SHANGHAI and HONG KONG, China, June 10, 2026
Antengene 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 (TCE), for the treatment of B cell-related autoimmune diseases. The approval marks a significant milestone for Antengene as it expands beyond oncology and hematology into autoimmune diseases, an area with substantial unmet medical need. The company plans to rapidly initiate the first-in-human clinical study in China while preparing parallel clinical development activities in Australia.
Phase I ATTRACT Study to Evaluate Safety and Early Clinical Activity
The ATTRACT study will be led by Professor Zhanguo Li of Peking University People’s Hospital and is designed as a Phase I first-in-human trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell-related autoimmune diseases. The study will include both dose-escalation and dose-expansion phases, with the primary objective of determining the recommended Phase II dose (RP2D). Researchers aim to assess whether targeted B-cell depletion through ATG-201 can provide a new therapeutic option for patients with difficult-to-treat autoimmune disorders.
Novel CD19 × CD3 Bispecific T-Cell Engager Targets Pathogenic B Cells
ATG-201 is a next-generation CD19-targeting bispecific T-cell engager developed using Antengene’s proprietary steric hindrance masking technology. The therapy is designed to redirect and activate the body’s own T cells through CD3 while simultaneously targeting CD19-expressing B cells responsible for driving autoimmune disease activity. By enabling precise elimination of pathogenic B cells, ATG-201 has demonstrated potential to overcome limitations of existing therapies, including incomplete remission rates, high relapse risk, and long-term safety concerns associated with current treatment approaches.
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Partnership with UCB Supports Global Development Strategy
Antengene has entered into a worldwide exclusive licensing agreement with UCB covering the development, manufacturing, and commercialization of ATG-201. Under the agreement, Antengene will conduct the first-in-human Phase I studies in China and Australia before transferring further global clinical development responsibilities to UCB. The IND approval represents a major advancement in Antengene’s autoimmune disease strategy and strengthens the company’s broader pipeline of innovative T-cell engager therapies targeting autoimmune disorders, solid tumors, and hematological malignancies.
Source: Antengene, press release
