Selinexor

Shanghai and Hong Kong, PRC, September 21, 2026 -- 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 first patient has been dosed in China in the pivotal Phase III CLINCH-3 study of ATG-022. ATG-022 is a CLDN18.2 antibody-drug conjugate (ADC) being evaluated for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. ATG-022 was previously granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). This designation has facilitated efficient regulatory communications and supported the rapid advancement of the CLINCH-3 study. Initiated in China with the first patient dosed and planned for expansion into a multi-regional clinical trial (MRCT), the CLINCH-3 study is intended to generate robust clinical evidence to support a future marketing approval application for ATG-022 as monotherapy for CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The CLINCH-3 study is led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator’s choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The initiation of this pivotal study is supported by encouraging results from the Phase I/II CLINCH studies, which showed that ATG-022, as monotherapy, demonstrated a differentiated robust efficacy and well tolerated safety profile in patients with advanced gastric or gastroesophageal junction adenocarcinoma. As of June 26, 2026, among patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%), in the 1.8 mg/kg dose cohort, the recommended phase 2 dose (RP2D), the ORR was 46.7% (14/30) with confirmed ORR of 40% (12/30), 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, multiple patients achieved complete responses (CR). In terms of safety, 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. Together with its robust antitumor activity, encouraging survival outcomes and favorable tolerability, these data position ATG-022 as a potential best-in-disease therapy for gastric cancer or gastroesophageal junction adenocarcinoma. Lin Shen Principal Investigator of the CLINCH-3 study Professor of Peking University Cancer Hospital “The dosing of the first patient in CLINCH-3 marks an important step in the clinical evaluation of ATG-022. Patients with advanced gastric or gastroesophageal junction adenocarcinoma continue to face substantial unmet medical needs, particularly after disease progression on existing therapies. The antitumor efficacies and manageable safety profile observed in the Phase I/II study demonstrate therapeutic potential, supporting advancement of ATG-022 into the pivotal Phase III clinical study. CLINCH-3 will provide important evidence regarding whether ATG-022 can improve clinical outcomes for patients with CLDN18.2+ disease. We look forward to conducting this study with scientific rigor and working closely with participating investigators and study centers.” Antengene will continue to advance the three complementary clinical development pathways planned for ATG‑022: CLINCH-3 provides a near-term registration pathway for ATG-022 monotherapy at the optimized RP2D 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 multiple non-gastric CLDN18.2-positive solid tumors. Through this strategy, the company aims to maximize the clinical potential of ATG-022 and bring innovative, impactful therapies to patients in China and around the world. 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.

一、公司概况赜灵生物（成都赜灵生物医药科技股份有限公司）成立于2019年4月，总部位于成都，是一家临床后期阶段的生物技术公司，由四川大学华西医院科技成果转化政策孵化的首批企业之一。公司董事长兼首席科学家陈俐娟博士为四川大学华西医院一级教授、四川大学生物治疗国家重点实验室副主任。公司致力于整合结构生物学、人工智能（AI）及临床相关疾病模型，开发具有同类首创（First-in-Class）或同类最佳（Best-in-Class）潜力的高度差异化小分子疗法，重点覆盖血液系统疾病、肿瘤、中枢神经系统（CNS）及炎症/免疫（I&I）等重大未满足临床需求的领域。公司以四川大学华西医院为重要临床与科研支撑，构建了从靶点发现、分子设计到临床开发的完整研发体系。赜灵生物为贵州百灵参股子公司，约占有15%股份，根据据赜灵生物《公司章程》第十七条第八款的约定，贵州百灵对赜灵生物今后获得上市许可的新药有最终总经销权，赜灵生物的新药研发进展与贵州百灵存在重要关联。二、研发管线与临床进展公司已建立由8项专有资产组成的管线，包括2款核心产品、2款临床阶段候选药物和4款临床前候选药物。公司已自主研发7款具有全球权益的产品，其中2个适应症进入III期注册性临床试验，多个适应症进入II期临床。１.　国内管线临床试验品种靶点适应症IND申报试验分期状态备注马来酸氟诺替尼（FM）JAK2/ FLT3/ CDK6中/高危骨髓纤维化（1L）2020年III期招募中计划招募１０５人，２０２６年２月入组第一例JAK抑制复发／难治／不耐受骨髓纤维化ＩＩｂ期招募中计划招募６４人，２０２６年４月入组第一例伴血小板减少的骨髓纤维化未在药物临床实验查询到相关临床试验真性红细胞增多症IIａ期招募中计划招募６０人，２０２５年１１月入组第一例移植物抗宿主病未在药物临床实验查询到相关临床试验甲磺酸普依司他（PM）HDACI /II复发／难治弥漫大B细胞淋巴瘤2026年III期招募中计划招募３９０人，２０２５年７月完成第一例受试者入组复发／难治外周T细胞淋巴瘤II期已完成计划招募５０人，实际入组３１人，２０２６年２月完成该试验复发／难治多发性骨髓瘤2023年Iｂ／ＩＩａ招募中计划入组１２６人，２０２４年６月完成第一例入组复发／转移性晚期实体瘤2024年Iｂ／ＩＩａ招募中单臂试验，计划入组１２０人，２０２４年５月入组第一例晚期乳腺癌未在药物临床实验查询到相关临床试验ZL-85PAPP1晚期实体瘤２０２４年１２月拿到临床批件，但未查询到药物临床试验ZL-89MEK/RAF胰腺导管腺癌／结直肠癌／胃癌临床前ZL-65NLRP3帕金森病／多发性硬化症２０２６年８月中下旬刚拿到临床批件冷吡啉相关周期性综合症2025年I期招募中计划入组１０８人，２０２６年７月入组第一例心血管－代谢性疾病／肥胖未在药物临床实验查询到相关临床试验ZL-59RIPK1神经退行性疾病临床前ZL-82JAK3特应性皮炎2024年II期招募中计划入组１１１人，２０２６年２月入组第一例类风湿性关节炎2022年I期已完成溃疡性结肠炎2022年I期已完成ZL-69PIPK2溃疡性结肠炎临床前注：甲磺酸普依司他首次IND申报是在2018年贵州百灵联合四川大学华西医院申报２.　国外管线临床试验品种靶点适应症申报时间试验分期状态备注马来酸氟诺替尼（FM）JAK／FLT３／CDK６中／高危骨髓纤维化（１L／２Ｌ）2025年I/II期未招募预计2026年11月开始，预估2028年11月完成试验ZL－６５NLRP３冷吡啉相关周期性综合症I期启动中20226年8月底正式启动，中澳临床数据包同步构建ZL－６９RIPK２溃疡性结肠炎临床前知识产权方面，公司累计获得授权发明专利20项，有21项专利正在实质性审查中。三、管线估值1、马来酸氟诺替尼III期试验对照药物是磷酸芦可替尼，2017年3月通过优先审评上市，2023年和2024年分别获批新适应症。2023年在公立医院和实体药店终端，实现了7.58亿元销售额；预计2024年销售将突破8亿元，每年预计保持有10%的增长率。芦可替尼今年底将专利到期，国内正在积极布局仿制药研发，苑东生物于2024年11月已获批上市。2、甲磺酸普依司他的适应症是复发/难治性弥漫大B细胞淋巴瘤，目前III期临床试验与塞利尼索进行头对头比较安全性和有效性。弥漫大B细胞淋巴瘤患者的5年总体生存率大约60%～70%。大约50%～60%的患者在一线治疗后可以获得并维持完全缓解；30%～40%的患者复发，通常在治疗结束后2年内复发；10%的患者为难治性疾病。查询塞利尼索2021年在中国上市，2023年已进入医保目录，正处于销售上升期，查询半年报告可知收入约1.46亿元，预计全年收入可能超过3亿元。管线峰值销售(亿)PoSrNPV(亿)关键依据马来酸氟诺替尼555%2国内竞品较多，且仿制药已上市多个品种，竞争性较高。甲磺酸普依司他355%1.2查询塞利尼索国内市场目前约3亿。本次管线估值仅依据某一个适应症和在国内市场的估值，因产品的适应症扩展和市场拓展，可能与本次估值具有较大的差距，需谨慎核实，仅供参考。四、融资进展公司成立以来已完成七轮股权融资，总额约11.78亿元人民币，投后估值较首轮融资的6.95亿元增长近四倍。仅2025年一年即完成三轮融资，主要轮次如下：l 2021年1月 天使轮：贵州百灵企业直投；l 2021年12月 A轮：融资约1.065亿元，川创投领投；l 2022年10月 A+轮：0.95亿元，源阜投资、贵州百灵参与；l 2023年11月 B轮：1.92亿元，成都科创投管理的精准医学产业创新基金领投，华金资本、策源资本、生众投资跟投，老股东川创投持续投资；l 2025年1月 B+轮：1.6亿元，投资方为杭州启明融晶、苏州启明融乾、南京五源兴致、沃依二期、合肥齐济致恒私募基金、共青城中源合华；l 2025年8月 B+轮：2.19亿元，启明创投领投，高榕创投、济峰资本、齐济投资、五源资本、中源投资跟投，四川生物医药产业集团持续加注；l 2025年11月 C轮：5.11亿元（对外口径"近6亿元"），淡明资本与启明创投共同领投，腾讯投资、蓝驰创投、建发新兴投资、上海科创基金跟投，五源资本、华金资本等老股东持续加持；l 经过多轮融资，2025年获得融资8.9亿元，投后估值约34.11亿元；2026年1月13日，公司向港交所主板递交上市申请，由Jefferies（富瑞）与中金公司担任联席保荐人。IPO募集资金将主要用于核心产品FM和PM的研发、其他管线资产研发、技术平台增强及运营资金。截止目前，未获得港股上市。五、财务状况（招股书披露）公司目前尚无产品获批上市销售，未产生产品收入。2024年其他收入及收益约1966.1万元，期内亏损9165.6万元；2025年前9个月其他收入及收益约712.6万元，期内亏损1.19亿元，亏损主要源于研发开支及赎回权负债账面值变动。截至2025年9月30日，公司持有现金及现金等价物约2.05亿元。六、小结l 公司正处于临床的创新医药小分子企业，目前有4个产品处于临床阶段，1个已拿到临床批件，3个在临床前研究阶段，公司成立于2019年，基本保持每一年拿到一个临床批件，保证研发效率。l 公司多个产品处于临床阶段，尤其是核心产品，正处于临床III期，上市时间大约是2028年，未来的不确定性、挑战性可能是公司长期承压的因素。l 公司核心产品在国内市场具有一定的挑战性，可能国际市场是公司的拓展目标，如有BD可能性，应该也是缓解公司资金压力的一个途径。l 公司经过7轮股权融资，2025年获得3轮融资，启明创投连续三轮注资，可能是公司研发成功率稳定，平台效应的溢价。l 为保证公司可持续发展，伴随着产品的上市，未来商业化平台的搭建已是必走之路，而贵州百灵的平台正是合作共赢的路径之一。资料来源：来源于公布资料，内容不构成任何投资建议。