CSPC Group (01093): SYH2046 tablets approved for clinical trials in the US

According to Zhitong Finance App, Shiyao Group (01093) issued an announcement. SYH2046 tablets (this product), a Class 1 new chemical developed by the Group, have been approved by the US Food and Drug Administration (FDA) and can conduct clinical trials in the US. The product was also approved by the State Drug Administration of the People's Republic of China in April 2025, and clinical trials can be carried out in China.

This product is a first-in-class small-molecule drug with a new structure with completely independent intellectual property rights. The approved clinical trial indication is heart failure after acute myocardial infarction. Preclinical studies have shown that the product can significantly improve cardiac function and reduce poor cardiac remodeling in animal models of diseases, and is highly safe.

Compared with traditional heart failure drugs, this product has a novel mechanism of action. It is expected to actively promote tissue repair in the early stages of myocardial damage by improving cardiac cell metabolism to enhance cardiac function after myocardial infarction, and has great clinical development value. Currently, the Group has submitted a number of patent applications for this product at home and abroad.