Pharmaceutical (300199.SZ) announced that the company recently received a clinical trial authorization notice from the U.S. Food and Drug Administration (FDA) for HY3003 Injection (IND number: 184763). The FDA has completed its safety review of the IND application and agreed that the company may conduct the first clinical trial in accordance with the submitted clinical trial protocol. HY3003 is a novel GLP-1R/GIPR/GCGR triple receptor agonist in the company's pipeline. The project adopts a parallel multi-dosage-form development strategy, with development directions including HY3003 Injection (weekly formulation), HY3003 sustained-release injection (monthly formulation), and HY3003 tablets (once-daily oral formulation). The HY3003 Injection that received FDA clinical trial authorization this time is administered via subcutaneous injection once weekly. HY3003 is intended for indications such as weight loss, type 2 diabetes, and metabolic dysfunction-associated steatohepatitis, and is a major innovative drug candidate in the company's metabolic disease portfolio. Preclinical pharmacodynamic study results showed that at the same molar dose, HY3003 Injection demonstrated superior weight-loss efficacy in the DIO mouse model compared with the marketed dual-target agonist tirzepatide and the investigational triple-target agonist retatrutide, while also showing favorable pharmacodynamic characteristics in lowering blood glucose, reducing fat, and improving hepatic steatosis.