Chidamide

HONG KONG and FLORHAM PARK, N.J., May 22, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place from May 29 to June 2, 2026 in Chicago, USA. Results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China will be presented during a rapid oral session. The study met its primary endpoint of objective response rate (“ORR”) per RECIST 1.1, as assessed by the Independent Review Committee (“IRC”). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%, median time to response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 (95%CI: 3.7, 18.5) months, and median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months, respectively. The data supported the New Drug Application (NDA) submission to the China National Medical Products Administration (NMPA), which was accepted and granted priority review in December 2025. Additionally, further analyses of the fruquintinib’s FRESCO, FRESCO-2, FRUSICA-1 and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib spanning across a diverse range of potential tumor indications will be presented. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead Author Presentation details SPONSORED STUDIES A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas Zhi Peng, Beijing, China 4011 Rapid Oral Abstract Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Monday, June 1, 2026 1:15 PM CDT Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2 Elena Elez, Barcelona, Spain 3555 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study Kaiwei Yang, Beijing, China 4531 Poster Session: Genitourinary Cancer – Kidney and Bladder Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden Yuanyuan Qu, Shanghai, China 4533 Poster Session: Genitourinary Cancer – Kidney and Bladder Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1 Xiaotian Han, Shanghai, China e17612 Publication Only: Gynecologic Cancer INVESTIGATOR-INITIATED STUDIES Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial Jianmin Xu, Shanghai, China LBA3563 Poster Session: Gastrointestinal Cancer – Colorectal and Anal CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Yue Liu, Hangzhou, China TPS3680 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF-080/QUINTIS trial Joseph Tintelnot, Hamburg, Germany TPS3684 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety Chang Wang, Changchun, China 2631 Poster Session: Developmental Therapeutics – Immunotherapy Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study Yun Xu, Shanghai, China 3528 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC) Wenhua Li, Shanghai, China 3534 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases Mengzhou Guo, Shanghai, China 3552 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study Xiaodong Zhu, Shanghai, China 4063 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) Hao Wen, Shanghai, China 5579 Poster Session: Gynecologic Cancer Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study Wangjun Liao, Guangzhou, China e15539 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study Yifu He/Jiayu Niu, Hefei, China e15560 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer Qian Li, Nanning, China e15571 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial Wei Li, Suzhou, China e15583 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States Vasu Bansal, Kansas City, US e15713 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION) Beibei Chen, Zhengzhou, China e16033 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study Yanhong Gu, Nanjing, China e16070 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Xuetao Shi/Jingtao Zhong, Jinan, China 4136 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial Wenquan Wang, Shanghai, China 4198 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single-arm phase II clinical trial Huijuan Yang, Shanghai, China 5586 Poster Session: Gynecologic Cancer Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study Bei Xu, Shanghai, China 8119 Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study Fuxiang Zhou, Wuhan, China e16172 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study Shasha Fan, Changsha, China e16222 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study Xiang Han, Qingdao, China e20079 Publication Only: Lung Cancer – Non-Small Cell Local-Regional/ Small Cell/Other Thoracic Cancers About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib and surufatinib, the further clinical development for fruquintinib, savolitinib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, savolitinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, savolitinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Duncan Monteith / Ramin Naji +44 20 7545 8000

5月21日，“联合有爱，无双同行——西达本胺DEB研究新闻发布会”在京举行。会议聚焦由北京大学肿瘤医院朱军教授团队、上海交通大学医学院附属瑞金医院赵维莅教授团队共同主导、全国45家研究中心参与的西达本胺DEB III期临床研究成果。该研究已于4月22日发表于国际顶级医学期刊《美国医学会杂志》（JAMA）主刊。该项研究的主要研究者、淋巴瘤权威专家及微芯生物研发与高管团队深度解读了此项研究的突破性价值。 登顶JAMA 改写20年治疗空白 DEB研究是一项评估西达本胺联合R-CHOP对比R-CHOP用于初治双表达弥漫大B细胞淋巴瘤（DE-DLBCL）的随机、双盲、对照、多中心III期临床研究，交出全球首个阳性结果： 完全缓解率（CRR）提升至73%，较传统方案绝对提高11.1个百分点； 两年无事件生存率（EFS）达60.3%，疾病进展、复发与死亡风险显著降低28%。 该研究验证的“西达本胺联合R-CHOP序贯西达本胺单药维持”方案，是全球首个针对DE-DLBCL的一线治疗新策略，填补了该领域20余年的一线标准治疗空白。 对于此次登顶《JAMA》的DEB研究，与会专家一致认为，这一“中国方案”不仅改写了全球双表达弥漫大B细胞淋巴瘤的治疗规则、树立了中国原创新药在全球肿瘤精准治疗领域的新里程碑，更将直接反哺国内外临床指南更新，推动该疾病从“经验性高危分层”迈向“机制驱动性靶向干预”，为全球高危DLBCL个体化治疗贡献普适性的中国智慧。 “这是我们这一代医生的使命” 朱军教授 DEB研究牵头专家、北京大学肿瘤医院 “双表达弥漫大B淋巴瘤是全球共同关注的难题，也是我们这一代中国医生和中国药企的使命。”朱军教授坦言，过去20多年全球没有公认的一线标准。DEB研究首次为这一难治亚群交出阳性答案，让中国患者迎来更高治愈、更长生存的希望。 基于中期分析的优异数据，2024年4月国家药监局优先批准该适应症，同年年底纳入国家医保目录——从获批到患者用得上、用得起，仅用不到一年时间。“这打破了‘研究结束、审批启动、患者用药’的传统壁垒，实现了科研突破与临床获益的无缝衔接。这就是中国的担当与速度，中国的创新与温度。” 目前，该方案已连续两年（2025版、2026版）以1级推荐1A类证据纳入CSCO淋巴瘤诊疗指南，从国家级中心到基层医院同步可及，成为中国规范化诊疗的标准方案。 “十年坚守，从跟跑到领跑” 赵维莅教授 DEB研究牵头专家、上海交通大学医学院附属瑞金医院 “2017年，我们与微芯生物共同确立‘用中国原创新药破解全球难题’的初心。我们没有沿袭国际既往研究路径，而是锚定淋巴瘤的生物学特性，结合西达本胺的表观遗传调控机制，设计了完全原创的方案。”赵维莅教授回顾了跨越十年的征程。 团队在II期研究中发现，西达本胺联合方案对DE-DLBCL的卓越疗效，并通过转化医学证实了其三重协同机制。六年前首例患者入组，正值疫情期间，团队通过冷链跨城投药、远程随访、线上监察等创新模式，26个月如期完成全国45家研究中心共423例患者的入组。“科学坚守，就是对患者最好的承诺。”这条“临床—基础—临床”的全链条模式，将持续推动西达本胺在更多淋巴瘤亚群中的应用。 赵教授说：“回望中国创新药发展之路，我们曾长期跟跑，表观遗传这一前沿赛道更是鲜有中国原创的声音。今天，我们以中国方案破解全球医疗难题，重塑了双表达淋巴瘤患者的治疗版图，以中国创新贡献全人类健康。” 表观遗传硬科技 从机制突破到临床可及 微芯生物联合创始人宁志强博士用“交响乐”阐释表观遗传调控机制：“遗传是乐谱，表观遗传是指挥家。西达本胺能让肿瘤细胞内混乱的‘演奏’重回正轨。” 湖南省肿瘤医院周辉教授指出：“全球首个”的核心在于精准人群与阳性结果的结合。DEB研究首次证实西达本胺联合方案能显著改善患者生存，意味着从“无解”到“有方”的跨越。 华中科技大学同济医学院附属协和医院张利玲教授给出患者管理建议：DEB研究在常规6周期住院治疗后，24周维持治疗仅需口服西达本胺，无需住院。通过在线平台“出院不离管”，将疗效转化为长期获益。 大连医科大学附属第二医院孙秀华教授分享中心经验：“新冠病毒给我们设下了重重障碍，但是我们团队齐心协力，为每一位患者点亮一盏通向康复的绿灯。” 这虽只是45家中心的一个缩影，却凝聚了每一位研究者的坚守。 中山大学附属肿瘤医院蔡清清教授指出：本次研究由中国学者主导设计、基于中国人群特征、采用中国原创药物，用高质量数据回答了全球难题。中国方案的价值不在于“中国”二字，而在于真正解决世界性难题。 答记者问 从检测到可及，从理想到未来 福建协和医院沈建箴教授分享了入组43例患者的初心：“高水平临床研究的价值，不仅在于发表论文，更在于改变治疗实践，惠及一代又一代患者。” 关于完全缓解率提升11%的临床意义，景红梅教授与朱军教授指出：完全缓解是治愈的前提。11.1%的绝对提升，意味着每100位患者中多出11位能够获得完全缓解，为这11%的患者增加了治愈的可能和希望。同时专家也提醒，突破不等于万能，疾病控制同样具有价值。 关于双表达检测，朱军教授介绍：诊断关键在于检测MYC和BCL2两种蛋白的表达。目前免疫组化检测已非常规范，国内大多数三甲医院均可常规开展，三五天即可出结果，标准化检测加上培训与质控，能够推进规范化诊疗进程。 微芯生物总经理黎建勋表示：“做创新药是高投入、长周期、高风险的事业。微芯坚持了25年，依靠对临床未满足需求的坚定聚焦、科学家的远见以及严谨预算规划。”未来，微芯将持续深耕表观遗传领域，推进西达本胺在结直肠癌等适应症的开发，并依托AI赋能早期研发平台，在肿瘤、代谢、自身免疫及神经退行性疾病等领域，催生更多First-in-class原创新药。 朱军教授展望道：“未来已来，已经不是设想。表观遗传联合免疫靶向治疗的探索已在其他肿瘤中起步。西达本胺通过调控肿瘤微环境与免疫监视，与其他药物及免疫药物具有增效协同作用，有望为淋巴瘤及其他肿瘤类型带来新的治疗选择。我们用了十多年走到今天，证明这一方向正确，将继续深耕，争取贡献更多中国方案。” 从打破外资垄断、填补全球空白，到登顶JAMA、改写国际规则，中国医者以原创新药为核心、临床研究为支撑、患者获益为目标，构建起“中国原创、中国证据、中国标准、全球引领”的创新闭环。正如朱军与赵维莅教授所言，全球双表达这一难治亚群终于迎来了更多治愈、更长生存的希望——中国方案以创新的速度与温度破解了全球医疗难题，重塑了DE-DLBCL患者的治疗版图。 Mayo Clinic临床血液学专家Stephen Ansell教授在JAMA同期述评中高度评价，认为这一成果为双表达淋巴瘤提供了优选联合方案，肯定了西达本胺单药维持治疗的获益价值，并寄望其未来惠及全球患者。 科学坚守，是对患者最好的承诺；医者初心，让治愈之光照亮更多生命。 1.本文仅供医疗专业人士交流及分享，不可被视作治疗建议。 2.微芯生物不推荐任何未获批的药品和/或适应症使用。 3.不同个体的治疗方案和用药获益存在差异，如有不适，应及时就医并遵从医疗卫生专业人士的意见与指导。 往期推荐 西格列他钠、西达本胺在澳门获批！ EHA 2026抢先看 DEB研究成果在JAMA发表