Gelonghui, April 26, 丨 Shiyao Group (01093.HK) announced that the Class 1 new chemical highly selective MAT2A inhibitor (SYH2039) developed by the Group has been approved by the US Food and Drug Administration (FDA) and can conduct clinical trials in the US. Previously, the product was approved by China's National Drug Administration in March 2024, and clinical trials can be carried out in China.

SYH2039 is a highly active methionine adenoganase 2A (MAT2A) inhibitor that selectively kills MTAP-deficient tumor cells and has little effect on normal cells. This product can be used alone or used in combination with PRMT5 second-generation inhibitors, etc. The clinical indication approved this time is advanced malignant tumors. Preclinical studies have shown that this product can effectively inhibit the growth of various MTAP-deficient tumor cells such as non-small cell lung cancer, glioma, gastroesophageal cancer, pancreatic cancer, and bladder cancer. It has excellent activity in vitro and in vitro, and also has good PK characteristics and safety. It has the potential to become a best-in-class (best-in-class) anti-tumor drug in its class. It has now submitted many patent applications at home and abroad. Tumors lacking MTAP lack effective targeted therapy and are in high clinical demand. This product has great clinical development value.