Hong Kong, Shanghai & Florham Park, NJ — Friday, May 30, 2025: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) hereby notifies the market that as at May 30, 2025, the issued share capital of HUTCHMED consisted of 871,611,095 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 871,611,095 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED shares under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.
For illustrative purposes only, the 871,611,095 ordinary shares would be equivalent to 871,611,095 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 174,322,219 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.
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.
中国香港、上海和美国新泽西州:2025年5月23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赛沃替尼(savolitinib)、HMPL-306(ranosidenib)、呋喹替尼(fruquintinib)和索凡替尼(surufatinib)的数项研究的最新及更新后的数据将于2025年5月30日至6月3日在美国芝加哥召开的2025年美国临床肿瘤学会(ASCO)年会上公布。
SACHI中国III期研究的结果将以最新突破性口头报告的形式公布,该研究旨在评估赛沃替尼联合奥希替尼(osimertinib)用于一线表皮生长因子受体(“EGFR”)抑制剂治疗后疾病进展的EGFR突变阳性伴MET扩增的局部晚期或转移性非小细胞肺癌患者。 SACHI 在预设的中期分析中已达到预设的主要终点无进展生存期(“PFS”)。 SACHI研究的数据支持了该口服疗法的新药上市申请,该申请已于中国获受理并纳入优先审评。
赛沃替尼联合奥希替尼用于治疗既往接受奥希替尼治疗后疾病进展、伴有MET过表达和/或扩增的EGFR突变的非小细胞肺癌患者的SAVANNAH II期研究中高MET过表达和/或扩增亚组的进一步数据,以及根据脑转移状态分层的分析结果亦于大会公布。与赛沃替尼加安慰剂相比,赛沃替尼和奥希替尼的联合疗法显示出更佳的疗效。此联合疗法显示出良好的中枢神经系统活性,延缓中枢神经系统进展并减少新的中枢神经系统病灶。
HMPL-306的I期临床试验剂量递增阶段的结果将于大会公布。HMPL-306是一种新型、高选择性的小分子口服异柠檬酸脱氢酶(“IDH”)1和IDH2酶双重抑制剂,正于伴有IDH突变的局部晚期或转移性实体瘤患者中开展研究。
结果显示,该药物耐受性良好,在患者中显示出靶点抑制和持久的缓解。研究观察到疗效信号,且在低级别胶质瘤的疗效评估组(N=14)中尤其显著,客观缓解率(“ORR”)为 7.1%,疾病控制率 (“DCR”)为 100%。
FRUSICA-1 开放标签、单臂、关键性II期临床试验的亚组分析结果亦将公布,该研究旨在评估呋喹替尼联合信迪利单抗用于治疗经治的晚期错配修复完整(pMMR)子宫内膜癌患者的疗效和安全性。浆液性癌患者(N=27)中观察到具有临床意义的疗效结果,与整体研究人群(N=98)中观察到的缓解情况相似。独立审查委员会(“IRC”)评估的ORR为37.0%,DCR为88.9%。在缓解是否会受到既往新辅助/辅助化疗(“NACT/ACT”)影响的分析中表明,无论患者既往是否曾接受 NACT/ACT治疗,均显示出持久且具有临床意义的缓解。接受过和未接受NACT/ACT治疗的患者的结果相若,IRC 评估的ORR分别为34.0%和31.4%,DCR分别为85.1%和82.4%。
两项来自呋喹替尼在中国2798名结直肠癌患者中开展的IV期研究的亚组分析结果将会公布。在评估呋喹替尼单药疗法和联合疗法安全性的亚组分析中,呋喹替尼在两组中均显示出可控的安全性。3级以上治疗期间不良事件(TEAE)在呋喹替尼单药治疗组中发生率为23.94%,与其他抗癌药物联合疗法组则为26.06%。两组中最常见的治疗相关不良事件(TRAE)均为掌跖红肿感觉异常(PPES)和高血压。联合疗法组的治疗持续时间更长,这可能表明患者的治疗结果有所改善。在按年龄分组的亚组分析中,评估了呋喹替尼在较年轻患者(年龄<50岁)和高龄患者(年龄≥75岁)中的安全性。两个年龄组中的安全性相似,较年轻患者接受了更为密集的治疗。呋喹替尼联合疗法的治疗持续时间在两个年龄组中也均优于单药疗法,这可能表明带来更高的生存获益。
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 | |||
赛沃替尼联合奥希替尼对比化疗用于治疗EGFR TKI治疗后疾病进展的EGFR突变伴MET扩增的晚期非小细胞肺癌:SACHI III期随机研究的结果 Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study |
陆舜,上海交通大学医学院附属胸科医院上海肺癌中心,中国上海 | LBA8505 口头报告 | Oral Abstract Session: Lung Cancer – Non-Small Cell Metastatic 2025年6月1日 (星期日) 北美中部夏令时上午9:48 |
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赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的SAVANNAH II期研究中随机亚组的疗效和中枢神经系统结果 Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) |
Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD | 8513 快速口头报告 | Rapid Oral Session: Lung Cancer – Non-Small Cell Metastatic 2025年6月2日 (星期一) 北美中部夏令时上午8:06 |
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IDH1/IDH2突变抑制剂HMPL-306用于治疗晚期 IDH突变的实体瘤(包括神经胶质瘤)西方患者的 I 期研究 Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma |
Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX | 2013 快速口头报告 | Rapid Oral Session: Central Nervous System Tumors 2025年5月31日 (星期六) 北美中部夏令时下午3:06 |
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FRUSICA-1研究中浆液性癌的亚组分析: 呋喹替尼联合信迪利单抗用于治疗晚期pMMR子宫内膜癌患者 Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status |
吴小华,复旦大学附属肿瘤医院,中国上海 | 5596 海报展示 | Poster Session: Gynecologic Cancer |
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既往新辅助/辅助化疗 (NACT/ACT) 对呋喹替尼联合信迪利单抗在晚期pMMR子宫内膜癌患者中治疗结果的影响: FRUSICA-1研究的亚组分析 The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 |
王静,湖南省肿瘤医院,中国长沙 | 5611 海报展示 | Poster Session: Gynecologic Cancer |
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真实世界临床实践中呋喹替尼治疗年轻和高龄结直肠癌中国患者的安全性: 呋喹替尼IV期研究的年龄亚组分析 Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study |
王奕,宁波市第二医院,中国宁波 | e15512 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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真实世界临床实践中呋喹替尼单药疗法和联合疗法治疗中国结直肠癌患者的安全性: IV期研究的亚组分析 Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study |
王志强,中山大学肿瘤防治中心,中国广州 | e15515 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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血管生成抑制剂和化疗用于晚期胃腺癌或胃食管结合部腺癌患者的适当治疗顺序: FRUTIGA III期研究的探索性分析 The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study |
李进,同济大学附属东方医院,中国上海 | e16011 线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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FRUTIGA研究中呋喹替尼联合紫杉醇对比紫杉醇用于治疗胃食管结合部腺癌的疗效和安全性亚组分析: 一项二线治疗胃/胃食管结合部腺癌的随机III期临床试验 Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction |
刘天舒,复旦大学附属中山医院,中国上海 | e16012 线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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研究者发起的研究 | |||
呋喹替尼联合卡瑞利珠单抗和紫杉醇脂质体和奈达铂用于一线治疗晚期食道鳞状细胞癌: 一项单臂 II 期研究 Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study |
顾艳宏,江苏省人民医院(南京医科大学第一附属医院),中国南京 | 4042 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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呋喹替尼联合PD-1抑制剂及化疗用于一线治疗HER2阴性的晚期胃癌或胃食管结合部腺癌 (FDZL-FIX) 的更新结果: 一项单臂、开放标签II期研究 Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study |
王辰辰,复旦大学附属肿瘤医院,中国上海 | 4046 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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呋喹替尼联合曲妥珠单抗及XELOX方案用于一线治疗晚期HER2阳性的转移性胃腺癌或胃食管结合部腺癌的开放标签、单臂、单中心Ib/II期临床试验 Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma |
吕慧芳,河南省肿瘤医院(郑州大学附属肿瘤医院),中国郑州 | TPS4203 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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转移性结直肠癌治疗的多队列真实世界研究: 整体疗效分析以及既往是否使用贝伐珠单抗的亚组分析 A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not |
吕汪霞,浙江省肿瘤医院,中国杭州 | e15530 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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呋喹替尼联合伊立替康和卡培他滨用于二线治疗晚期结直肠癌的真实世界观察性研究 Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer |
徐玲,中国医科大学附属第一医院,中国沈阳 | e15539 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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呋喹替尼联合FOLFIRI方案用于二线治疗RAS突变的转移性结直肠癌的初步结果: 一项前瞻性单中心II期研究 Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study |
贾茹,解放军总医院第五医学中心,中国北京 | e15541 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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评估呋喹替尼对比瑞戈非尼和曲氟尿苷/替吡嘧啶用于治疗晚期转移性结直肠癌的疗效: 匹配调整间接比较 Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison |
秦叔逵,中国药科大学附属南京天印山医院,中国南京 | e15550 线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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呋喹替尼联合信迪利单抗和SOX方案作为初始不可切除的胃/胃食管结合部腺癌的转化治疗: 单臂II期临床试验的更新疗效和手术结果 Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial |
马飞,河南省肿瘤医院(郑州大学附属肿瘤医院),中国郑州 | e16016 线上发表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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一项评估呋喹替尼联合恩沃利单抗用于治疗晚期或不可切除的局部晚期骨肉瘤和软组织肉瘤患者的疗效和安全性的II期研究 A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma |
周陈亮,上海交通大学附属第六人民医院,中国上海 | e23506 线上发表 | Publication Only: Sarcoma |
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索凡替尼联合紫杉醇用于二线治疗晚期胃癌的疗效和安全性: II 期研究的最终结果 Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial |
肖秀英,上海交通大学医学院附属仁济医院,中国上海 | 4028 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼联合KN046和化疗用于一线治疗晚期胰腺的疗效和安全性:一项单臂 Ib/II 期研究 Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial |
王文权,复旦大学附属中山医院,中国上海 | 4157 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼、卡瑞利珠单抗、白蛋白结合型紫杉醇和替吉奥用于一线治疗局部晚期或转移性胰腺导管腺癌患者: 一项 Ib/II 期随机研究 First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study |
贾茹/戴广海, 解放军总医院第五医学中心,中国北京 | 4161 海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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一项探索帕米帕利联合索凡替尼作为新辅助疗法用于治疗晚期不可切除卵巢癌的前瞻性、单臂、II期临床研究 (PASSION) A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) |
夏百荣,中国科学技术大学附属第一医院,中国合肥 | 5589 海报展示 | Poster Session: Gynecologic Cancer |
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索凡替尼单药疗法用于三线治疗晚期肝细胞癌的疗效及安全性: 一项单臂、开放标签、多中心II期研究 The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study |
周福祥,武汉大学中南医院,中国武汉 | e16209 线上发表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼联合吉西他滨与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胆管细胞癌 Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma |
钟敬涛/石学涛,山东第一医科大学附属肿瘤医院,中国济南 | e16222 线上发表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼联合信迪利单抗和 IBI310 用于治疗高级别晚期神经内分泌肿瘤患者的多中心、单臂 II 期研究的最新结果 Updated results from a multicenter, single-arm Phase ll study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) |
陆明/沈琳,北京大学肿瘤医院,中国北京 | e16342 线上发表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼联合吉西他滨和白蛋白结合型紫杉醇作为可切除和临界可切除胰腺癌新辅助治疗的前瞻性、单臂II 期研究 A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer |
高松/郝继辉,天津医科大学肿瘤医院,中国天津 | e16442 线上发表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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。
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日期:星期四,2025年6月5日 |
时间:美国东部时间下午12时50分 (4:50pm GMT / 6月6日12:50am HKT) |