Zhitong Finance App News, Hanyu Pharmaceutical (300199.SZ) issued an announcement. The company recently received the clinical trial license notice for HY3003 injection (IND number: 184763) issued by the US Food and Drug Administration (FDA). The FDA has completed the safety review of this IND application and agreed that the company will conduct the first clinical trial in accordance with the submitted clinical trial protocol.

HY3003 is a novel GLP-1R/GIPR/GCGR triple receptor agonist deployed by the company. The project uses a multi-dosage parallel development strategy. Development directions include HY3003 injections (weekly formulations), HY3003 extended-release injections (monthly formulations), and HY3003 tablets (once-daily oral formulation). HY3003 injections approved for clinical trials by the FDA are injected subcutaneously once a week. HY3003 is intended for indications such as weight loss, type 2 diabetes, and metabolism-related steatohepatitis. It is a major innovative drug type deployed by the company in the field of metabolic diseases.

Preclinical pharmacodynamic study results showed that at the same molar dose, HY3003 injection had better weight loss effects in DIO mouse models than the marketed dual-target agonist tirpotide and the three-target agonist ritacreotide under development. At the same time, it also showed good pharmacodynamic characteristics in lowering sugar, reducing fat, and improving liver steatosis.

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