CSPC Pharma Receives U.S. FDA Clearance to Begin Clinical Trials for First-in-Class KAT6 Inhibitor SYH2095

Bulletin Express04-24

On 24 April 2026, CSPC Pharmaceutical Group Limited (CSPC Pharma) announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for SYH2095 tablets, enabling the commencement of clinical trials in the United States. The candidate, co-developed with Hangzhou Innogate Pharma Co., Ltd., is classified as a Class 1 chemical new drug in China.

SYH2095 is a highly selective inhibitor of lysine acetyltransferase 6 (KAT6), targeting epigenetic mechanisms to suppress tumor growth. Pre-clinical data demonstrated potent, selective KAT6 inhibition, significant tumor-growth suppression, favorable pharmacokinetics, and a promising safety profile.

No KAT6-targeting therapy has yet received marketing approval worldwide, underscoring SYH2095’s potential first-in-class status and clinical development value for patients with advanced malignant tumors.

The Board of CSPC Pharma, chaired by Mr. Cai Dong Chen, formally disclosed the development on the Hong Kong Stock Exchange as a voluntary announcement.

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