Shijiazhuang Pharma Group (01093): Phase I Clinical Trial of SYH2095 Tablets for Monotherapy or Combination Therapy in Advanced Malignancies Officially Launched in China

Zhitong Finance APP News: CSPC (01093) announced that the Phase I clinical study of SYH2095 tablets (the product), jointly developed by the Group and Hangzhou Yingchuang Pharmaceutical Technology Co., Ltd., for the treatment of advanced malignant tumors as monotherapy or in combination regimens, has officially launched in China.

This product is a Class 1 innovative chemical drug and a highly selective inhibitor of lysine acetyltransferase 6 (KAT6), representing a novel mechanism-based epigenetic anti-tumor agent. By inhibiting the acetylation of histone lysine, it restricts chromatin accessibility, thereby regulating the cell cycle, estrogen receptor expression, and cellular senescence pathways to exert its anti-tumor effects. Preclinical data demonstrate that this product exhibits potent target inhibition activity and robust in vivo anti-tumor efficacy, along with favorable pharmacokinetic properties and safety profiles.

Currently, no drugs targeting the same indication have been approved for marketing either domestically or internationally. There is a significant unmet clinical need in the treatment of advanced malignant tumors. In May 2026, this product received the Notice of Approval for Clinical Trials issued by the National Medical Products Administration (NMPA). The Group subsequently expedited all preparatory work and officially launched this Phase I clinical study.

This is an open-label, multicenter Phase I clinical study. The primary objectives are to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of this product as monotherapy and in combination regimens for the treatment of advanced malignant tumors. Through scientifically rigorous trial design, this study will provide key evidence for the subsequent clinical development of this product. Currently, the initiation of relevant study centers is being actively advanced.