The board of directors of CSPC Pharmaceutical Group Limited announced that a highly selective MAT2A inhibitor (SYH2039) (the "Product"), a new Class 1 chemical drug developed by the Group, has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the U.S. Prior to this, the Product already obtained approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China in March 2024. SYH2039 is a highly active methionine adenosyltransferase 2A (MAT2A) inhibitor that can selectively kill MTAP-deficient tumor cells while having minimal impact on normal cells. The Product can be used alone or in combination with second-generation PRMT5 inhibitors to achieve synergistically enhancing efficacy.

The indication for this clinical trial approval is advanced malignant tumors. Preclinical studies have demonstrated that the Product can effectively inhibit the growth of various MTAP-deficient tumors such as non-small cell lung cancer, glioma, gastroesophageal cancer, pancreatic cancer and bladder cancer, with remarkable in-vivo and in-vitro activity. The Product also has good pharmacokinetics (PK) properties as well as a good safety profile, potentially to become a best-in-class anti-tumor drug.

Multiple patent applications have currently been filed in China and overseas. huge clinical needs exist as MTAP-deficient tumors lack effective targeted therapies, thus providing a promising clinical development value.