Henlius’s potential best-in-class small molecule drug receives its first clinical trial approval

March 5, 2026  Source: drugdu 31

"/On March 4, the CDE (Center for Drug Evaluation) website showed that Henlius' HLX97 clinical trial application was approved for the treatment of advanced/metastatic solid tumors. This is the third domestically produced KAT6A/B inhibitor to receive clinical trial approval.

"/Source: CDE Official Website


HLX97 is a novel, potentially best-in-class oral histone acetyltransferase (KAT6A/B) inhibitor . KAT6A/B is a highly promising target for the treatment of solid tumors such as breast cancer, and its abnormalities are closely associated with the development and progression of various hematologic malignancies and solid tumors.
HLX97 regulates the proliferation, differentiation, and apoptosis of tumor cells by precisely inhibiting the activity of KAT6A/B. It has pharmacokinetic characteristics of rapid onset and rapid clearance and high selectivity. It aims to maximize the anti-tumor activity of the drug while reducing the blood toxicity of the product, and is expected to bring new treatment options to patients with cancers such as breast cancer.
According to the Insight database , there are currently three KAT6A/B inhibitors in China that have entered the clinical stage, including Prifetrastat (Pfizer) , QLS1304 (Qilu) , and BG-75202 (BeiGene) .
https://mp.weixin.qq.com/s/rHbTufvVwp0mIn11p4PhdQ

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