Antengene Corporation Limited

SHANGHAI and HONG KONG, Aug. 25, 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, 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.

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; partnered with K2 Therapeutics established by MPM BioImpact), 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 34 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:

PR / IR Contacts: 

Peter Qian

E-mail: peter.qian@antengene.com

BD Contacts:

Ariel Guo

E-mail: ariel.guo@antengene.com

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SOURCE Antengene Corporation Limited

SHANGHAI and HONG KONG, Aug. 24, 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, today provided an overview of its interim results for the period ended June 30, 2026, which were announced on August 21, 2026, together with recent business highlights and strategic progress.

Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, said, "In H1 2026, Antengene achieved its first‑ever profitability, with total revenue of RMB 513 million, representing a year‑on‑year increase of 864.5%, and profit for the period of RMB 216 million. This is an important validation of our strategy to create value through internal innovation and global partnerships. The successful execution of our partnering strategy is translating the strength of our pipeline into meaningful financial returns. Most notably, our global exclusive license agreement with UCB for ATG‑201 (CD19 x CD3 T‑cell engager [TCE]) generated a USD 60 million upfront payment. We also entered into an exclusive license agreement with K2 Therapeutics, established by MPM BioImpact, for ATG‑106 (first‑in‑class CDH6 x CD3 TCE), under which the aggregate upfront and near‑term consideration amounts to approximately USD 20 million. Together with potential milestone payments and tiered royalties from these partnerships, as well as commercial revenue from XPOVIO^®, these revenue streams further strengthen our financial position and expand our capacity to invest in innovation.

Our late-stage clinical program ATG‑022 (CLDN18.2 antibody‑drug conjugate [ADC]) has received CDE Breakthrough Therapy Designation, demonstrating strong efficacy and best-in-class safety in gastric cancer across all levels of CLDN18.2 expression, as well as in other CLDN18.2+ solid tumors. We are advancing two key clinical studies in gastric cancer: the CLINCH‑2 study, evaluating ATG‑022 in combination with chemotherapy and an anti‑PD‑1 antibody in the 1L treatment of patients with gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) with CLDN18.2 IHC 1+ ≥ 1%; and the pivotal Phase III CLINCH‑3 study evaluating ATG-022 monotherapy for GC/GEJC patients with CLDN18.2 IHC 2+ ≥ 20%. We are confident in the potential of ATG-022 to benefit a broad population of patients with CLDN18.2-expressing tumors and believe it is well positioned to become a cornerstone of our pipeline and one of our most important future value drivers.

In TCE innovation, we continue to expand our capabilities beyond our established AnTenGager^® TCE platform. We have successfully developed and newly launched TriGager^™, our next generation logic-gated tri-specific TCE platform, together with new TCE formats incorporating costimulatory moieties, further broadening our comprehensive TCE engineering toolbox. We are also deepening the integration of AI across our R&D engine. By linking multi-omics analysis with internally generated protein datasets, our AI platform identifies novel targets and target combinations, informs molecular design, and optimizes antibody developability. The platform has already contributed to the nomination of ATG-115, a T-cell engager (TCE) for hepatocellular carcinoma (HCC) directed at a novel, AI-identified tumor-associated antigen. AI-enabled combinatorial screening has also surfaced multiple novel target pairs now advancing toward future TriGager^™ programs. Combined with the differentiated engineering of our AnTenGager^® and TriGager^™ platforms, AI expands the range of molecules we can design for diseases of high unmet medical need.

Beyond these programs, we are advancing the next wave of internally generated innovation. ATG-125, our B7-H3 x PD-L1 bispecific ADC, has demonstrated encouraging preclinical efficacy, with an IND submission planned for Q1 2027. ATG-207, our first-in-class αCD3-TGF-β bifunctional fusion protein, represents a differentiated approach to restoring immune tolerance in T cell-mediated autoimmune disease. ATG‑112, our first‑in‑class ALPPL2 × CD3 TCE, targets gynecological tumors, digestive system malignancies, bladder cancer and NSCLC. ATG‑110, our LY6G6D × CD3 TCE, targets IO‑resistant microsatellite‑stable colorectal cancer. Together, these programs highlight the breadth of our innovation and represent potential future value drivers across oncology and autoimmune diseases.

As Antengene enters its next stage of development, we will continue to strengthen our R&D capabilities, advance our clinical pipeline and deepen global partnerships. With sustained innovation and a stronger financial position, we are well positioned to execute our strategy and create long‑term value."

【Business Updates】

1.ATG-022（CLDN18.2 ADC）

• Latest data from the Phase II CLINCH study: As of June 26, 2026, among patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 42.4% (14/33) and a disease control rate (DCR) of 90.9% (30/33), with a median overall survival (mOS) of 12.85 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), and the mOS had not yet been reached after a median follow‑up of 14.03 months. Among patients with low/ultra-low CLDN18.2 expression treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21) and the DCR was 52.4% (11/21). In addition, one patient in each of the three cohorts achieved a complete response (CR). These results demonstrated the robust anti-tumor activity of ATG-022 across all levels of CLDN18.2 expression.
• Favorable safety profile: Compared with the data cutoff of December 25, 2025, the incidence of Grade ≥3 treatment‑related adverse events (TRAEs) in the 1.8 mg/kg dose cohort increased slightly from 19.4% to 21.0%, with only 9.7% of patients experiencing dose reduction due to TRAEs. Despite more than six additional months of treatment exposure and follow‑up, the incidence of Grade ≥3 TRAEs remained broadly stable in the 1.8 mg/kg dose cohort. This favorable safety profile supports the continued development of ATG‑022 in combination with chemotherapy and an anti-PD-1 antibody in the 1L setting, further expanding its therapeutic potential.
• mOS not yet reached in the 1.8 mg/kg dose cohort: After a median follow‑up of 14.03 months, mOS had not yet been reached in the 1.8 mg/kg dose cohort, further supporting the potential for durable clinical benefit with ATG-022.
• Three Complementary Development Paths Position ATG-022 for Near-Term Registration, 1L Leadership, and Broader Patient Reach: CLINCH-3 provides a near-term registration pathway for ATG-022 monotherapy at the optimized 1.8 mg/kg dose in 3L+ gastric/GEJ cancer with CLDN18.2 IHC 2+ ≥ 20%, establishing ATG-022 in gastric cancer. CLINCH-2 is evaluating ATG-022 in 1L in combination with standard-of-care chemotherapy and anti-PD-1 therapy, targeting the broadest CLDN18.2-positive population starting from IHC 1+ ≥ 1%, with the goal of supporting 1L registration and unlocking the full potential of ATG-022 in gastric cancer. Meanwhile, the CLINCH basket trial is expanding ATG-022 beyond gastric cancer, with encouraging efficacy already observed in a gynecological tumor subtype and other CLDN18.2-positive solid tumors.

2. AnTenGager^® & TriGager^™ TCE Platforms

There is no one-size-fits-all approach to designing TCE molecules across different targets and indications. Achieving optimal balance between efficacy and safety requires tailoring each molecule to the underlying target biology. To this end, Antengene has built a comprehensive TCE engineering toolbox comprising its proprietary AnTenGager^® and TriGager^™ platforms, together with multiple functional modules. This modular system enables Antengene's R&D team to customize molecular formats and designs for different targets, improving development efficiency while supporting differentiated clinical strategies.

• AnTenGager^® TCE platform: AnTenGager^® is Antengene's proprietary, second-generation TCE platform featuring "2+1" bivalent binding format 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 differentiated features support the platform's broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has built a pipeline of multiple drug candidates, two of which have entered into exclusive out-licensing agreements:
  • ATG-201 (CD19 x CD3 TCE): Antengene entered into a global exclusive license agreement with UCB. The Company has received USD 60 million upfront payment from UCB to date and is eligible to receive an additional USD 20 million near‑term milestone payment, up to approximately USD 1.1 billion in additional milestone payments, as well as tiered royalties on future net sales. ATG‑201 has obtained approvals from China's National Medical Products Administration (NMPA) to initiate the Phase I ATTRACT study for the treatment of B cell related autoimmune diseases.
  • ATG-106 (first-in-class CDH6 x CD3 TCE): Antengene entered into an exclusive license agreement with K2 Therapeutics, a company established by MPM BioImpact. The aggregate upfront and near‑term considerations amounts to approximately USD 20 million. We are also eligible to receive up to USD 960.5 million in additional milestone payments, as well as tiered royalties on future net sales. The Company plans to submit an IND application for ATG-106 in H1 2027.
• TriGager^™ TCE platform: TriGager^™ is Antengene's proprietary tri‑specific TCE platform incorporating steric hindrance masking technology and supporting multiple logic-gated formats, including AND‑Gate, True AND‑Gate and OR‑Gate. AND‑Gate and True AND‑Gate molecules require target cells to co‑express two disease‑associated antigens before T‑cell‑mediated cytotoxicity can be triggered. This mechanism improves target specificity, reduces on-target-off-tumor toxicity, and expands the pool of druggable targets for TCE modalities. In contrast, OR‑Gate molecules trigger T‑cell‑mediated killing upon recognition of either one of the disease‑associated antigens, helping address heterogeneity in target expression. The platform also supports the incorporation of an engineered CD2 co‑stimulatory moiety, which optimizes molecular developability, enhances TCE potency, and mitigates the risk of CRS, further optimizing the balance between efficacy and safety.

3. Next Generation ADCs and Other Novel Programs

• ATG-125 (B7-H3 x PD-L1 bispecific ADC): ATG-125 is an "IO + ADC" dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of IO therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target ADC approaches. The Company plans to submit an IND application for ATG-125 in Q1 2027.
• ATG-207 (αCD3-TGF-β Bifunctional Fusion Protein): ATG-207 is a globally first-in-class αCD3-TGF-β bifunctional fusion protein being developed for the treatment of T cell–mediated autoimmune diseases. The Company first disclosed its preclinical data at the 2026 European Congress of Rheumatology (EULAR 2026).

【Highlights of Financial Results】

• As of the end of the reporting period, the Company recorded total revenue of RMB 513 million for H1 2026, representing a year‑on‑year increase of 864.5%. Profit for the period stood at RMB 216 million, marking the Company's first profitable period.
• As of June 30, 2026, the Company held cash and bank balances of RMB 765 million. In addition, under the license agreement with UCB, the Company received license revenue of approximately RMB 195 million from UCB in July 2026. The Company is also eligible to receive a near‑term milestone payment of approximately RMB 136 million.

To learn more about the 2026 interim results, please see the full announcement in the "Investor Relations" section on the company's website.

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 x 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; partnered with K2 Therapeutics established by MPM BioImpact), 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:

PR / IR Contacts: 

Peter Qian

E-mail: peter.qian@antengene.com  

BD Contacts:

Ariel Guo

E-mail: ariel.guo@antengene.com 

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SOURCE Antengene Corporation Limited