AN9025

July 16, 2026: Adlai Nortye Ltd. (NASDAQ: ANL) reported dosing the first U.S. patient in the intermittent once-weekly (QW) dose-escalation arm of its ongoing Phase 1 first-in-human trial of AN9025, an oral small-molecule pan-RAS(ON) inhibitor, in advanced/metastatic solid tumors harboring RAS mutations. The Phase 1 multicenter, open-label study is evaluating safety, tolerability, pharmacokinetics, and anti-tumor activity; both once-daily (QD) and QW dose-escalation arms are currently enrolling.

The company said intermittent weekly dosing is intended to potentially widen the therapeutic window based on preclinical data, supporting higher dosing and/or improved tolerability and combination potential while maintaining tumor RAS-signaling inhibition.

Adlai Nortye plans to share initial Phase 1 dose-escalation data from the QD arm in 1H 2027, with a potential early look at the QW arm.

The trial is being conducted as a multi-regional clinical trial with Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) under a license agreement in which Adlai Nortye retains ex-China rights to AN9025, while ASK Pharm holds rights in mainland China, Hong Kong, and Macao.