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.
中國香港、上海和美國新澤西州:2025年5月23日,星期五:和黃醫藥(中國)有限公司(簡稱「和黃醫藥」或「HUTCHMED」)(納斯達克/倫敦證交所:HCM;香港交易所:13)今日宣佈和黃醫藥自主研發的化合物賽沃替尼(savolitinib)、HMPL-306(ranosidenib)、呋喹替尼(fruquintinib)和索凡替尼(surufatinib)的數項研究的最新及更新後的數據將於2025年5月30日至6月3日在美國芝加哥召開的2025年美國臨床腫瘤學會(ASCO)年會上公佈。
SACHI中國III期研究的結果將以最新突破性口頭報告的形式公佈,該研究旨在評估賽沃替尼聯合奧希替尼(osimertinib)用於一線表皮生長因子受體(「EGFR」)抑制劑治療後疾病進展的EGFR突變陽性伴MET擴增的局部晚期或轉移性非小細胞肺癌患者。 SACHI 在預設的中期分析中已達到預設的主要終點無進展生存期(「PFS」)。 SACHI研究的數據支持了該口服療法的新藥上市申請,該申請已於中國獲受理並納入優先審評。
賽沃替尼聯合奧希替尼用於治療既往接受奧希替尼治療後疾病進展、伴有MET過表達和/或擴增的EGFR突變的非小細胞肺癌患者的SAVANNAH II期研究中高MET過表達和/或擴增亞組的進一步數據,以及根據腦轉移狀態分層的分析結果亦於大會公佈。與賽沃替尼加安慰劑相比,賽沃替尼和奧希替尼的聯合療法顯示出更佳的療效。此聯合療法顯示出良好的中樞神經系統活性,延緩中樞神經系統進展並減少新的中樞神經系統病灶。
HMPL-306的I期臨床試驗劑量遞增階段的結果將於大會公佈。HMPL-306是一種新型、高選擇性的小分子口服異檸檬酸脫氫酶(「IDH」)1和IDH2酶雙重抑制劑,正於伴有IDH突變的局部晚期或轉移性實體瘤患者中開展研究。
結果顯示,該藥物耐受性良好,在患者中顯示出靶點抑制和持久的緩解。研究觀察到療效信號,且在低級別膠質瘤的療效評估組(N=14)中尤其顯著,客觀緩解率(「ORR」)為 7.1%,疾病控制率 (「DCR」)為 100%。
FRUSICA-1 開放標籤、單臂、關鍵性II期臨床試驗的亞組分析結果亦將公佈,該研究旨在評估呋喹替尼聯合信迪利單抗用於治療經治的晚期錯配修復完整(pMMR)子宮內膜癌患者的療效和安全性。漿液性癌患者(N=27)中觀察到具有臨床意義的療效結果,與整體研究人群(N=98)中觀察到的緩解情況相似。獨立審查委員會(「IRC」)評估的ORR為37.0%,DCR為88.9%。在緩解是否會受到既往新輔助/輔助化療(「NACT/ACT」)影響的分析中表明,無論患者既往是否曾接受 NACT/ACT治療,均顯示出持久且具有臨床意義的緩解。接受過和未接受NACT/ACT治療的患者的結果相若,IRC 評估的ORR分別為34.0%和31.4%,DCR分別為85.1%和82.4%。
兩項來自呋喹替尼在中國2798名結直腸癌患者中開展的IV期研究的亞組分析結果將會公佈。在評估呋喹替尼單藥療法和聯合療法安全性的亞組分析中,呋喹替尼在兩組中均顯示出可控的安全性。3級以上治療期間不良事件(TEAE)在呋喹替尼單藥治療組中發生率為23.94%,與其他抗癌藥物聯合療法組則為26.06%。兩組中最常見的治療相關不良事件(TRAE)均為掌蹠紅腫感覺異常(PPES)和高血壓。聯合療法組的治療持續時間更長,這可能表明患者的治療結果有所改善。在按年齡分組的亞組分析中,評估了呋喹替尼在較年輕患者(年齡<50歲)和高齡患者(年齡≥75歲)中的安全性。兩個年齡組中的安全性相似,較年輕患者接受了更為密集的治療。呋喹替尼聯合療法的治療持續時間在兩個年齡組中也均優於單藥療法,這可能表明帶來更高的生存獲益。
報告詳情包括已公佈的摘要鏈接如下:
摘要標題 | 報告人/ 主要作者 | 報告詳情 | |
公司申辦的研究 | |||
賽沃替尼聯合奧希替尼對比化療用於治療EGFR TKI治療後疾病進展的EGFR突變伴MET擴增的晚期非小細胞肺癌:SACHI III期隨機研究的結果 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 |
陸舜,上海交通大學醫學院附屬胸科醫院上海肺癌中心,中國上海 | LBA8505 口頭報告 | Oral Abstract Session: Lung Cancer – Non-Small Cell Metastatic 2025年6月1日 (星期日) 北美中部夏令時上午9:48 |
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賽沃替尼聯合奧希替尼對比賽沃替尼聯合安慰劑的SAVANNAH II期研究中隨機亞組的療效和中樞神經系統結果 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 快速口頭報告 | Rapid Oral Session: Lung Cancer – Non-Small Cell Metastatic 2025年6月2日 (星期一) 北美中部夏令時上午8:06 |
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IDH1/IDH2突變抑制劑HMPL-306用於治療晚期 IDH突變的實體瘤(包括神經膠質瘤)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 快速口頭報告 | Rapid Oral Session: Central Nervous System Tumors 2025年5月31日 (星期六) 北美中部夏令時下午3:06 |
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FRUSICA-1研究中漿液性癌的亞組分析: 呋喹替尼聯合信迪利單抗用於治療晚期pMMR子宮內膜癌患者 Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status |
吳小華,復旦大學附屬腫瘤醫院,中國上海 | 5596 海報展示 | Poster Session: Gynecologic Cancer |
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既往新輔助/輔助化療 (NACT/ACT) 對呋喹替尼聯合信迪利單抗在晚期pMMR子宮內膜癌患者中治療結果的影響: FRUSICA-1研究的亞組分析 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 |
王靜,湖南省腫瘤醫院,中國長沙 | 5611 海報展示 | Poster Session: Gynecologic Cancer |
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真實世界臨床實踐中呋喹替尼治療年輕和高齡結直腸癌中國患者的安全性: 呋喹替尼IV期研究的年齡亞組分析 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,寧波市第二醫院,中國寧波 | e15512 線上發表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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真實世界臨床實踐中呋喹替尼單藥療法和聯合療法治療中國結直腸癌患者的安全性: IV期研究的亞組分析 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 |
王志強,中山大學腫瘤防治中心,中國廣州 | e15515 線上發表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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血管生成抑制劑和化療用於晚期胃腺癌或胃食管結合部腺癌患者的適當治療順序: 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 |
李進,同濟大學附屬東方醫院,中國上海 | e16011 線上發表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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FRUTIGA研究中呋喹替尼聯合紫杉醇對比紫杉醇用於治療胃食管結合部腺癌的療效和安全性亞組分析: 一項二線治療胃/胃食管結合部腺癌的隨機III期臨床試驗 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 |
劉天舒,復旦大學附屬中山醫院,中國上海 | e16012 線上發表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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研究者發起的研究 | |||
呋喹替尼聯合卡瑞利珠單抗和紫杉醇脂質體和奈達鉑用於一線治療晚期食道鱗狀細胞癌: 一項單臂 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 |
顧艷宏,江蘇省人民醫院(南京醫科大學第一附屬醫院),中國南京 | 4042 海報展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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呋喹替尼聯合PD-1抑制劑及化療用於一線治療HER2陰性的晚期胃癌或胃食管結合部腺癌 (FDZL-FIX) 的更新結果: 一項單臂、開放標籤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,復旦大學附屬腫瘤醫院,中國上海 | 4046 海報展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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呋喹替尼聯合曲妥珠單抗及XELOX方案用於一線治療晚期HER2陽性的轉移性胃腺癌或胃食管結合部腺癌的開放標籤、單臂、單中心Ib/II期臨床試驗 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 |
呂慧芳,河南省腫瘤醫院(鄭州大學附屬腫瘤醫院),中國鄭州 | TPS4203 海報展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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轉移性結直腸癌治療的多隊列真實世界研究: 整體療效分析以及既往是否使用貝伐珠單抗的亞組分析 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 |
呂汪霞,浙江省腫瘤醫院,中國杭州 | e15530 線上發表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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呋喹替尼聯合伊立替康和卡培他濱用於二線治療晚期結直腸癌的真實世界觀察性研究 Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer |
徐玲,中國醫科大學附屬第一醫院,中國沈陽 | e15539 線上發表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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呋喹替尼聯合FOLFIRI方案用於二線治療RAS突變的轉移性結直腸癌的初步結果: 一項前瞻性單中心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 |
賈茹,解放軍總醫院第五醫學中心,中國北京 | e15541 線上發表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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評估呋喹替尼對比瑞戈非尼和曲氟尿苷/替吡嘧啶用於治療晚期轉移性結直腸癌的療效: 匹配調整間接比較 Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison |
秦叔逵,中國藥科大學附屬南京天印山醫院,中國南京 | e15550 線上發表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
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呋喹替尼聯合信迪利單抗和SOX方案作為初始不可切除的胃/胃食管結合部腺癌的轉化治療: 單臂II期臨床試驗的更新療效和手術結果 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 |
馬飛,河南省腫瘤醫院(鄭州大學附屬腫瘤醫院),中國鄭州 | e16016 線上發表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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一項評估呋喹替尼聯合恩沃利單抗用於治療晚期或不可切除的局部晚期骨肉瘤和軟組織肉瘤患者的療效和安全性的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 |
周陳亮,上海交通大學附屬第六人民醫院,中國上海 | e23506 線上發表 | Publication Only: Sarcoma |
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索凡替尼聯合紫杉醇用於二線治療晚期胃癌的療效和安全性: II 期研究的最終結果 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,上海交通大學醫學院附屬仁濟醫院,中國上海 | 4028 海報展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼聯合KN046和化療用於一線治療晚期胰腺的療效和安全性:一項單臂 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 |
王文權,復旦大學附屬中山醫院,中國上海 | 4157 海報展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼、卡瑞利珠單抗、白蛋白結合型紫杉醇和替吉奥用於一線治療局部晚期或轉移性胰腺導管腺癌患者: 一項 Ib/II 期隨機研究 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 |
賈茹/戴廣海, 解放軍總醫院第五醫學中心,中國北京 | 4161 海報展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
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一項探索帕米帕利聯合索凡替尼作為新輔助療法用於治療晚期不可切除卵巢癌的前瞻性、單臂、II期臨床研究 (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) |
夏百榮,中國科學技術大學附屬第一醫院,中國合肥 | 5589 海報展示 | Poster Session: Gynecologic Cancer |
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索凡替尼單藥療法用於三線治療晚期肝細胞癌的療效及安全性: 一項單臂、開放標籤、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,武漢大學中南醫院,中國武漢 | e16209 線上發表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼聯合吉西他濱與順鉑和免疫檢查點抑制劑用於治療不可切除的局部晚期或轉移性膽管細胞癌 Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma |
鐘敬濤/石學濤,山東第一醫科大學附屬腫瘤醫院,中國濟南 | e16222 線上發表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼聯合信迪利單抗和 IBI310 用於治療高級別晚期神經內分泌腫瘤患者的多中心、單臂 II 期研究的最新結果 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) |
陸明/沈琳,北京大學腫瘤醫院,中國北京 | e16342 線上發表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
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索凡替尼聯合吉西他濱和白蛋白結合型紫杉醇作為可切除和臨界可切除胰腺癌新輔助治療的前瞻性、單臂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/郝繼輝,天津醫科大學腫瘤醫院,中國天津 | e16442 線上發表 | Publication Only: Gastrointestinal Cancer -Gastroesophageal, Pancreatic, and Hepatobiliary |
和黃醫藥(納斯達克/倫敦證交所:HCM;香港交易所:13)是一家處於商業化階段的創新型生物醫藥公司,致力於發現、全球開發和商業化治療癌症和免疫性疾病的靶向藥物和免疫療法。自成立以來,和黃醫藥致力於將自主發現的候選藥物帶向全球患者,首三個藥物現已在中國上市,其中首個藥物亦於美國、歐洲和日本等全球各地獲批。欲了解更多詳情,請訪問:www.hutch‑med.com或關注我們的LinkedIn專頁。
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日期:星期四,2025年6月5日 |
時間:美國東部時間下午12時50分 (4:50pm GMT / 6月6日12:50am HKT) |