Capecitabine

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., April 24, 2025 (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 including savolitinib, fruquintinib and surufatinib, which will be presented at the upcoming American Association of Cancer Research (AACR) Annual Meeting 2025, taking place on April 25-30, 2025 in Chicago, Illinois. Details of the presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIESTargeting KEAP1/NRF2 signaling sensitizes KRAS-driven NSCLC to KRAS inhibitorsXianwen Yang, HUTCHMED, Shanghai, China4450Poster Session (PO.ET03.04)Tuesday, April 29, 2025SAVANNAH: Clearance of plasma EGFRm in patients with EGFRm MET-overexpressed (OverExp) and/or -amplified (Amp) NSCLC post-osimertinib (osi) treated with savolitinib (savo) + osiJonathan W. Riess, University of California, UC Davis Comprehensive Cancer Center, CA, USLB416Late-Breaking Poster Session(LBPO.CL04)Wednesday, April 30, 2025A phase I open-label positron-emission tomography study to determine brain exposure of [11C]savolitinib in healthy volunteersKowser Miah, AstraZeneca, Waltham, MA, US4353Poster Session (PO.ET07.01)Tuesday, April 29, 2025 INVESTIGATOR-INITIATED STUDIESA multi-cohort study of treatment regimens for metastatic colorectal cancer (mCRC): Subgroup analysis of sequential therapy between fruquintinib and regorafenibWangxia Lv, Cancer Hospital of the University of Chinese Academy of Sciences/ Zhejiang Cancer Hospital, Hangzhou, ChinaCT085Poster Session (PO.CT02.03)Monday, April 28, 2025Phase Ib/II study of fruquintinib (F) combined with capecitabine (C) as maintenance therapy (MT) for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) after first-line treatment with cetuximab combined with chemotherapyLin Yang/ Kai Ou, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaCT222Poster Session (PO.CT02.02)Tuesday, April 29, 2025Tyrosine kinase inhibitor (TKI) plus PD-1 blockade in TKI-responsive MSS/pMMR metastatic colorectal adenocarcinoma (mCRC): Results of a multicenter, phase II trial (TRAP)Jingdong Zhang/ Qian Dong, Liaoning Cancer Hospital & Institute, Cancer Hospital of Dalian University of Technology, Shenyang, China6002Poster Session (PO.CL08.03)Tuesday, April 29, 2025Efficacy and mechanism of radiotherapy combined with fruquintinib and tislelizumab in mCRCXianglin Yuan, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China1828Poster Session (PO.ET08.02)Monday, April 28, 2025Prediction of surufatinib treatment outcome in advanced grade 3 neuroendocrine tumors (NET G3) patientsJing Hao, Qilu Hospital of Shandong University, Jinan, ChinaCT084Poster Session (PO.CT02.03)Monday, April 28, 2025Surufatinib and sintilimab in combination with capecitabine for previously treated metastatic small bowel adenocarcinoma or appendiceal carcinoma: A single-arm, single-center, phase Ib/II trialYanhong Deng/ Xiaoyu Xie, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, ChinaCT033Poster Session (PO.CT01.03)Monday, April 28, 2025GPR34-driven damage-response macrophages underlie therapeutic resistance to surufatinibSong Gao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China6818Poster Session (PO.ET07.02)Wednesday, April 30, 2025Efficacy and mechanism of surufatinib combination with PD-1 monoclonal antibody and chemotherapy for the treatment of pancreatic cancer with liver metastasis in animal modelsGuanghai Dai/ Ru Jia, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China6824Poster Session (PO.ET07.02)Wednesday, April 30, 2025Efficacy and mechanistic insights of Shengyang Qushi Decoction in managing surufatinib-associated diarrheaHuangying Tan, China-Japan Friendship Hospital, Beijing, China1043Poster Session (PO.PR02.03)Sunday, April 27, 2025 About Lung Cancer Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.1 More than a third of the world’s lung cancer patients are in China. Lung cancer is broadly split into non-small cell lung cancer (“NSCLC”) and small cell lung cancer, with NSCLC accounting for about 80% of cases.2 Approximately 10-15% of NSCLC patients in the US and Europe and 30-40% of patients in Asia have an epidermal growth factor receptor (“EGFR”) mutation (“EGFRm”).3,4,5,6 Approximately 2-3% of NSCLC patients have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene.7 About Savolitinib and MET Aberrations in Lung Cancer Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an essential role in normal cell development.8 Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is a known mechanism of acquired resistance to EGFR TKIs.8,9 The prevalence of MET depends on the sample type, detection method and assay cut-off used. Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines. About Savolitinib in combination with TAGRISSO® (osimertinib) Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO® is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with savolitinib in combination with TAGRISSO® has been studied extensively in these patients in the TATTON (NCT02143466) and SAVANNAH (NCT03778229) studies. The encouraging results led to the initiation of several Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836). This combination represents a promising chemo-free oral treatment strategy to address mechanisms of resistance in this advanced setting. Positive data from the SACHI randomized Phase III trial has led to the filing of a second New Drug Application (“NDA”) in China. Strong data from the SAVANNAH single-arm Phase II study was recently presented at the European Lung Cancer Congress (ELCC) in March 2025 demonstrated high, clinically meaningful and durable objective response rate (ORR), with consistent safety results. The SAFFRON randomized Phase III trial is progressing. Following AstraZeneca’s consultation with the US Food and Drug Administration (“FDA”), we look forward to completing the SAFFRON trial as soon as possible to support potential US and other global registration filings. SACHI: The SACHI China Phase III trial met the primary endpoint of progression free survival (PFS) during its interim analysis towards the end of 2024 and a NDA was accepted and granted Breakthrough Therapy Designation and Priority Review status in China in December 2024. SACHI evaluated the combination of savolitinib and TAGRISSO® for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC after progression on EGFR TKI compared to platinum-based doublet chemotherapy. Results will be presented at an upcoming scientific conference. SAFFRON: In 2023, savolitinib and TAGRISSO® received Fast Track Designation from the US FDA in this setting. The global SAFFRON Phase III trial is currently ongoing to assess the savolitinib plus TAGRISSO® combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO®. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH. 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: www.hutch-med.com 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 osimertinib, capecitabine, sintilimab or tislelizumab, 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.comBen Atwell / Alex Shaw+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Freddy Crossley / Rupert Dearden+44 20 7886 2500 HSBCJoint BrokerSimon Alexander / Alina Vaskina / Arnav Kapoor+44 20 7991 8888 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 ________________________REFERENCES 1World Health Organization. International Agency for Research on Cancer. All cancers fact sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf. Accessed November 2022.2American Cancer Society. What is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed November 2022.3Knight SB, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9): 170070. DOI: 10.1098/RSOB.170070.4Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. DOI: 10.1200/JCO.2010.31.8923.5Zhang Y, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48). DOI: 10.18632/oncotarget.12587.6Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12. PMID: 24294366.7Vuong HG, et al. Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer – A systematic review and meta-analysis. Lung Cancer. 2018; 123: 76-82. DOI: 10.1016/j.lungcan.2018.07.006.8Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074). DOI: 10.1038/s41467-021-24367-3.9Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. Journal of Hematology & Oncology. 2019;63. DOI: 10.1186/s13045-019-0759-9.

2025年4月24日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢及心血管、眼科等重大疾病领域创新药物的生物制药公司，今日宣布，将在 2025年美国临床肿瘤学会（ASCO）年会上公布肿瘤创新管线的一系列临床数据，包括IBI363（PD-1/IL-2α-bias）和IBI343(CLDN18.2 ADC)的多项口头报告。本届 ASCO 年会将于当地时间2025年5月30日-6月3日在美国芝加哥举办。信达生物制药集团高级副总裁周辉博士表示：“很高兴在本次ASCO大会上，IBI363（PD-1/IL-2α-bias）开发的第一批三大适应症黑色素瘤、肠癌、非小细胞肺癌的临床研究均被接收为口头报告，代表了下一代PD-1双抗肿瘤免疫疗法引起了全球的广泛关注。同时IBI343（CLDN18.2 ADC）胰腺癌研究继去年12月ESMO Asia口头报告之后，再次以口头报告登上ASCO舞台。基于本次亮相的PoC成熟数据，我们有信心并计划推进IBI363和IBI343的多个注册临床开发。同时我们更多ADC管线将在ASCO汇报临床数据。作为少数拥有‘IO+ADC’技术平台和充沛管线储备的生物制药企业，信达生物将在癌症治疗领域持续取得突破，致力于为医生和患者提供更创新、有效和安全的治疗手段及方案。”临床研究结果摘要信息如下：口头报告摘要标题：首创新型PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363在免疫治疗后的晚期肢端及黏膜黑色素瘤患者中的疗效与安全性摘要编号：2502会议类型：口头报告会议环节：开发中的疗法-免疫治疗展示时间：2025年5月31日 下午3:00-6:00（美国中部时间）演讲者：郭军教授，北京大学肿瘤医院摘要标题：IBI363单药或联合贝伐珠单抗在晚期结直肠癌患者中的疗效与安全性摘要编号：104会议类型：口头报告会议环节：临床科学研讨会-将“冷”肿瘤变“热”展示时间：2025年6月1日 上午9:45-11:15（美国中部时间）演讲者：林振宇教授，华中科技大学同济医学院附属协和医院摘要标题：首创新型PD-1/IL-2α-bias双特异性抗体IBI363在免疫治疗后的晚期非小细胞肺癌（NSCLC）患者中的应用摘要编号：8509会议类型：口头报告会议环节：临床科学研讨会-双靶点，同一目标：双特异性抗体在胸部恶性肿瘤中的潜力展示时间：2025年6月3日 上午9:45-11:15（美国中部时间）演讲者：周建娅教授，浙江大学医学院附属第一医院摘要标题：Claudin18.2（CLDN18.2）在胰腺导管腺癌（PDAC）中的表达与疗效：IBI343的I期剂量扩展队列研究结果摘要编号：4017会议类型：口头报告会议环节：胃肠道肿瘤-胃食管、胰腺及肝胆肿瘤展示时间：2025年6月2日 上午11:30-下午1:00（美国中部时间）演讲者：虞先濬教授，复旦大学附属肿瘤医院摘要标题：信迪利单抗（抗PD-1）联合异环磷酰胺、卡铂及依托泊苷（ICE）二线治疗经典霍奇金淋巴瘤（cHL）：一项多中心、随机、对照、双盲III期研究（ORIENT-21）摘要编号：7007会议类型：口头报告会议环节：血液系统恶性肿瘤-淋巴瘤与慢性淋巴细胞白血病展示时间：2025年5月30日 下午2:45-5:45（美国中部时间）演讲者：刘鹏教授，中国医学科学院肿瘤医院摘要标题：短程放疗联合信迪利单抗和CAPOX作为局部晚期直肠癌的全程新辅助治疗：一项前瞻性、随机对照试验（SPRING-01）摘要编号：3519会议类型：口头报告会议环节：胃肠道肿瘤-结直肠和肛门展示时间：2025年6月1日 上午11:30 -下午1:00 P（美国中部时间）演讲者：靖昌庆医生，山东省立医院摘要标题：动态肿瘤循环DNA驱动的鼻咽癌风险适应性系统治疗（卡培他滨/信迪利单抗）：EP-STAR试验摘要编号：6010会议类型：口头报告会议环节：临床科学研讨会-生物标志物驱动的适应性治疗：头颈癌的新视野展示时间：2025年6月2日下午3:00-4:30（美国中部时间）演讲者：孙颖医生，中山大学肿瘤防治中心壁报摘要标题：PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363在黏膜及肢端黑色素瘤中的多中心、随机、对照、开放标签II期研究：进行中的研究摘要编号：TPS9594会议类型：壁报会议环节：黑色素瘤/皮肤癌展示时间：2025年6月1日 上午9:00-12:00（美国中部时间）演讲者：连斌教授，北京大学肿瘤医院摘要标题：抗HER2抗体-药物偶联物IBI354在局部晚期不可切除或转移性卵巢癌患者中的应用：I期研究更新结果摘要编号：5565会议类型：壁报会议环节：妇科肿瘤展示时间：2025年6月1日 上午9:00-12:00（美国中部时间）演讲者：舒锦教授，重庆大学附属肿瘤医院摘要标题：IBI354（抗HER2抗体-药物偶联物[ADC]）在HER2阳性乳腺癌（BC）及其他实体瘤患者中的应用：I期研究更新摘要编号：1029会议类型：壁报会议环节：乳腺癌-转移性展示时间：2025年6月2日 上午9:00-12:00（美国中部时间）演讲者：Charlotte Lemech教授，Scientia临床研究中心摘要标题：抗TROP2抗体-药物偶联物（ADC）IBI130在晚期三阴性乳腺癌（TNBC）及其他实体瘤患者中的安全性与疗效：I期研究结果摘要编号：1102会议类型：壁报会议环节：乳腺癌-转移性展示时间：2025年6月2日 上午9:00-12:00（美国中部时间）演讲者：吴凡教授，福建省肿瘤医院摘要标题：抗Claudin18.2（CLDN18.2）抗体-药物偶联物（ADC）arcotatug tavatecan（IBI343）在胃或胃食管结合部腺癌（G/GEJA）中的多区域、随机、对照、开放标签III期研究：进行中的研究摘要编号：TPS4201会议类型：壁报会议环节：胃肠道肿瘤-胃食管、胰腺及肝胆肿瘤展示时间：2025年5月31日 上午9:00-12:00（美国中部时间）演讲者：沈琳教授，北京大学肿瘤医院摘要标题：一项经肝动脉化疗栓塞(TACE)联合信迪利单抗（抗 PD-1）、奥沙利铂和 S-1，以及曲妥珠单抗（HER-2 阳性）或阿帕替尼（HER-2 阴性）作为胃癌肝转移一线治疗的II期临床研究摘要编号：4050会议类型：壁报会议环节：胃肠道肿瘤-胃食管、胰腺及肝胆肿瘤展示时间：2025年5月31日 上午9:00-12:00（美国中部时间）演讲者：沙丹教授，山东省立医院*除摘要7007外，信迪利单抗部分均为基于研究者申请发起的临床研究（IIT）关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®）， 雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。声明：1.信达不推荐任何未获批的药品/适应症使用。2.雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®）和匹妥布替尼片（捷帕力®）由礼来公司研发.前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。