摘要：中国上海和香港，2025年5月20日–致力于研发，生产和销售同类首款及/或同类最优血液及实体肿瘤疗法的商业化阶段领先创新生物制药公司–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）今日宣布公司已与默沙东（默沙东是美国新泽西州罗威市默克

ATG-022是德琪医药的一款CLDN18.2抗体偶联药物（ADC）；KEYTRUDA（帕博利珠单抗）是默沙东的一款PD-1抑制剂。

中国上海和香港，2025年5月20日–致力于研发，生产和销售同类首款及/或同类最优血液及实体肿瘤疗法的商业化阶段领先创新生物制药公司–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）今日宣布公司已与默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）达成一项全球临床合作，将共同开展一项旨在评估ATG-022 （CLDN18.2抗体偶联药物[ADC]）联合默沙东的PD-1抑制剂KEYTRUDA（帕博利珠单抗）用于治疗晚期实体瘤患者的临床研究。

在2025年美国临床肿瘤学会胃肠道肿瘤学术会议（ASCO GI 2025）上，德琪医药公布了其I/II期CLINCH研究的最新数据。结果显示，在CLDN18.2中高表达（IHC 2+ ≥ 20%）患者中，客观缓解率（ORR）为42.9%，疾病控制率（DCR）为95.2%；在CLDN18.2低表达（IHC 2+

ATG-022在全球研发格局中具备独特优势，已有数据支持其在胃癌中对Claudin 18.2高表达、低表达及超低表达患者均展现出有意义的疗效。这一广谱抗肿瘤活性使ATG-022相比其他CLDN18.2靶向疗法，有望为更广泛的患者群体带来治疗新选择。

KEYTRUDA为已注册商标，商标权利人为美国新泽西州罗威市Merck & Co., Inc.的子公司 Merck Sharp & Dohme LLC。

关于ATG-022

ATG-022是一款被作用于CLDN18.2这一紧密连接蛋白的抗体偶联药物（ADC），而紧密连接蛋白属于一种细胞黏附分子。在正常情况下，细胞间的紧密连接蛋白会形成调节细胞渗透性的屏障。但在肿瘤中，细胞极性变化可导致紧密连接蛋白在细胞表面异常表达。CLDN18.2的过度表达常见于胃癌、食道癌、胆管癌、胰腺癌和其他多种原发恶性肿瘤。美国食品药品监督管理局 (FDA) 授予了 ATG-022两项孤儿药资格认定，分别用于治疗胃癌和胰腺癌。

来自正在开展的CLINCH研究的数据显示，ATG-022在不同CLDN18.2表达水平的胃癌患者中，包括高表达、低表达及极低表达患者均显示出良好的临床疗效。这一广谱活性显示出ATG-022在CLDN18.2阳性肿瘤患者中具备覆盖更大治疗人群的潜力。此外，在CLDN18.2低表达患者中观察到的疗效也为治疗其他具有类似CLDN18.2表达特征的肿瘤类型带来了新的治疗前景。

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生物制药领先企业，以“医者无疆，创新永续”为愿景，德琪医药专注于血液及实体肿瘤领域的同类首款和同类最优疗法的早期研发、临床研究、药物生产及商业化，致力于通过提供突破性疗法，改善全球患者生活质量。

德琪医药现已建立起一条拥有9款从临床延展至商业化阶段的肿瘤药物资产研发管线，其中，6款产品具有全球权益，3款产品具有亚太权益。公司已在美国及多个亚太市场获得31个临床批件（IND），并在11个亚太市场递交了新药上市申请（NDA）。目前，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。

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Antengene Enters into a Global Clinical Collaboration with MSD to Evaluate ATG-022 (CLDN18.2 ADC) In Combination with KEYTRUDA (pembrolizumab)

- ATG-022 is Antengene’s CLDN18.2 antibody-drug conjugate; KEYTRUDA (pembrolizumab) is MSD’s anti-PD-1 therapy.

Shanghai and Hong Kong, PRC, May 20, 2025 — Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced it has entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced solid tumors.

At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene presented the latest data from its Phase I/II CLINCH study. Results showed anobjective response rate (ORR) of 42.9%and a disease control rate (DCR) of 95.2% in patients withmoderate to high CLDN18.2 expression (IHC 2+ ≥ 20%). Additionally, the study demonstrated anORR of 30.0% and a DCR of 50.0% in patients with low CLDN18.2 expression (IHC 2+

ATG-022 is uniquely positioned in the global landscape, with data supporting meaningful efficacy across all levels of Claudin 18.2 expression in gastric cancer, including high, low, and ultra-low expressors. This broad-spectrum activity positions ATG-022 as a promising treatment for a wider patient population compared to other CLDN18.2-targeting therapies.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ATG-022

ATG-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, and pancreatic cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATG-022, for gastric and pancreatic cancers.

Data from the ongoing CLINCH study demonstrated that ATG-022 delivers robust efficacy across all levels of CLDN18.2 expression in gastric cancer patients, including those with high, low, and ultra-low expression. This broad activity positions ATG-022 as a potential market leader, capable of addressing the largest patient population with CLDN18.2-positive tumors. Furthermore, the strong efficacy observed in patients with low CLDN18.2 expression suggests promise for treating other tumor types with similar expression profiles.

About Antengene

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of “Treating Patients Beyond Borders”.

Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. 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, with the NDA for XPOVIO (selinexor) already approved in 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.

来源：动态宝