NewTimeSpace: Shanghai Henlius Biotech, Inc. (02696.HK) issued a voluntary announcement on March 5, stating that the Phase 1 clinical trial application of HLX97 (KAT6A/B small-molecule inhibitor), a self-developed product of the company, in patients with advanced/metastatic solid tumors has been approved by the NMPA.

HLX97 is a self-developed small-molecule inhibitor of lysine acetyltransferase 6A/B (KAT6A/B) by the company, intended for the treatment of advanced/metastatic solid tumors. As histone lysine acetyltransferases, KAT6A and its paralog KAT6B can participate in the acetylation of lysine residues on histone H3 together with other chromatin-associated proteins, thereby exerting an oncogenic effect in various tumor types. In breast cancer, the amplification/overexpression of the KAT6A gene has been proven to be closely related to the development of endocrine therapy resistance. Therefore, inhibiting KAT6 is expected to overcome endocrine therapy resistance. Non-clinical studies have shown that HLX97 can inhibit the activity of KAT6A/B, with good anti-tumor efficacy and safety profiles.

As of the date of this announcement, no KAT6A/B small-molecule inhibitors have been approved for marketing worldwide.

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