Henlius (02696.HK): HLX97 (KAT6A/B Inhibitor) Completes First Patient Dosing in Phase I Clinical Trial for Advanced Solid Tumors

NewTimeSpace News: Shanghai Henlius Biotech, Inc. (02696.HK) released a voluntary announcement on May 13, 2026, stating that the Phase I clinical trial of its in-house developed HLX97 (KAT6A/B small-molecule inhibitor) has achieved first patient dosing.

This is a multicenter, open-label Phase I study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of HLX97 in patients with advanced or metastatic solid tumors. The trial consists of a dose-escalation phase and a dose-expansion phase. Monotherapy dose escalation will be conducted in patients with advanced/metastatic solid tumors across five dose levels ranging from 1.0mg to 15.0mg. The combination regimen will explore HLX97 plus fulvestrant in HR-positive, HER2-negative locally advanced or metastatic breast cancer.

HLX97 is an in-house developed lysine acetyltransferase 6A/B small-molecule inhibitor. As histone lysine acetyltransferases, KAT6A and its paralog KAT6B play oncogenic roles in multiple tumor types. In breast cancer, amplification and overexpression of the KAT6A gene are proven closely linked to endocrine therapy resistance. Inhibition of KAT6 is expected to overcome such resistance. Non-clinical studies have shown that HLX97 can suppress KAT6A/B activity with favorable anti-tumor efficacy and safety profiles.
As of the announcement date, no KAT6A/B small-molecule inhibitor has been approved for commercial launch globally.

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