Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, today announced that the Phase I ATTRACT study of our proprietary ATG-201, a CD19/CD3 bispecific T-cell engager antibody for B cell-related autoimmune diseases, has received approval from the Human Research Ethics Committee (HREC) in Australia, and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA).

ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. This bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body's own immune system for precise and potent action.

This is a Phase I clinical study designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases. The study will consist of two phases: dose escalation and dose expansion. The primary objectives of the study are to evaluate the safety and tolerability of ATG-201 monotherapy and to determine its recommended Phase II dose (RP2D). Secondary objectives include evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) profiles, immunogenicity, preliminary efficacy of ATG-201.

Antengene and UCB have entered into an agreement that grants UCB worldwide exclusive rights to further develop, manufacture, and commercialize ATG-201, and access to its associated manufacturing technology in relation to ATG-201. Antengene will conduct the phase I clinical trials in China and Australia.

The clinical trial approval in Australia, following the clearance of ATG-201's clinical trial application by China's NMPA in June this year, marks an important advancement in Antengene's multi-regional development strategy for ATG-201. Together, these milestones demonstrate Antengene's ability to execute efficiently across key clinical markets and reflect the company's forward-looking approach to building ATG-201 into a potential global program for B cell-related autoimmune diseases. As Antengene continues to expand its innovation focus beyond oncology and hematology into autoimmune diseases, the company remains committed to addressing areas of significant unmet medical need and to developing differentiated, potentially first-in-class and/or best-in-class therapies for patients worldwide.