CSPC PHARMA (01093) announced that the innovative Class 1 chemical drug SYH2095 tablets, co-developed with Hangzhou Yingchuang Pharmaceutical Technology Co., Ltd., has received approval from the National Medical Products Administration (NMPA) of China to commence clinical trials within the country. Previously, this product also obtained approval from the U.S. Food and Drug Administration (FDA) to proceed with clinical trials in the United States in April 2026. SYH2095 is a novel lysine acetyltransferase 6 (KAT6) inhibitor, belonging to a class of epigenetic anti-cancer drugs. It exerts its anti-tumor effects by inhibiting histone lysine acetylation, blocking open chromatin, and subsequently regulating cell cycle, estrogen receptor expression, and cellular senescence pathways. It is intended for the treatment of advanced malignant tumors. Preclinical studies indicate that the product demonstrates highly potent and selective inhibition of KAT6, significantly suppressing tumor growth, and exhibits favorable pharmacokinetic properties and safety. Currently, no drugs targeting this same mechanism are approved for marketing globally, highlighting the substantial clinical development value of this product.
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