CSPC Wins U.S. FDA Trial Nod for First-in-Class KAT6 Cancer Drug

CSPC Pharmaceutical Group ( (HK:1093) ) has shared an announcement.

CSPC Pharmaceutical Group and Hangzhou Innogate Pharma have secured U.S. FDA approval to begin clinical trials for SYH2095 tablets, a Class 1 chemical new drug targeting the lysine acetyltransferase 6 (KAT6) pathway. The orally administered candidate is designed as an epigenetic anticancer therapy for advanced malignant tumors, working by inhibiting histone lysine acetylation to regulate cell cycle, estrogen receptor expression, and cellular senescence.

Preclinical data showed SYH2095 achieved potent and selective KAT6 inhibition, robust tumor growth suppression, and favorable pharmacokinetics and safety, underscoring its potential as a differentiated oncology asset. With no approved drugs globally against the same KAT6 target, the program positions CSPC at the forefront of an emerging epigenetic niche in cancer treatment and could enhance the company’s innovation profile and competitive standing in the oncology pipeline if clinical results prove positive.

The most recent analyst rating on (HK:1093) stock is a Buy with a HK$13.05 price target. To see the full list of analyst forecasts on CSPC Pharmaceutical Group stock, see the HK:1093 Stock Forecast page.

More about CSPC Pharmaceutical Group

CSPC Pharmaceutical Group is a Hong Kong-incorporated pharmaceutical company focused on developing and commercializing innovative therapies, including oncology drugs. The group engages in research, production, and sales of a broad range of pharmaceutical products, with a growing emphasis on cutting-edge, first-in-class treatments for global markets.

Average Trading Volume: 105,469,604

Technical Sentiment Signal: Buy

Current Market Cap: HK$102.6B

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