HUTCHMED (Nasdaq: HCM) showcases savolitinib, fruquintinib and surufatinib data at ASCO 2026
Rhea-AI Filing Summary
HUTCHMED (China) Limited is sharing a broad set of oncology clinical data at the 2026 ASCO Annual Meeting in Chicago. The centerpiece is a pivotal Phase II registration study of savolitinib in MET-amplified gastric or gastroesophageal junction cancer in China.
The savolitinib study met its primary endpoint, with an Independent Review Committee–assessed objective response rate of 32.3% as of October 8, 2025, exceeding a pre-specified efficacy threshold. Disease control rate was 63.1%, median time to response 1.4 months, duration of response 9.7 months, and progression-free survival 4.0 months. These data supported a New Drug Application in China that was accepted and granted priority review.
The company will also present further analyses from its fruquintinib FRESCO, FRESCO-2, FRUSICA-1 and FRUSICA-2 studies, plus numerous investigator-initiated studies of fruquintinib and surufatinib across colorectal, gastric, renal, gynecologic, hepatobiliary, pancreatic, lung and other tumor types, highlighting the breadth of its clinical development program.
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Insights
HUTCHMED reports pivotal savolitinib Phase II success and broad ASCO presence, advancing its oncology pipeline but without final approvals yet.
HUTCHMED is showcasing multiple programs at the 2026 ASCO Meeting, led by a pivotal Phase II registration study of savolitinib in MET-amplified gastric and gastroesophageal junction cancer. The trial met its primary endpoint, with an Independent Review Committee objective response rate of 32.3%, above a predefined efficacy threshold.
Secondary outcomes include disease control rate of 63.1%, median time to response of 1.4 months, duration of response of 9.7 months, and progression-free survival of 4.0 months as of the October 8, 2025 data cut-off. These data supported a New Drug Application in China that received priority review, indicating regulators view the submission as time-sensitive.
Alongside savolitinib, HUTCHMED is presenting extensive analyses of fruquintinib (FRESCO, FRESCO-2, FRUSICA-1, FRUSICA-2) and numerous investigator-initiated studies with fruquintinib and surufatinib across colorectal, gastric, renal, gynecologic, hepatobiliary, pancreatic, lung and other indications. Future disclosures in company filings may provide updated regulatory decisions and later-phase development plans building on these data.
Key Figures
Key Terms
objective response rate medical
disease control rate medical
progression-free survival medical
Phase II registration study medical
priority review regulatory
investigator-initiated studies medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the Month of May 2026
Commission File Number: 001-37710
HUTCHMED (CHINA) LIMITED
(Translation of registrant’s name into English)
48th Floor, Cheung Kong Center, 2 Queen’s Road Central, Hong Kong
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ⌧ Form 40-F ◻
HUTCHMED (CHINA) LIMITED
Form 6-K
EXHIBIT INDEX
Exhibit No. | | Description |
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Exhibit 99.1 | | Press release relating to clinical data to be presented at the 2026 ASCO Annual Meeting |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| HUTCHMED (CHINA) LIMITED | |
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| By: | /s/ Johnny Cheng |
| Name: | Johnny Cheng |
| Title: | Chief Financial Officer |
Date: May 22, 2026
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Exhibit 99.1
Press Release
HUTCHMED Highlights Clinical Data to be Presented at the 2026 ASCO Annual Meeting
Hong Kong, Shanghai & Florham Park, NJ — Friday, May 22, 2026: 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 |
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 |
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 |
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 |
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 |
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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 |
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 |
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 |
Abstract title | Presenter / Lead Author | Presentation details |
|---|---|---|
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 |
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 |
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 |
A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases | Mengzhou Guo, Shanghai, China | 3552 |
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 |
Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) | Hao Wen, Shanghai, China | 5579 |
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 |
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 |
Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer | Qian Li, Nanning, China | e15571 |
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 |
Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States | Vasu Bansal, Kansas City, US | e15713 |
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 |
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 |
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 |
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 |
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 |
Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study | Bei Xu, Shanghai, China | 8119 |
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 |
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 |
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 |
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 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 |