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The Phase I/II CLINCH study of ATG-022 (CLDN18.2 antibody-drug conjugate) demonstrated promising results, showing robust clinical efficacy and a favorable safety profile in patients with gastric/gastroesophageal junction adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels. Supported by these results, ATG-022 was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The Phase I/II STAMINA study of ATG-037 (Oral CD73 small molecule inhibitor) is progressing smoothly. The latest data show particularly encouraging efficacy in the CPI-resistant melanoma subgroup, with an objective response rate (ORR) of 36.4%, a disease control rate (DCR) of 100%, including 1 CR and 3 partial responses (PRs). In the CPI-resistant non-small cell lung cancer (NSCLC) subgroup, the ORR was 21.4%, the DCR was 71.4%, including 3 PRs. Expanding its pipeline's therapeutic area to autoimmune diseases, Antengene released the preclinical data of ATG-201, a CD19 x CD3 TCE with steric hindrance masking technology. In non-human primate (NHP) models, repeated dosing of ATG-201 surrogate at 1mpk, 3mpk, and 6mpk was well tolerated and associated with very low cytokine release. ATG-201 is expected to enter clinical development in Q4 2025. In the first half of 2025, XPOVIO® generated a revenue of RMB 53.2 million, which rose sharply by 70.6% period-over-period. In addition to the rapid revenue growth, the company's operational efficiency continued to improve, with sales and administrative expenses declining by 34.0% and 32.8% year-over-year, respectively. SHANGHAI and HONG KONG, Aug. 22, 2025 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) today announced its interim results for the period ending June 30, 2025, along with an update highlighting some of its recent achievements. Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, said, "In the first half of 2025, Antengene delivered a series of milestone achievements. Our core mid/late-stage clinical asset, ATG-022, was granted a Breakthrough Therapy designation by the NMPA based on its outstanding clinical data that demonstrated efficacy across all CLDN18.2 expression levels. This underscores ATG-022's distinctive characteristics as a potential backbone therapy for the treatment of gastric cancer. Moreover, ATG-037 has also exhibited compelling best-in-class potential in clinical studies, with encouraging efficacy data in patients with CPI-resistant melanoma and NSCLC. During the reporting period, we disclosed the preclinical data of ATG-201 (CD19 x CD3 TCE with masking via steric hindrance) in NHP models. ATG-201 is being developed for the treatment of autoimmune diseases and is expected to enter clinical development in Q4 2025. On the commercialization and operational front, XPOVIO® delivered a robust 70.6% period-over-period revenue growth, while sales and administrative expenses declined significantly year-over-year, validating the effectiveness of our two-pronged strategy that centers around innovation and operational efficiency. Looking ahead, we will strive to accelerate the development and commercialization of our key assets, in efforts to deliver breakthrough therapies to patients worldwide and generate sustainable long-term value for our investors." 【 Business Updates】 1. Key Clinical Assets ATG-022 (CLDN18.2 Antibody-Drug Conjugate) Updated Data from the Ongoing Phase I/II CLINCH Study: ATG-022 demonstrated significant clinical efficacy and a favorable safety profile in patients with gastric/gastro-esophageal junction adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels. In 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 40% (12/30), including 1 complete response (CR), with a disease control rate (DCR) of 90% (27/30), a median progression-free survival (mPFS) of 6.97 months, a 6-month PFS rate of 51.1%, a 9-month overall survival (OS) rate of 82.7%, and a 12-month OS rate of 66.2%. The 1.8 mg/kg dose cohort achieved an ORR of 40% (10/25), including 1 CR, and a DCR of 84% (21/25). Low and ultra-low CLDN18.2 expressors (IHC 2+ ≤ 20%) who were treated at the efficacious dose range of 1.8-2.4 mg/kg achieved an ORR of 33.3% (6/18), including 1 CR, and a DCR of 50% (9/18). To date, three patients in the study have achieved CR during treatment, with one case of CR observed in each of the three cohorts (i.e., both dose levels in the CLDN18.2 moderate-to-high expressor cohorts and the CLDN18.2 low and ultra-low expressor cohort). Breakthrough Therapy Designation: ATG-022 was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of patients with CLDN18.2-positive, HER2-negative unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least two prior lines of therapy. Advancing Clinical Development in Gastric Cancer Across First- to Third-Line Settings: Antengene is currently conducting a Phase II dose-expansion study of ATG-022 in the Mainland of China and Australia. The company will continue to advance the clinical development of ATG-022 in gastric cancer in first- to third-line settings, including first-line treatment with ATG-022 in combination with pembrolizumab and chemotherapy (CAPOX/FOLFOX); second-line treatment with ATG-022 in combination with pembrolizumab; and third-line treatment with ATG-022 monotherapy. This strategy covers patients with a wide spectrum of CLDN18.2 expression levels, including moderate-to-high expressors (2+ >20%) and low and ultra-low expressors (2+ ≤20%). In addition, the ongoing clinical study includes a basket trial cohort including multiple tumor types. In preliminary data from patients with a certain subtype of gynecologic tumor, all 7 evaluable patients achieved tumor shrinkage, indicating significant clinical potential of ATG-022 in other CLDN18.2-positive tumors. Currently, this cohort continues to enroll patients. ATG-037 (Oral CD73 Small Molecule Inhibitor) Updated Data from the Ongoing Phase I/II STAMINA Study: Following the initiation of a global clinical collaboration with MSD, Antengene is evaluating ATG-037 in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with checkpoint inhibitor (CPI)-resistant melanoma and non-small cell lung cancer (NSCLC). As of July 24, 2025, data from 25 evaluable patients (11 with melanoma and 14 with NSCLC) showed an ORR of 28% (7/25) and a DCR of 84% (21/25). The melanoma subgroup with majority of patients with double resistance to both anti-PD-1 and anti-CTLA-4 antibodies demonstrated particularly notable efficacy, with an ORR of 36.4%, a DCR of 100%, including 1 CR and 3 partial responses (PRs). In the NSCLC subgroup, the ORR was 21.4%, the DCR was 71.4%, including 3 PRs. It is worth noting that the responses demonstrated impressive durability, with 1 patient in CR demonstrated durable response and has been on the trial for over 32 months, 2 patients with durable PR and has been on the trial for over 15 months, and 1 patient with stable disease (SD) has been on the trial for over 28 months. These data highlight the durable antitumor activity of this combination regimen in CPI-resistant patients. The Phase II STAMINA dose optimization and dose expansion study is currently progressing smoothly in China and Australia. ATG-031 (CD24-targeting macrophage activator) Ongoing PERFORM study: ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody that has entered clinical trials for cancer treatment in the U.S. ATG-031 works by blocking the CD24-Siglec10 pathway and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center, four renowned cancer centers in the U.S. The Phase I PERFORM study is progressing in the U.S. 2. The TCE Platform and Preclinical/Pre-IND Assets A TCE Platform Featuring Steric Hindrance Masking: AnTenGager™ TCE is a proprietary "2+1" TCE technology 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 diseases, solid tumors and hematological malignancies indications. Antengene is seeking a range of collaborations with its global partners for AnTenGager™ TCE, through platform access, co-development, and out-licensing to accelerate the development of TCE therapeutics and maximize the value of the technology platform. ATG- 201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGagerTM TCE platform for the treatment of autoimmune diseases. Preclinical data showed that in NHP models, the repeated dosing of ATG-201 surrogate at 1mpk, 3mpk, and 6mpk dose levels was well tolerated and associated with very low cytokine release. Furthermore, this surrogate antibody can mediate complete B cell depletion in peripheral blood, spleen and lymph nodes. ATG-201 is poised to enter clinical development in the second half of 2025. Antengene will continue to advance the development of other preclinical programs, including ATG-106 (CDH6 x CD3 TCE) for the treatment of ovarian cancer and kidney cancer, ATG-110 (LY6G6D x CD3 TCE) for the treatment of microsatellite stable (MSS) colorectal cancer, and ATG-112 (ALPPL2 x CD3 TCE) for the treatment of gynecologic tumors and lung cancer. 3. Commercialized Product Mainland of China: In July 2025, XPOVIO® received approval for its third indication in the Mainland of China, bringing a new treatment option to patients with multiple myeloma (MM) who have received at least one prior therapy. Among the three approved indications of XPOVIO®, two have already been included in China's National Reimbursement Drug List (NRDL), including XPOVIO® monotherapy for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and XPOVIO® in combination with dexamethasone for the treatment of R/R MM. Taiwan Market: In February 2025, XPOVIO® received national reimbursement approval in Taiwan market, making it the fifth APAC market to secure reimbursement coverage after mainland of China, South Korea, Australia, and Singapore. ASEAN Markets: In March 2025, XPOVIO® was approved in Indonesia. To date, XPOVIO® has been approved for multiple indications in ten countries and regions across the APAC region. 【 Highlights of Financial Results】 1. Revenue From Product Sales Rose Sharply by 70.6% Period-over-Period With the steady expansion of its commercial footprint across the Asia-Pacific markets, XPOVIO® generated a sales revenue of RMB 53.2 million in the first half of 2025, which rose sharply by 70.6% period-over-period. Along with the rapid revenue growth, the company's operational efficiency continued to improve, with sales and administrative expenses declining by 34.0% and 32.8% year-over-year, respectively, demonstrating excellent cost control. 2. Strong Cash Reserves Securing the Execution of Long-Term Strategies As of the end of the reporting period, the company held RMB 794 million in cash and bank balances, which is sufficient to support existing key programs to the proof-of-clinical-concept stage, securing the execution of the company's long-term strategies. To learn more about the 2025 interim financial 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 and includes several in-house discovered programs, including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 × 4-1BB bispecific antibody), ATG-031 (CD24-targeting macrophage activator), and ATG-042 (oral PRMT5-MTA inhibitor). Antengene has also developed AnTenGager™, a proprietary T cell engager 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 diseases, solid tumors and hematological malignancies indications. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 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. 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, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED