默沙東與德琪醫藥開展全球臨牀合作，以評估CLDN18.2 ADC與帕博利珠單抗的...

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ATG-022是德琪醫藥的一款CLDN18.2抗體偶聯藥物（ADC）；KEYTRUDA（帕博利珠單抗）是默沙東的一款PD-1抑制劑。

中國上海和香港，2025年5月20日–致力於研發，生產和銷售同類首款及/或同類最優血液及實體腫瘤療法的商業化階段領先創新生物製藥公司–德琪醫藥有限公司（簡稱「德琪醫藥」，香港交易所股票代碼：6996.HK）今日宣佈公司已與默沙東（默沙東是美國新澤西州羅威市默克公司的公司商號）達成一項全球臨牀合作，將共同開展一項旨在評估ATG-022 （CLDN18.2抗體偶聯藥物[ADC]）聯合默沙東的PD-1抑制劑KEYTRUDA（帕博利珠單抗）用於治療晚期實體瘤患者的臨牀研究。

在2025年美國臨牀腫瘤學會胃腸道腫瘤學術會議（ASCO GI 2025）上，德琪醫藥公佈了其I/II期CLINCH研究的最新數據。結果顯示，在CLDN18.2中高表達（IHC 2+ ≥ 20%）患者中，客觀緩解率（ORR）為42.9%，疾病控制率（DCR）為95.2%；在CLDN18.2低表達（IHC 2+ < 20%）患者中，ORR為30.0%，DCR為50.0%。研究還顯示，ATG-022具有良好的安全性和較長的治療持續時間，未觀察到眼部或神經毒性，以及間質性肺病等不良反應。

ATG-022在全球研發格局中具備獨特優勢，已有數據支持其在胃癌中對Claudin 18.2高表達、低表達及超低表達患者均展現出有意義的療效。這一廣譜抗腫瘤活性使ATG-022相比其他CLDN18.2靶向療法，有望為更廣泛的患者羣體帶來治療新選擇。

KEYTRUDA為已註冊商標，商標權利人為美國新澤西州羅威市Merck & Co., Inc.的子公司 Merck Sharp & Dohme LLC。

關於ATG-022  

ATG-022是一款被作用於CLDN18.2這一緊密連接蛋白的抗體偶聯藥物（ADC），而緊密連接蛋白屬於一種細胞黏附分子。在正常情況下，細胞間的緊密連接蛋白會形成調節細胞滲透性的屏障。但在腫瘤中，細胞極性變化可導致緊密連接蛋白在細胞表面異常表達。CLDN18.2的過度表達常見於胃癌、食道癌、膽管癌、胰腺癌和其他多種原發惡性腫瘤。美國食品藥品監督管理局 (FDA) 授予了 ATG-022兩項孤兒藥資格認定，分別用於治療胃癌和胰腺癌。

來自正在開展的CLINCH研究的數據顯示，ATG-022在不同CLDN18.2表達水平的胃癌患者中，包括高表達、低表達及極低表達患者均顯示出良好的臨牀療效。這一廣譜活性顯示出ATG-022在CLDN18.2陽性腫瘤患者中具備覆蓋更大治療人羣的潛力。此外，在CLDN18.2低表達患者中觀察到的療效也為治療其他具有類似CLDN18.2表達特徵的腫瘤類型帶來了新的治療前景。

關於德琪醫藥  

德琪醫藥有限公司（簡稱「德琪醫藥」，香港交易所股票代碼：6996.HK）是一家以研發為驅動，並已進入商業化階段的生物製藥領先企業，以「醫者無疆，創新永續」為願景，德琪醫藥專注於血液及實體腫瘤領域的同類首款和同類最優療法的早期研發、臨牀研究、藥物生產及商業化，致力於通過提供突破性療法，改善全球患者生活質量。

德琪醫藥現已建立起一條擁有9款從臨牀延展至商業化階段的腫瘤藥物資產研發管線，其中，6款產品具有全球權益，3款產品具有亞太權益。公司已在美國及多個亞太市場獲得31個臨牀批件（IND），並在11個亞太市場遞交了新葯上市申請（NDA）。目前，希維奧（塞利尼索片）已獲得中國大陸、中國臺灣、中國香港、中國澳門、韓國、新加坡、馬來西亞、泰國、印度尼西亞和澳大利亞的新葯上市批准。

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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+ < 20%). ATG-022 also exhibited a favorable safety profile and extended treatment durations, with no observed cases of ophthalmological or neurological toxicities, nor interstitial lung disease.

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.

(德琪醫藥-B)