Press Release: Antengene Announces 2026 Interim Results: Achieves First

Dow Jones
11小時前

SHANGHAI and HONG KONG, Aug. 23, 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$(R)$ , 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(R) TCE platform. We have successfully developed and newly launched TriGager$(TM)$ , 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(TM) programs. Combined with the differentiated engineering of our AnTenGager(R) and TriGager(TM) 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 <ALPHA>CD3-TGF-<BETA> 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(R) & TriGager(TM) 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(R) and TriGager(TM) 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(R) TCE platform: AnTenGager(R) 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 

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