CSPC：SYH2095 has received its first clinical trial approval.
In May 2026, SYH2095 Tablets, co-developed by CSPC Pharmaceutical Group and Yingchuang Pharmaceutical, received approval from the CDE to conduct clinical trials for advanced malignant tumors. In April of this year, the drug had already received approval from the U.S. FDA to conduct clinical studies in the United States.
In 2019, CSPC Pharmaceutical Group entered into a collaboration with Yingchuang Pharmaceutical, obtaining exclusive development and commercialization rights in China and the United States for five innovative anti-tumor small-molecule drug candidates, including SYH2095. This collaboration includes a RMB 25 million upfront payment and up to RMB 200 million in development milestone payments.
SYH2095 is a novel lysine acetyltransferase 6 (KAT6) inhibitor, belonging to the class of epigenetic anti-cancer drugs. This candidate drug exerts its anti-tumor effects by inhibiting histone lysine acetylation and blocking open chromatin, thereby regulating cell cycle, estrogen receptor expression, and cellular senescence pathways.
According to the Insight database, the world’s most advanced KAT6-targeting drug is Pfizer’s Prifetrastat, which is in Phase III clinical trials. The second most advanced is Hengrui’s HRS-2189, currently in Phase II clinical trials; CSPC Pharmaceutical Group’s SYH2095 is relatively advanced in the domestic development landscape.
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