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 indications, today announced that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for the Phase I ATTRACT study of ATG-201, a CD19/CD3 bispecific T-cell engager antibody, for the treatment of B cell related autoimmune diseases. 

The ATTRACT study will be led by Prof. Zhanguo Li from Peking University People's Hospital as the principal investigator. 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.

Professor Zhanguo Li stated, "It is a great honor to lead the first-in-human (FIH) trial of Antengene's investigational drug ATG-201. Significant unmet clinical needs remain in patients with refractory B cell‑mediated autoimmune diseases, including low remission rates, high relapse risk, and long‑term safety concerns. ATG‑201, a dual CD3/CD19 T‑cell engager, redirects and activates autologous T cells to achieve precise elimination of pathogenic B cells—a novel mechanism that may overcome current therapeutic limitations. Our team, in close collaboration with the sponsor, Antengene, will rigorously conduct this Phase I study to evaluate the safety and preliminary efficacy."

Antengene and UCB have entered into an agreement that grants UCB a worldwide exclusive license to develop, manufacture, and commercialize ATG-201, along with access to its associated manufacturing technology. Antengene will conduct the FIH phase I clinical trials in China and Australia, and thereafter transfer all further clinical development activities to UCB.

The clinical trial application approval of ATG-201 by China's NMPA marks a critical step forward for Antengene as the company expands its strategic focus from oncology and hematology to include autoimmune diseases. This milestone demonstrates Antengene's determination and strong execution capabilities as it actively expands into autoimmune diseases, a therapeutic area with significant unmet need and growth potential. Looking ahead, Antengene will remain guided by unmet clinical needs, and continue to develop more first-in-class and/or best-in-class innovative therapies, bringing transformative treatment options to patients worldwide.