Selinexor

SHANGHAI and HONG KONG , Oct. 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 it has presented the latest clinical results from the Phase II study of Claudin 18.2 antibody-drug conjugate (ADC) ATG-022 and the Ib/II study of oral CD73 small-molecule inhibitor ATG-037 in poster presentations at the 2026 European Society for Medical Oncology Annual Congress (ESMO 2026). Details of the Poster Presentations ATG-022 (Claudin 18.2 Antibody-Drug Conjugate) Title: ATG-022, a Claudin 18.2 ADC, in Advanced Gastric and Gastroesophageal Junction Cancer (CLINCH): Phase 2 Results Poster Number: 2886P Date: October 25, 2026 Time: 12:00PM-12:45PM (Central European Time) 7:00PM-7:45PM (Beijing Time) Study Overview: ATG-022 is a CLDN18.2-targeting ADC comprising a humanized antibody (sub-nM affinity) linked to vc-MMAE. The CLINCH study is a Phase Ⅰ/Ⅱ clinical trial conducted in patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC), designed to evaluate the safety, tolerability and preliminary efficacy of ATG-022 monotherapy. The study included a dose escalation phase and a dose expansion/optimization phase. In the dose escalation phase, patients with advanced solid tumors were enrolled regardless of CLDN18.2 expression and received ATG-022 once every three weeks at doses of 0.3–3.0 mg/kg (Q3W). In the Phase Ⅱ dose expansion, CLDN18.2-positive (IHC 1+, ≥1%) patients were enrolled to receive ATG-022 monotherapy at 1.8 mg/kg or 2.4 mg/kg. The efficacy endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), evaluated per RECIST 1.1 criteria, and overall survival (OS). Results: As of October 12, 2026, a total of 82 patients with GC/GEJC from Australia and China received treatment in the Phase Ⅱ dose expansion phase. This poster highlights data from the 1.8 mg/kg cohort: among the 31 patients, 30 were efficacy evaluable, with an ORR of 46.7%, a DCR of 86.7%, and a mPFS of 5.6 months. Notably, the mOS for the 1.8 mg/kg cohort had not yet been reached after a median follow‑up of 17.4 months, and the 18-month OS rate of intention to treat （ITT）population was 54.8%. In terms of safety, the incidence of Grade ≥3 TRAEs in the 1.8 mg/kg cohort was 25.8%, the incidence of serious TRAEs was 12.9%, and 12.9% of patients experienced dose interruption due to TRAEs. No individual Grade ≥3 TRAE exceeded 10% incidence in the 1.8 mg/kg cohort. Conclusion: These findings demonstrate that ATG-022 monotherapy delivers differentiated efficacy and a favorable safety pro patients with GC/GEJC. Together with its prior Breakthrough Therapy Designation, these results lay an important foundation for the rapid advancement of CLINCH-3, the pivotal Phase III study of ATG-022. The study has received IND approval from the National Medical Products Administration (NMPA) of China, and the 1.8 mg/kg dose has been recommended for the trial. In addition, the Company is concurrently conducting the CLINCH-2 study, which evaluates ATG-022 in combination with standard-of-care chemotherapy and an anti-PD-1 antibody for 1L treatment, targeting the broadest CLDN18.2-positive population starting from IHC 1+ ≥1%. Additional data will be presented at future international scientific congresses. ATG-037 (Oral CD73 Small Molecule Inhibitor) Title: Efficacy and safety of ATG-037, an oral CD73 inhibitor, plus pembrolizumab in patients with checkpoint inhibitor (CPI) resistant melanoma: Updated results from the STAMINA-01 trial Poster Number: 2087P Date: October 24, 2026 Time: 12:00PM-12:45PM (Central European Time) 6:00PM-6:45PM (Beijing Time) Study Overview: The immunosuppressive adenosine pathway plays a key role in mediating resistance to PD-(L)1 therapies across tumor types. Preclinical studies have demonstrated synergy when combining CD73 or A2AR blockade with PD-1 or CTLA-4 inhibition. ATG-037 is an oral small-molecule CD73 inhibitor developed by Antengene, designed to achieve complete enzyme inhibition without the "hook effect". This poster reports updated efficacy and safety data from CPI-resistant melanoma patients receiving ATG-037 in combination with pembrolizumab. As of 28 April 2026, 25 patients with CPI-resistant melanoma received ATG-037 (60–600mg BID) in combination with pembrolizumab (200mg Q3W). Efficacy was assessed via RECIST v1.1. CD73 expression was evaluated by immunohistochemistry (IHC) on tumor or immune cells. Results: Among 23 evaluable patients, ATG-037 in combination with pembrolizumab demonstrated an ORR of 21.7% (1 CR, 4 PR) and a DCR of 95.6%. Clinical activity was enriched in patients with high CD73 expression (IHC ≥50% on tumor or immune cells), achieving an ORR of 33.3% (4/12). The median PFS was 4.4 months (95% CI: 3.7–11.9), and median DOR was not reached. Notably, one patient with cutaneous melanoma achieved an ongoing CR exceeding 167 weeks. TEAEs and TRAEs occurred in 88% and 52% of patients, respectively. Grade ≥3 TRAEs were limited to a single patient (4%) who experienced Grade 3 diarrhea. The most common TRAEs of any grade included diarrhea (24%), rash (20%), and pruritus (16%). Conclusion: ATG-037 in combination with pembrolizumab demonstrates robust, durable efficacy and a favorable safety pro heavily pretreated, CPI-resistant melanoma. CD73-enriched responses validate the mechanism, supporting further evaluation in CPI-resistant populations. 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: peter.qian@antengene.com BD Contacts: Ariel Guo E-mail: ariel.guo@antengene.com View original content to download multimedia: SOURCE Antengene Corporation Limited

中国上海和香港，2026年10月26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，公司以壁报形式在2026年欧洲肿瘤内科学会年会（ESMO 2026）上公布了Claudin 18.2抗体偶联药物ATG-022的II期临床研究和口服CD73小分子抑制剂ATG-037的Ib/II期临床研究的最新研究成果。 壁报详细信息 ATG-022（Claudin 18.2抗体偶联药物） 标题：Claudin 18.2抗体偶联药物ATG-022在晚期胃或胃食管结合部癌的II期临床研究（CLINCH）结果 壁报编号：2886P 日期：2026年10月25日 时间：7:00PM-7:45PM（北京时间）          12:00PM-12:45PM（中欧时间) 研究介绍： ATG-022是一款靶向CLDN18.2的抗体偶联药物（ADC），由亚纳摩尔级亲和力的人源化抗体与vc‑MMAE偶联而成。CLINCH研究是一项在晚期胃或胃食管结合部腺癌患者中开展的Ⅰ/Ⅱ期临床研究，旨在评估ATG-022单药治疗的安全性、耐受性和初步疗效。研究分为剂量爬坡和剂量扩展/剂量优化两个阶段。在剂量爬坡阶段，研究纳入晚期实体瘤患者，入组不限CLDN18.2表达水平，给药剂量为0.3–3.0 mg/kg（每3周一次）；进入Ⅱ期剂量扩展阶段后，研究纳入CLDN18.2表达阳性（IHC 1+，≥1%）的患者，分别接受1.8 mg/kg或2.4 mg/kg剂量的ATG‑022单药治疗。疗效终点包括基于RECIST 1.1标准评估的客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）以及总生存期（OS）。 研究结果： • 截至2026年10月12日，Ⅱ期剂量扩展阶段共有82例来自澳大利亚与中国的GC/GEJC患者接受治疗。本次壁报重点公布了1.8 mg/kg剂量组的研究数据：该组共31例患者，其中30例疗效可评估患者的ORR为46.7%，DCR为86.7%，mPFS为5.6个月。值得注意的是，1.8 mg/kg剂量组的mOS仍未达到（中位随访17.4个月），意向治疗（ITT）人群的18个月总生存率为54.8%。 • 安全性方面，1.8 mg/kg剂量组的 ≥3级TRAE发生率为25.8%，严重 TRAE发生率为12.9% ，因TRAE导致给药中断的比例为12.9%，没有任何一项 ≥3级TRAE的发生率超过10%。 结论： • 上述结果显示，ATG-022作为单药治疗在GC/GEJC患者中展现出差异化的疗效与良好的安全性特征。这些研究结果以及此前获得的突破性治疗品种认定为ATG-022关键性Ⅲ期研究CLINCH-3研究的快速推进奠定了重要基础，目前该研究已获中国国家药品监督管理局（NMPA）批准IND，1.8 mg/kg剂量被推荐用于后续研究。 • 此外，公司正同步开展ATG-022联合标准治疗方案中的化疗及抗PD-1抗体用于1L治疗的CLINCH-2研究，目标覆盖从IHC 1+ ≥ 1%起的更广泛CLDN18.2阳性患者，并将在后续的国际学术会议上公布更多数据。 ATG-037（口服CD73小分子抑制剂） 标题：口服CD73抑制剂ATG-037联合帕博利珠单抗治疗免疫检查点抑制剂（CPI）耐药黑色素瘤患者的疗效与安全性：STAMINA-01研究结果更新 壁报编号：2087P 日期：2026年10月24日 时间：6:00PM-6:45PM（北京时间）          12:00PM-12:45PM（中欧时间） 研究介绍： • 免疫抑制性腺苷通路是介导多瘤种PD-(L) 1治疗耐药的关键通路。临床前研究证实，CD73或A2AR阻断剂与PD-1、CTLA-4抑制剂联用具备协同抗肿瘤效应。ATG-037是德琪医药自主开发的一款口服CD73小分子抑制剂，可实现对靶点酶的完全抑制，且无“钩状效应”。 • 本次壁报公布了CPI耐药黑色素瘤患者接受ATG-037联合帕博利珠单抗治疗的更新疗效与安全性数据。截至2026年4月28日，共有25例CPI耐药黑色素瘤患者接受ATG-037（60–600mg每日2次）联合帕博利珠单抗（200mg，每3周一次）方案治疗，采用RECIST v1.1标准评估疗效，并通过免疫组化（IHC）检测肿瘤细胞或免疫细胞上的CD73表达水平。 研究结果： • 在23例疗效可评估患者中，ATG-037联合帕博利珠单抗方案的ORR为21.7%，包含1例完全缓解（CR）、4例部分缓解（PR），DCR为95.6%。在CD73高表达人群（肿瘤细胞或免疫细胞IHC 表达≥50%）中，抗肿瘤活性更突出，ORR为33.3%（4/12）。 • 中位无进展生存期（PFS）为4.4个月（95%置信区间：3.7–11.9），中位缓解持续时间（DOR）尚未达到。值得关注的是，1例皮肤黑色素瘤患者获得持续CR，缓解时长已超167周。 • 所有治疗期间不良事件（TEAEs）发生率为88%，治疗相关不良事件（TRAEs）发生率52%。仅1例患者（4%）发生 ≥3级治疗相关不良事件，该不良事件为3级腹泻。最常见的各等级治疗相关不良事件包括腹泻（24%）、皮疹（20%）和瘙痒（16%）。 结论： ATG-037联合帕博利珠单抗在经多线治疗、CPI耐药黑色素瘤人群中展现出强效且持久的疗效与良好的安全性特征。CD73高表达人群的应答结果则进一步验证了该药物的作用机制，支持其后续在CPI耐药患者群体中继续开展相关研究。 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。