Adlai Nortye Submits Clinical Trial Notification To Australia's TGA And Receives Approval From HREC To Commence Phase I Clinical Trial Evaluating AN4035 For Treatment Of CEACAM5-Enriched RAS-Addicted Solid Tumors

First-in-class pan-RAS(ON) ADC is cleared for clinical development

Designed to selectively deliver pan-RAS(ON) inhibition to tumors while minimizing systemic toxicity.

IND submissions to U.S. FDA and China NMPA are in process

SINGAPORE and NORTH BRUNSWICK, N.J., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ:ANL) ("Adlai Nortye" or the "Company"), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it has submitted a Clinical Trial Notification (CTN) to Australia's Therapeutic Goods Administration (TGA) and received approval from the Human Research Ethics Committee (HREC) to commence its phase I clinical trial evaluating AN4035, a CEACAM5-targeting, pan-RAS(ON) inhibitor-based antibody drug conjugate (ADC) for the treatment of CEACAM5-enriched RAS-addicted solid tumors.