中国香港、上海和美国新泽西州:2026年5月22日,星期五:和黄医药(中国)有限公司(简称“和黄医药”或“HUTCHMED”)(纳斯达克/伦敦证交所:HCM;香港交易所:13)今日宣布和黄医药自主研发的化合物的数项研究的最新及更新后的数据将于2026年5月29日至6月2日在美国芝加哥召开的美国临床肿瘤学会(ASCO)年会上公布。
赛沃替尼(savolitinib)用于治疗伴有MET扩增的胃癌或胃食道连接部腺癌患者的中国关键性II期注册研究结果将于快速口头摘要环节公布。该研究已达到主要终点,即根据RECIST 1.1标准经独立审查委员会(“IRC”)评估的客观缓解率(“ORR”)。至数据截止日2025年10月8日,IRC评估的ORR为32.3%(95%CI:21.2%,45.1%),超过了预设的疗效阈值。次要终点包括IRC评估的疾病控制率(DCR)为63.1%,中位到达疾病缓解的时间(TTR)为1.4个月,中位缓解持续时间(DoR)为9.7个月(95%CI:3.7,18.5),以及中位无进展生存期(PFS)为4.0个月(95%CI:2.6,5.0)。这些数据支持了向中国国家药品监督管理局提交新药上市申请,该申请已于2025年12月获受理并纳入优先审评。
此外,呋喹替尼(fruquintinib)的FRESCO、FRESCO-2、FRUSICA-1和FRUSICA-2研究的进一步分析结果,以及由研究者发起的呋喹替尼和索凡替尼(surufatinib)在多项潜在肿瘤适应症中的临床试验结果亦将于大会公布。
报告详情包括已公布的摘要链接如下:
| 摘要标题 | 报告人/ 主要作者 | 报告详情 |
公司申办的研究 |
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| 赛沃替尼用于治疗伴有MET扩增的胃癌或胃食道连接部腺癌患者的一项II期关键性研究 A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas |
彭智,中国北京 | 4011 快速口头摘要 | Rapid Oral Abstract: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary 2026年6月1日 (星期一) 北美中部夏令时间下午1:15 |
| 呋喹替尼治疗转移性结直肠癌患者的肿瘤缩小和缓解深度: FRESCO和FRESCO-2研究结果 Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2 |
Elena Elez,西班牙巴塞罗那 | 3555 海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal |
| 呋喹替尼联合信迪利单抗对比阿昔替尼或依维莫司在经治的晚期肾细胞癌患者中基于基线IMDC风险评分和PD-L1表达情况评估的疗效: FRUSICA-2研究的亚组分析 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 |
杨恺惟,中国北京 | 4531 海报展示 | Poster Session: Genitourinary Cancer – Kidney and Bladder |
| 呋喹替尼联合信迪利单抗对比阿昔替尼或依维莫司在晚期肾细胞癌中的疗效: 一项基于基线肿瘤负荷的FRUSICA-2研究事后分析 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 |
瞿元元,中国上海 | 4533 海报展示 | Poster Session: Genitourinary Cancer – Kidney and Bladder |
| 经治的pMMR子宫内膜癌患者中掌跖红肿综合征、甲状腺功能减退与临床结局的相关性: FRUSICA-1研究的亚组分析 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 |
韩啸天,中国上海 | e17612 线上发表 | Publication Only: Gynecologic Cancer |
研究者发起的研究 |
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| 呋喹替尼联合化疗和贝伐珠单抗联合化疗用于二线治疗转移性结直肠癌的疗效和安全性: 一项前瞻性、多中心、随机对照研究 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 |
许剑民,中国上海 | LBA3563 海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal |
| CONCEPT研究 (西妥昔单抗联合呋喹替尼±免疫疗法): 一项一线治疗pMMR RAS/ BRAF野生型不可切除的转移性结直肠癌的多中心、随机、开放标签的II期研究 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 |
刘月,中国杭州 | TPS3680 海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal |
| 呋喹替尼联合替雷利珠单抗对比曲氟尿苷/替吡嘧啶联合贝伐珠单抗用于治疗无活动性肝转移的MSS转移性结直肠癌患者的疗效: IKF-080/QUINTIS研究 Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF‑080/QUINTIS trial |
Joseph Tintelnot,德国汉堡 | TPS3684 海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal |
| 一项评估呋喹替尼联合信迪利单抗和西达本胺用于治疗难治性MSS转移性结直肠癌的II期研究: 初步疗效和安全性 A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety |
王畅,中国长春 | 2631 海报展示 | Poster Session: Developmental Therapeutics – Immunotherapy |
| 呋喹替尼联合FOLFIRI或mFOLFOX6方案用于二线治疗RAS突变转移性结直肠癌患者: 一项II期、多中心、开放标签研究 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 |
许贇,中国上海 | 3528 海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal |
| 呋喹替尼联合卡培他滨对比卡培他滨单药作为转移性结直肠癌一线化疗后维持治疗的一项II期随机研究 A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC) |
李文桦,中国上海 | 3534 海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal |
| 呋喹替尼联合卡度尼利单抗用于治疗伴有肺转移的难治性MSS/pMMR结直肠癌的一项II期临床试验 A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases |
郭梦舟,中国上海 | 3552 海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal |
| 免疫化疗联合或不联合呋喹替尼用于一线治疗晚期胃癌/胃食道连接部腺癌的基于生物标志物的评估: MGC-FLORA研究的初步临床结果和亚组分析 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 |
朱晓东,中国上海 | 4063 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
| 优替德隆联合呋喹替尼治疗铂耐药复发性卵巢癌的II期临床试验 (FRUTD研究) Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) |
温灏,中国上海 | 5579 海报展示 | Poster Session: Gynecologic Cancer |
| 呋喹替尼和贝伐珠单抗联合卡培他滨交替作为转移性结直肠癌一线治疗后的维持治疗: 一项多中心、开放标签的II期研究 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 |
廖旺军,中国广州 | e15539 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
| 间歇应用呋喹替尼联合曲氟尿苷/替吡嘧啶治疗难治性转移性结直肠癌: 一项单中心、单臂II期研究 Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study |
何义富/牛佳郁,中国合肥 | e15560 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
| 伊立替康脂质体联合呋喹替尼作为转移性结直肠癌三线或后线治疗的I期研究 Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer |
黎倩,中国南宁 | e15571 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
| 西达本胺联合斯鲁利单抗和瑞戈非尼或呋喹替尼用于三线治疗晚期结直肠癌 (C‑operate/SCOG‑C001研究): 一项单臂、探索性、多中心II期临床试验 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 |
李伟,中国苏州 | e15583 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
| 呋喹替尼在美国难治性转移性结直肠癌的真实世界应用 Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States |
Vasu Bansal,美国堪萨斯城 | e15713 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
| 呋喹替尼联合信迪利单抗和CAPEOX用于一线治疗晚期胃癌/胃食道连接部腺癌: 一项单臂、开放标签、多中心Ib/II期临床试验 (FUNCTION研究) 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) |
陈贝贝,中国郑州 | e16033 线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
| 呋喹替尼联合卡瑞利珠单抗、紫杉醇脂质体和奈达铂用于一线治疗晚期食管鳞状细胞癌: 一项单臂II期研究的最新结果 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 |
顾艳宏,中国南京 | e16070 线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
| 索凡替尼联合吉西他滨、顺铂和免疫检查点抑制剂用于治疗不可切除的局部晚期或转移性肝内胆管癌的最新结果 Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma |
石学涛/钟敬涛,中国济南 | 4136 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
| 索凡替尼联合KN046和化疗用于一线治疗晚期胰腺导管腺癌: 一项Ib/II期研究的最新结果和生物标志物分析 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 |
王文权,中国上海 | 4198 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
| 索凡替尼联合特瑞普利单抗用于治疗复发性卵巢透明细胞癌: 一项前瞻性单中心、单臂II期临床试验的最新进展 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 |
杨慧娟,中国上海 | 5586 海报展示 | Poster Session: Gynecologic Cancer |
| 索凡替尼治疗晚期或转移性化疗难治性胸腺上皮肿瘤: 一项单臂、单中心II期研究 Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study |
徐蓓,中国上海 | 8119 海报展示 | Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers |
| 索凡替尼联合抗PD-1/PD-L1抗体用于二线治疗或单药用于三线治疗晚期肝细胞癌:一项单臂、开放标签、多中心II期研究 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 |
周福祥,中国武汉 | e16172 线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
| 索凡替尼联合免疫检查点抑制剂和化疗用于治疗胆管癌患者的疗效和安全性: 一项真实世界研究 Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study |
范莎莎,中国长沙 | e16222 线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
| 奥希替尼联合赛沃替尼用于治疗低MET基因拷贝数的奥希替尼耐药性非小细胞肺癌: 一项多中心、开放标签的II期研究 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 |
韩翔,中国青岛 | e20079 线上发表 | Publication Only: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers |
和黄医药(纳斯达克/伦敦证交所:HCM;香港交易所:13)是一家处于商业化阶段的创新型生物医药公司,致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来,和黄医药致力于将自主发现的候选药物带向全球患者,首三个药物现已在中国上市,其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情,请访问:www.hutch‑med.com或关注我们的领英专页。
前瞻性陈述
本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期,包括对呋喹替尼、赛沃替尼和索凡替尼的治疗潜力的预期,呋喹替尼、赛沃替尼和索凡替尼的进一步临床研究计划,对呋喹替尼、赛沃替尼和索凡替尼的研究是否能达到其主要或次要终点的预期,以及对此类研究完成时间和结果发布的预期。此类风险和不确定性包括下列假设:入组率、满足研究入选和排除标准的受试者的时间和可用性;临床方案或监管要求变更;非预期不良事件或安全性问题;呋喹替尼、赛沃替尼和索凡替尼(包括作为联合疗法)达到研究的主要或次要终点的疗效;获得不同司法管辖区的监管批准及获得监管批准后获得上市许可;呋喹替尼、赛沃替尼和索凡替尼用于目标适应症的潜在市场,以及资金充足性等。此外,由于部分研究可能依赖于与其他药物联合使用,因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述,这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论,请查阅和黄医药向美国证券交易委员会、香港联合交易所有限公司以及AIM提交的文件。无论是否出现新讯息、未来事件或情况或其他因素,和黄医药均不承担更新或修订本新闻稿所含讯息的义务。
医疗信息
本新闻稿所提到的产品可能并未在所有国家上市,或可能以不同的商标进行销售,或用于不同的病症,或采用不同的剂量,或拥有不同的效力。本文中所包含的任何信息都不应被看作是任何处方药的申请、推广或广告,包括那些正在研发的药物。