Adlai Nortye Ltd. announced on August 3, 2026, that it has submitted a Clinical Trial Notification to Australia’s Therapeutic Goods Administration and received Human Research Ethics Committee approval to commence its Phase I clinical trial for AN4035. This first-in-class antibody drug conjugate targets CEACAM5-enriched RAS-addicted solid tumors using the company's proprietary RASiCA platform. Patient dosing is expected to begin in the second half of 2026, with investigational new drug applications also pending with the U.S. FDA and China NMPA. Adlai Nortye Ltd. operates as a clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies.
