Antengene Receives IND Approval for ATG-201 (CD19 × CD3 TCE) in Autoimmune Disease in China

Antengene Receives IND Approval for ATG-201 (CD19 × CD3 TCE) in Autoimmune Disease in China

SHANGHAI and HONG KONG, June 10, 2026 /PRNewswire/ -- 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. 

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. Antengene plans to promptly initiate and advance the Phase I ATTRACT study in China, while concurrently preparing for the clinical development of ATG-201 in Australia.

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.

About Antengene 
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages, with key investigational candidates including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 x 4-1BB bispecific antibody), ATG-125 (B7-H3 × PD-L1 bispecific ADC), ATG-207 (αCD3-TGF-β bifunctional fusion protein), as well as T cell engager (TCE) programs developed using Antengene's proprietary AnTenGager^® platform.

AnTenGager^®, is Antengene's proprietary TCE 2.0 platform, featuring "2+1" bivalent binding for low expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies, with programs targeting CD19 x CD3 (ATG-201 for B cell-related autoimmune diseases; partnered with UCB), CDH6 x CD3 (ATG-106 for ovarian cancer and kidney cancer), ALPPL2 x CD3 (ATG-112 for gynecological tumors, digestive system malignancies, bladder cancer and NSCLC), LY6G6D x CD3 (ATG-110 for microsatellite-stable colorectal cancer), GPRC5D x CD3 (ATG-021 for multiple myeloma), LILRB4 x CD3 (ATG-102 for acute myeloid leukemia and chronic myelomonocytic leukemia) and FLT3 x CD3 (ATG-107 for acute myeloid leukemia).

To date, Antengene has obtained 33 investigational new drug (IND) approvals in the U.S. and Asia, and obtained new drug application (NDA) approvals in 10 Asia Pacific markets. Its lead commercial asset, XPOVIO^® (selinexor), is approved in the Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore).

Forward-looking statements
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2025, and the documents subsequently submitted to the Hong Kong Stock Exchange.

For more information, please contact:

Investor Contacts: 
Donald Lung
E-mail: donald.lung@antengene.com 

BD Contacts:
Ariel Guo
E-mail: ariel.guo@antengene.com

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SOURCE Antengene Corporation Limited