ATG-022

Shanghai – September 20, 2026 -- Antengene Corporation Limited (SEHK: 6996.HK) has dosed the first patient in China in its pivotal Phase III CLINCH-3 study evaluating ATG-022, a CLDN18.2 antibody-drug conjugate, as monotherapy for CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Breakthrough Therapy Designation accelerated the trial's launch

China's National Medical Products Administration granted ATG-022 Breakthrough Therapy Designation, which the company says streamlined regulatory communications and enabled the rapid start of CLINCH-3. The randomized, controlled, open-label multicenter study is initiated in China and planned for expansion into a multi-regional clinical trial, with Professor Lin Shen of Peking University Cancer Hospital serving as principal investigator. The study compares ATG-022 against treatment of investigator's choice, targeting a future marketing approval application.