Shanghai and Hong Kong, China, August 25, 2026
Antengene Corporation Limited announced that the Phase I ATTRACT clinical study of ATG-201 has received approval from Australia’s Human Research Ethics Committee (HREC) and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA). The regulatory milestone clears the path for clinical evaluation of ATG-201, an investigational CD19 × CD3 bispecific T-cell engager (TCE) being developed for B cell-related autoimmune diseases. The Australian approval expands the program’s multinational development strategy after China’s National Medical Products Administration (NMPA) cleared the clinical trial application in June 2026. Antengene plans to conduct Phase I development in both China and Australia, supporting the company’s objective of evaluating ATG-201 across multiple clinical markets. The program is being developed in partnership with UCB, which holds worldwide exclusive rights to further develop, manufacture and commercialize ATG-201 and access its associated manufacturing technology.
ATG-201 Designed to Eliminate CD19-Positive B Cells
ATG-201 is designed to target CD19-expressing B cells through a CD19/CD3 bispecific mechanism, bringing T cells into contact with B cells to activate the body’s immune system against the targeted cells. The molecule incorporates Antengene’s steric hindrance masking technology, which is intended to support controlled target engagement. B cells play important roles in antibody production and immune regulation, and abnormal B-cell activity is implicated in multiple autoimmune disorders. By directing T-cell activity toward CD19-positive B cells, ATG-201 is being investigated as a potential approach for B cell-driven autoimmune diseases. However, the therapy remains investigational, and the Phase I ATTRACT study will be important for determining whether the proposed mechanism can translate into an acceptable safety profile and meaningful clinical activity in patients.
ATTRACT Phase I Study to Evaluate Safety and Dose
The Phase I ATTRACT study is designed primarily to assess the safety and tolerability of ATG-201 monotherapy in adults with B cell-related autoimmune diseases, while also generating preliminary efficacy data. The study will include dose escalation and dose expansion phases, with the primary objectives including characterization of safety and tolerability and determination of the recommended Phase II dose (RP2D). Investigators will also evaluate pharmacokinetic and pharmacodynamic characteristics, immunogenicity and preliminary measures of clinical efficacy. The study represents an early clinical-stage evaluation, meaning that the available information does not yet establish ATG-201’s effectiveness or long-term safety. Data generated through the trial will help determine appropriate dosing and whether the program can progress into later-stage clinical development.
Advertisement
Australia Milestone Strengthens Global Development Strategy
The Australian regulatory clearance adds another important step to Antengene’s strategy to develop ATG-201 as a potential global therapy for B cell-related autoimmune diseases. The milestone follows China’s NMPA clinical trial clearance and allows the company to advance the Phase I program across two major clinical development markets. Antengene and UCB entered an agreement granting UCB worldwide exclusive development, manufacturing and commercialization rights for ATG-201, while Antengene will conduct the Phase I trials in China and Australia. The program is also part of Antengene’s broader AnTenGager® TCE platform, which incorporates technologies designed to support targeted T-cell engagement across autoimmune diseases, solid tumors and hematological malignancies. For ATG-201 specifically, the immediate focus remains establishing clinical safety, tolerability and an appropriate dose before determining its potential role in later-stage development.
Source:Antengene press relese
