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SHANGHAI and HONG KONG, Oct. 2, 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 it will present the latest preclinical results of its novel costimulatory T cell engager (Cos-TCE) platform in a Rapid Oral Abstract Presentation at the 2026 Society for Immunotherapy of Cancer Annual Meeting (SITC 2026), taking place from November 4th to 8th, 2026, at the Phoenix Convention Center, Phoenix, Arizona, U.S. Details of the Poster Presentation Title: A CD2-based costimulatory T cell engager platform integrating a novel CD3γε/δε-targeting antibody and steric-hindrance-based CD3 masking Abstract: 15749 Rapid Oral Abstract Presentation Presenting Author: Dr. Bing Hou, Antengene's Chief Scientific Officer Topic Selection: Rapid Oral - Basic 1 Date: Friday, November 6, 2026 Time: 12:30 PM - 01:30 PM (Eastern Time) 01:30 AM - 02:30 AM , November 7 (Beijing Time) 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 diseases, 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 35 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: [email protected] BD Contacts: Ariel Guo E-mail: [email protected] SOURCE Antengene Corporation Limited 21% more press release views with Request a Demo

中国上海和香港，2026年9月21日–致力于研发，生产和销售同类首款及/或同类最优自身免疫性疾病、实体瘤和血液瘤疗法的商业化阶段领先创新生物技术公司–德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）今日宣布，靶向CLDN18.2的抗体偶联药物（ADC）ATG-022用于治疗CLDN18.2阳性晚期胃或胃食管结合部腺癌的关键性III期CLINCH-3研究在中国完成首例患者给药。 此前，ATG-022已获中国国家药监局（NMPA）药品审评中心（CDE）授予突破性治疗品种认定，这一认定加速了公司与CDE的高效沟通，为CLINCH-3研究的快速推进奠定了重要基础。该研究目前于中国率先启动并完成首例患者给药，公司计划将其拓展为多区域临床试验（MRCT），旨在为ATG-022单药治疗CLDN18.2阳性晚期胃或胃食管结合部腺癌提供坚实的临床依据，以支持其未来的上市批准申请。 CLINCH-3研究由北京大学肿瘤医院沈琳教授作为牵头研究者。这是一项随机、对照、开放性、多中心的III期临床研究，旨在评估ATG-022对比研究者选择的治疗方案在CLDN18.2阳性晚期胃或胃食管结合部腺癌患者中的有效性和安全性。该关键性临床研究的启动基于ATG-022在I/II期CLINCH研究中取得的积极结果，该研究显示ATG-022作为单药治疗在晚期胃或胃食管结合部腺癌患者中展现出差异化的疗效与安全性特征。截至2026年6月26日，RP2D 1.8mg/kg 剂量组的ORR为46.7%（14/30），确认的ORR为40%（12/30），DCR为86.7%（26/30），mOS尚未达到（中位随访14.03个月）。在CLDN18.2低表达及极低表达患者中，有效剂量范围1.8-2.4 mg/kg组的ORR为28.6% (6/21),DCR为52.4% (11/21) 。多个患者达到完全缓解 (CR) 。安全性方面，较去年截至2025年12月25日的数据相比，1.8mg/kg剂量组的3级及以上治疗相关不良事件 (TRAE) 发生率由19.4%小幅上调至21.0%，仅9.7%患者因TRAE下调给药剂量。这些数据表明，即使经过半年多更长的持续给药随访，毒素在体内产生累积效应，1.8mg/kg剂量组的3级及以上TRAE发生率仍然保持稳定。结合其强劲的抗肿瘤活性、令人鼓舞的生存获益和良好的耐受性，这些数据使ATG-022具备成为胃或胃食管结合部腺癌领域同类最优治疗选择的潜力。 沈琳 CLINCH-3研究牵头研究者 北京大学肿瘤医院教授 “CLINCH-3研究完成首例患者给药，标志着ATG-022的临床研究迈出了重要一步。晚期胃或胃食管结合部腺癌患者仍面临较大的未满足临床需求，尤其是在现有治疗后疾病进展的情况下，治疗选择仍较为有限。I/II期研究中观察到ATG-022的抗肿瘤疗效且安全性可控，其展现出的疗效前景为ATG-022进入关键性III期临床研究提供了支持。CLINCH-3研究将为判断ATG-022能否改善CLDN18.2阳性患者的临床结局提供重要依据。我们期待以严谨、科学的态度开展这项研究，并与各位研究者和研究中心保持密切合作。” 德琪医药将继续推动为ATG-022规划的三条互补临床开发路径：CLINCH-3为ATG-022提供近期注册路径，采用优化后的RP2D 1.8 mg/kg剂量，单药用于CLDN18.2 IHC 2+ ≥ 20%的3L+胃癌/胃食管结合部腺癌患者，推动ATG-022率先在胃癌实现注册。CLINCH-2正在评估ATG-022联合标准治疗方案中的化疗及抗PD-1抗体用于1L治疗，目标覆盖从IHC 1+ ≥ 1%起的更广泛CLDN18.2阳性患者，并进一步支持1L注册，充分释放ATG-022在胃癌中的治疗潜力。与此同时，CLINCH篮子试验正推动ATG-022拓展至胃癌以外的更多瘤种，目前已在多个其他CLDN18.2阳性非胃实体瘤中观察到积极疗效。通过这一开发战略，公司旨在充分释放ATG-022的临床治疗潜力，为中国及全球患者带来具有创新性和临床价值的治疗选择。 关于德琪医药    德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）是一家以研发为驱动并已进入商业化阶段的全球领先生物技术企业，专注于开发针对重大未满足医疗需求的同类首款及同类最优疗法。德琪医药的研发管线包含多款从临床前延展至商业化阶段，重点在研候选药物包括ATG-022（CLDN18.2 抗体偶联药物）、ATG-037（口服CD73抑制剂）、ATG-101（PD-L1 x 4-1BB双特异性抗体）、ATG-125（B7-H3 x PD-L1双特异性抗体偶联药物）、ATG-207（αCD3-TGF-β双功能融合蛋白），以及多个德琪医药自主研发的AnTenGager®平台开发的T细胞衔接器（TCE）项目。 AnTenGager®是德琪医药自主研发的第二代TCE平台，具备“2+1”二价结合结构，可靶向低表达靶点，同时融合空间位阻遮蔽技术和具有快速结合/解离动力学的自主CD3序列，以降低细胞因子释放综合征（CRS）风险并提升疗效。这些技术优势使该平台在自身免疫性疾病、实体瘤和血液瘤领域具有广泛的应用前景，在研管线靶点包括CD19 x CD3（ATG-201 - B细胞介导的自身免疫性疾病；已与优时比[UCB]达成全球独家授权协议）、CDH6 x CD3（ATG-106 - 卵巢癌、肾癌；已与MPM BioImpact创立的K2 Therapeutics达成独家授权协议）、ALPPL2 x CD3（ATG-112 - 妇科肿瘤、消化系统肿瘤、膀胱癌和非小细胞肺癌）、LY6G6D x CD3（ATG-110 - 微卫星稳定结直肠癌）、GPRC5D x CD3（ATG-021 - 多发性骨髓瘤）、LILRB4 x CD3（ATG-102 - 急性骨髓性白血病和慢性骨髓性单核细胞白血病）以及FLT3 x CD3（ATG-107 - 急性骨髓性白血病）。 目前，德琪医药已在美国及多个亚太市场获得35个临床批件（IND），并在10个亚太市场获得新药上市申请（NDA）批准。其首款商业化产品希维奥®（塞利尼索片）已获得中国大陆、中国台湾、中国香港、中国澳门、韩国、新加坡、马来西亚、泰国、印度尼西亚和澳大利亚的新药上市批准，并在其中5个市场（中国大陆、中国台湾、澳大利亚、韩国和新加坡）实现医保收录。 前瞻性陈述    本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内有关任何董事或本公司意向的陈述或提述乃于本文刊发日期作出。任何该等意向均可能因未来发展而出现变动。有关这些因素和其他可能导致未来业绩与任何前瞻性声明存在重大差异的因素的进一步讨论，请参阅我们截至2025年12月31日的公司年报中描述的其他风险和不确定性，以及之后向香港证券交易所提交的文件。