Antengene Corporation Limited said its Phase I ATTRACT study of ATG-201, a CD19/CD3 bispecific T-cell engager antibody for B cell-related autoimmune diseases, received approval from Australia’s Human Research Ethics Committee and completed the Clinical Trial Notification process with the Therapeutic Goods Administration (TGA), Australia’s medicines regulator. The study will assess the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adults through dose escalation and dose expansion, with the recommended Phase II dose as a primary objective. Secondary measures include pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy. ATG-201 uses steric-hindrance masking technology to target and eliminate CD19-expressing B cells by engaging T cells through CD3. The Australian clearance follows China’s NMPA approval of the clinical trial application in June 2026. Antengene will conduct Phase I trials in China and Australia under an agreement granting UCB worldwide exclusive rights to further develop, manufacture and commercialize ATG-201 and access its related manufacturing technology. The milestones support Antengene’s multi-regional development strategy and its expansion beyond oncology and hematology into autoimmune diseases, although the company cautioned that future results may differ materially from its forward-looking statements.