STOCK TITAN

HUTCHMED combo cuts death risk 32% versus chemotherapy

HUTCHMED said the U.S. SAFFRON application has been submitted; its SANOVO China supplemental application is planned.

(Moderate)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
6-K

Rhea-AI Filing Summary

HUTCHMED (China) Limited reported Phase III results for ORPATHYS® plus TAGRISSO® in SAFFRON and SANOVO, trials of EGFR-mutated non-small cell lung cancer in different MET-related settings. In SAFFRON, after progression on TAGRISSO®, the combination versus platinum-based chemotherapy reduced the risk of progression or death by 45% (median PFS 7.6 vs. 5.4 months) and the risk of death by 32% (median OS 17.8 vs. 12.9 months).

In first-line SANOVO, versus TAGRISSO® alone, the combination reduced progression-or-death risk by 44% in the intention-to-treat population; median PFS was 24.9 vs. 13.8 months and median OS was 44.5 vs. 34.9 months. In the high-MET population, median PFS was 24.8 vs. 11.1 months. HUTCHMED said the U.S. NDA for the SAFFRON setting was submitted and a China supplemental NDA for SANOVO is planned. In SAFFRON, grade 3 or higher treatment-emergent adverse events occurred in 64% versus 63% of patients, with no new safety concerns reported.

2 points · 2 major

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 0 points

How the balance works

Positive

  • Major pointSAFFRON death risk decreased 32% versus chemotherapy.
  • Major pointSANOVO ITT progression-or-death risk decreased 44% versus TAGRISSO® alone.

Negative

  • None.
Reduction in risk of progression or death 45% SAFFRON; combination versus doublet platinum-based chemotherapy
Median PFS 7.6 months vs. 5.4 months SAFFRON; combination versus doublet platinum-based chemotherapy
Reduction in risk of death 32% SAFFRON; combination versus chemotherapy
Median OS 17.8 months vs. 12.9 months SAFFRON; combination versus chemotherapy
Reduction in risk of progression or death 44% SANOVO intention-to-treat population; combination versus TAGRISSO® alone
Median PFS 24.9 months vs. 13.8 months SANOVO intention-to-treat population
Median PFS 24.8 months vs. 11.1 months SANOVO high-MET population
Median OS 44.5 months vs. 34.9 months SANOVO intention-to-treat population
progression-free survival medical
"improvement in both progression-free survival (“PFS”)"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
overall survival medical
"and overall survival (“OS”)"
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
hazard ratio medical
"PFS hazard ratio [“HR”] of 0.55"
A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.
intention-to-treat medical
"intention-to-treat (“ITT”) trial populations"
A method for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed the protocol. Like judging a sports team's season based on the original roster rather than only the players who actually played every game, it gives a conservative, real-world estimate of how a treatment performs and helps investors judge the likelihood regulators and markets will value the therapy.
blinded independent central review medical
"assessed by blinded independent central review (“BICR”)"
Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did HUTCHMED’s SANOVO trial show?

In SANOVO’s intention-to-treat population, ORPATHYS® plus TAGRISSO® reduced progression-or-death risk by 44% versus TAGRISSO® alone. Median PFS was 24.9 versus 13.8 months, and median OS was 44.5 versus 34.9 months. In the high-MET population, median PFS was 24.8 versus 11.1 months.

What regulatory applications has HUTCHMED submitted or planned for ORPATHYS® plus TAGRISSO®?

The U.S. NDA for the SAFFRON setting was submitted to the FDA for patients with locally advanced or metastatic NSCLC with high MET overexpression or amplification after progression on or after EGFR-TKI therapy. European and Japanese submissions were progressing as planned, and HUTCHMED plans a supplemental China NDA for SANOVO’s first-line setting.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR Accepted by SEC EDGAR Learn about SEC filing dates

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 6-K

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REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

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For the Month of October 2026

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Commission File Number: 001-37710

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HUTCHMED (CHINA) LIMITED

(Translation of registrant’s name into English)

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48th Floor, Cheung Kong Center, 2 Queen’s Road Central, Hong Kong

(Address of principal executive offices)

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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

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Form 20-F  ⌧             Form 40-F  ◻

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HUTCHMED (CHINA) LIMITED

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Form 6-K

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EXHIBIT INDEX

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Exhibit No.

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Description

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Exhibit 99.1

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Press release relating to HUTCHMED highlights SAFFRON global phase III data presented at ESMO Congress 2026 and simultaneously published in The New England Journal of Medicine

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Exhibit 99.2

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Press release relating to HUTCHMED highlights SANOVO phase III data for ORPATHYS® plus TAGRISSO® in first-line EGFR-mutated lung cancer presented at ESMO Congress 2026

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SIGNATURE

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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.

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HUTCHMED (CHINA) LIMITED

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By:

/s/ Johnny Cheng

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Name:

Johnny Cheng

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Title:

Chief Financial Officer

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Date: October 26, 2026

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Exhibit 99.1

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Graphic

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Press Release

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HUTCHMED Highlights SAFFRON Global Phase III Data Presented at ESMO Congress 2026 and Simultaneously Published in The New England Journal of Medicine

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— ORPATHYS® plus TAGRISSO® reduced the risk of disease progression or death by 45% and the risk of death by 32% in MET-driven EGFR-mutated lung cancer after progression on TAGRISSO® —

— ORPATHYS® plus TAGRISSO® extended median OS by nearly 5 months —

— SAFFRON is the first global Phase III trial to show significant progression-free and overall survival benefit in this setting —

— Establishes ORPATHYS® plus TAGRISSO® as an important targeted strategy to address MET-driven resistance following progression on prior EGFR TKI treatment —

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Hong Kong, Shanghai & Florham Park, NJ — Monday, October 26, 2026: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces positive results from the SAFFRON global Phase III trial. ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (“PFS”) and overall survival (“OS”) versus doublet platinum-based chemotherapy in patients with epidermal growth factor receptor-mutated (“EGFRm”) non-small cell lung cancer (“NSCLC”). Patients in the trial had tumors with high levels of MET overexpression or amplification and had progressed on prior treatment with TAGRISSO®.

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These results have been presented during the Presidential Symposium at the European Society for Medical Oncology (“ESMO”) Congress in Madrid, Spain (abstract #LBA6). 1 They were also simultaneously published in The New England Journal of Medicine 2026. Featuring prominently on oncology’s premier stage and in a flagship journal underscores the pivotal nature of the SAFFRON trial in redefining the treatment paradigms for MET-driven EGFRm NSCLC. The data validate ORPATHYS® combined with TAGRISSO® as a landmark, all-oral strategy to address the major unmet need of MET-driven resistance after third-generation epidermal growth factor receptor (“EGFR”) tyrosine kinase inhibitor (“TKI”) therapy.

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Results showed ORPATHYS® plus TAGRISSO® reduced the risk of disease progression or death by 45% compared to chemotherapy (based on a PFS hazard ratio [“HR”] of 0.55; 95% confidence interval [“CI”] 0.42-0.72; p<0.001). Median PFS as assessed by blinded independent central review (“BICR”) was 7.6 months for ORPATHYS® plus TAGRISSO® versus 5.4 months for the comparator arm. An estimated 36% of patients treated with the combination were progression-free at one year compared to 10% in the comparator arm. Importantly, the PFS benefit observed was consistent across all prespecified subgroups, including patients whose tumor had MET-overexpression or MET-amplification.

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Results for the key secondary endpoint of OS showed ORPATHYS® plus TAGRISSO® reduced the risk of death by 32% versus chemotherapy (OS HR 0.68; 95% CI 0.50-0.91; p=0.010). ORPATHYS® plus TAGRISSO® extended median OS by 4.9 months versus the comparator arm (17.8 versus 12.9 months). An estimated 70% of patients treated with the combination were alive at one year compared to 53% in the comparator arm.

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Professor Shun Lu, Director of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, School of Medicine and global leading principal investigator of the trial, said: “These results have the potential to establish a new global standard of care for the third of patients with EGFR-mutated non-small cell lung cancer experiencing MET-driven resistance after osimertinib. There are currently no well-tolerated, oral, biomarker-directed treatment options to address this frequent driver of disease progression. Savolitinib plus osimertinib significantly extended median overall survival by nearly five months in this later-line setting, establishing a new clinical benchmark and reinforcing the critical need for MET testing to guide patient care.”


Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said: “These data from SAFFRON mark a decisive step forward in targeting MET-driven resistance — a longstanding challenge in EGFR-mutated lung cancer. Precision inhibition with ORPATHYS® alongside TAGRISSO® offers a meaningful, all-oral option for patients with disease progression. We are delighted to see that our partnership with AstraZeneca continues to deliver impactful innovations that have the potential to redefine standard of care and improve outcomes for patients globally.”

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Dr Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “These data show combining ORPATHYS® with backbone therapy TAGRISSO® directly addresses MET-driven resistance while maintaining EGFR suppression, building on the established efficacy, safety and central nervous system protection of TAGRISSO®. With the potential to become the first biomarker-directed, all-oral treatment option in this setting, this combination further strengthens our leadership in EGFR-mutated lung cancer and reflects our strategy of matching the right therapy to the underlying drivers of disease at every stage.”

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Summary of PFS and OS results: SAFFRON i

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ORPATHYS® + TAGRISSO®

(n=171)

Chemotherapy

(n=167)

PFS by BICR: Full Analysis Set (FAS)

Number of patients with event, n (%)

117 (68.4)

113 (67.7)

Median PFS (95% CI) (in months)

7.6 (5.6-9.7)

5.4 (4.2-5.8)

HR (95% CI)

0.55 (0.42-0.72)

p-value

p<0.001

PFS rate at 12 months (%)

36

10

OS: FAS 

Number of deaths, n (%)  

87 (50.9)  

93 (55.7)  

Median OS (95% CI) (in months)  

17.8 (15.6-23.7)  

12.9 (10.6-16.8)  

HR (95% CI)  

0.68 (0.50-0.91)  

p-value  

p=0.010  

OS rate at 12 months (%) 

70 

53 

PFS by BICR: MET-overexpressed analysis set

Number of patients, n

127

118

Number of patients with event, n (%)

77 (60.6)

80 (67.8)

Median PFS (95% CI) (in months)

8.5 (5.7-11.1)

5.6 (4.4-6.7)

HR (95% CI)

0.51 (0.37-0.71)

p-value

p<0.001

PFS rate at 12 months (%)

40

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PFS by BICR: MET-amplified analysis set ii

Number of patients, n

129

116

Number of patients with event, n (%)

89 (68.9)

79 (68.1)

Median PFS (95% CI) (in months)

7.64 (5.6-9.7)

4.2 (3.1-5.5)

HR (95% CI)

0.487 (0.35-0.66)

PFS rate at 12 months (%)

33

8

i  OS and PFS data cut-off was 6 July 2026. 

ii No formal statistical testing was carried out for the MET-amplified analysis set

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The safety profile for ORPATHYS® plus TAGRISSO® was manageable and consistent with the known profiles of each medicine, and there were no new safety concerns. Grade 3 or higher treatment-emergent adverse events from all causes occurred in 64% of patients treated with ORPATHYS® plus TAGRISSO® and 63% of patients in the comparator arm. Median total duration of


treatment exposure was more than twice as long for ORPATHYS® plus TAGRISSO® (8.5 months) compared with the comparator arm (3.5 months).

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Based on the SAFFRON Phase III trial results, a New Drug Application (“NDA”) for ORPATHYS® plus TAGRISSO® were submitted to the US Food and Drug Administration for the treatment of patients with locally advanced or metastatic NSCLC whose tumors have high levels of MET overexpression or amplification and who had disease progression on or after an EGFR-TKI therapy. An NDA submission in Europe and Japan is also progressing as planned. ORPATHYS® plus TAGRISSO® is approved in China for patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy based on the SACHI Phase III trial.

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Results from the SANOVO Phase III trial evaluating ORPATHYS® plus TAGRISSO® in treatment-naïve patients in China with EGFRm locally advanced or metastatic NSCLC and MET overexpression will be presented during a Proffered Paper session at the ESMO Congress (abstract #LBA69). 2

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ORPATHYS® is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.

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About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death globally, accounting for almost one in four (23%) cancer deaths.3, 4 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.5 Approximately 75% of NSCLC patients are diagnosed with advanced disease.6 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.​7

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MET is a tyrosine kinase receptor that has an essential role in normal cell development.8 MET overexpression or amplification can lead to tumor growth and the metastatic progression of cancer cells.8,9 Approximately one in three patients’ tumors will develop high levels of MET overexpression or amplification (IHC3+>90% and FISH10+) after progression on a third-generation EGFR-TKI.10

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About SAFFRON

SAFFRON is a randomized, open-label, multi-center, global Phase III trial studying the efficacy of ORPATHYS® (300 mg twice daily) added to TAGRISSO® (80 mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following first- or second-line treatment with TAGRISSO®. The trial enrolled patients in 230 centers across 29 countries in North America, Europe, South America and Asia. The primary endpoint is PFS and key secondary endpoint includes OS.

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Patients were prospectively selected for SAFFRON using the high MET level cut-offs identified in the SAVANNAH Phase II trial. ​In SAVANNAH, MET overexpression or amplification levels were determined by two tests: immunohistochemistry (IHC), which detects if cancer cells have a particular protein or marker on their surface, and fluorescence in situ hybridization (FISH), which detects a specific DNA sequence from cancer cells.

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About ORPATHYS®  

ORPATHYS® (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It 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.

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ORPATHYS® is approved in China 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. ORPATHYS® also received a conditional approval in China for the treatment of adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. ORPATHYS® in combination with TAGRISSO® is approved in China for patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy based on the SACHI Phase III trial. The combination was also granted a temporary authorization in Switzerland for the treatment of patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with TAGRISSO®. This was based on results from the global SAVANNAH Phase II trial. The global, randomized, SAFFRON Phase III trial in the same treatment setting comparing the combination with doublet platinum-based chemotherapy reported positive high-level results, demonstrating a statistically significant and clinically meaningful improvement in PFS and OS in August 2026.


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About TAGRISSO®

TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases.

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TAGRISSO® is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy. TAGRISSO® is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

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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 four 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.

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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 its expectations regarding the therapeutic potential of ORPATHYS®, the further clinical development for ORPATHYS®, its expectations as to whether any studies on ORPATHYS® 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. Forward-looking statements involve risks and uncertainties. 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 ORPATHYS®, including as a combination therapy, 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 market of ORPATHYS® for a targeted indication; the sufficiency of funding; HUTCHMED’s and AstraZeneca’s ability to successfully develop and commercialize ORPATHYS®. In addition, as certain studies rely on the use of other drug products such as TAGRISSO® as combination therapeutics with ORPATHYS®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. 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.

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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.

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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

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REFERENCES

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1

Lu S, et al. Osimertinib [osi] + savolitinib [savo] vs platinum–pemetrexed [plat–pem] in EGFRm MET-overexpressed [OE] and/or -amplified [AMP] advanced NSCLC post-osi: SAFFRON Phase [Ph] 3 primary results. Presented in a Proffered Paper session during Presidential Symposium II the European Society for Medical Oncology Congress 2026, 25 October at 16:45 CET.

2

Wu YL, et al. Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study. Presented at the European Society for Medical Oncology Congress 2026, 26 October at 08:30 CET.

3

World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed October 2026.

4

World Health Organization. International Agency for Research on Cancer. All Cancers Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf. Accessed October 2026.

5

American Cancer Society. What Is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2026.

6

Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688.

7

Gao X, et al. The safety and efficacy of osimertinib for the treatment of EGFR T790M mutation positive non-small-cell lung cancer. Expert Rev Anticancer Ther. 2016;16(4):383-390.

8

Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074)

9

Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. J Hematol Oncol. 2019;63.

10

De Marinis F, et al. Savolitinib plus osimertinib in epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer with MET overexpression and/or amplification following disease progression on osimertinib: primary results from the phase II SAVANNAH study. Ann Oncol. 2025;36(8):920-933.


Exhibit 99.2

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Graphic

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Press Release

HUTCHMED Highlights SANOVO Phase III Data for ORPATHYS® plus TAGRISSO® in First-Line EGFR-Mutated Lung Cancer Presented at ESMO Congress 2026

— ORPATHYS® plus TAGRISSO® reduced the risk of disease progression or death by 44% in the overall population and 55% in the high MET overexpression population in the first-line setting — 

— Robust PFS gains alongside very encouraging OS clinical benefit in this treatment-naïve biomarker-selected patient population — 

— Offers a potential new standard of care through an all-oral, biomarker-driven frontline strategy for MET-overexpressing, EGFR-mutated lung cancer patients — 

Hong Kong, Shanghai & Florham Park, NJ — Monday, October 26, 2026: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces positive results from the SANOVO Phase III trial in China. ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in the primary endpoint progression-free survival (“PFS”) versus TAGRISSO® alone in treatment-naïve patients with epidermal growth factor receptor-mutated (“EGFRm”) locally advanced or metastatic non-small cell lung cancer (“NSCLC”) and MET overexpression. The combination also demonstrated very encouraging clinical benefit in overall survival (“OS”), a secondary endpoint of the trial.

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These results have been presented in a Proffered Paper session at the 2026 European Society for Medical Oncology (“ESMO”) Congress in Madrid, Spain (abstract #LBA69).1

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PFS benefits were demonstrated in both the high MET (IHC 3+) and the intention-to-treat (“ITT”) trial populations (IHC 2+, IHC 3+). ORPATHYS® plus TAGRISSO® reduced the risk of disease progression or death by 44% compared to TAGRISSO® alone in the ITT population (based on a PFS hazard ratio [“HR”] of 0.56; 95% confidence interval [“CI”] 0.43-0.74; p<0.0001). The combination demonstrated a median PFS of more than two years (24.9 months) compared to approximately a year (13.8 months) for TAGRISSO® alone.

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In the high MET population, ORPATHYS® plus TAGRISSO® reduced the risk of disease progression or death by 55% compared to TAGRISSO® alone (PFS HR of 0.45; 95% CI 0.31-0.66; p<0.0001). ORPATHYS® plus TAGRISSO® extended median PFS by 13.7 months versus the comparator arm (24.8 versus 11.1 months).

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For the secondary endpoint of OS in the ITT population, ORPATHYS® plus TAGRISSO® showed a clinically meaningful improvement in OS (OS HR of 0.48; 95% CI 0.33-0.68) versus TAGRISSO® alone. ORPATHYS® plus TAGRISSO® extended median OS by 9.6 months versus the comparator arm (44.5 versus 34.9 months). An estimated 67.4% of patients treated with the combination were alive at three years compared to 47.4% in the comparator arm. With longer follow-up, the OS curves showed continued separation, signaling a greater magnitude of benefit over time for the ORPATHYS® plus TAGRISSO® combination. Importantly, the PFS and OS benefit observed was consistent across all prespecified ITT subgroups.

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Professor Yi-Long Wu of the Guangdong Provincial People's Hospital, and the leading principal investigator of the trial, said: “The SANOVO results mark a pivotal evolution in how we approach first-line EGFR-mutated lung cancer. Historically, co-occurring MET alterations have been associated with poor outcomes on EGFR-TKI treatment, increasing the motivation to test for MET alterations at diagnosis and upon progression. These potentially practice-changing results showed that adding savolitinib to osimertinib extended median PFS by more than a year in the high MET population, and 11 months overall, in first-line MET-overexpressing EGFR-mutated lung cancer. Coupled with highly encouraging clinical benefit in OS, these data reinforce the transformative potential of this all-oral, biomarker-directed treatment approach for a patient population where co-occurring MET overexpression may limit the long-term benefits of EGFR-TKI monotherapy.”

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Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said: “SANOVO, alongside the SAFFRON and SACHI studies, establishes a comprehensive treatment continuum for the ORPATHYS® plus TAGRISSO® combination — spanning frontline intervention to post-EGFR-TKI resistance. SANOVO demonstrates that by identifying MET overexpression at diagnosis and initiating an all-oral, dual-targeted combination upfront, we can meaningfully extend PFS and OS while preserving patient quality of life. SANOVO reinforces our strategy to improve long-term clinical outcomes for patients by advancing precision oncology into earlier lines of therapy.”

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Dr Jing He, Senior Vice President and Head of R&D China of AstraZeneca, said: “The SANOVO results build on the proven efficacy seen in SAFFRON and SACHI, bringing the benefit of ORPATHYS® plus backbone TAGRISSO® to first-line patients with EGFR-mutated lung cancer with co-occurring MET overexpression. By targeting both EGFR and MET pathways, this all-oral, biomarker-directed combination improved both progression-free and overall survival in this setting. These results allow us to further advance our strategy to redefine standards of care for patients with EGFR-mutated lung cancer by delivering novel, targeted combinations."

Summary of PFS and OS results: SANOVO i

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ORPATHYS® + TAGRISSO®

(n=162)

Placebo + TAGRISSO®

(n=164)

PFS (ITT) ii  

Number of patients with event, n (%)

101 (62.3)

124 (75.6)

Median PFS (95% CI) (in months)

24.9 (22.1-27.6)

13.8 (10.9-16.6)

HR (95% CI)

0.56 (0.43-0.74)

p-value

p<0.0001

PFS (IHC3+>90%)

Number of patients, n

98

98

Median PFS (95% CI) (in months)

24.8 (19.4-27.6)

11.1 (8.3-16.6)

HR (95% CI)

0.45 (0.31-0.66)

p-value

p<0.0001

OS (ITT) ii

Number of deaths, n (%)

49 (30.2)

83 (50.6)

Median OS (95% CI) (in months)

44.5 (41.3-NE iii)

34.9 (26.3-41.1)

HR (95% CI)

0.48 (0.33-0.68)

i PFS data cut-off was 31 July 2026. 

ii ITT = intention-to-treat (IHC 2+, IHC 3+)

iii NE = not estimable

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The safety profile for ORPATHYS® plus TAGRISSO® was manageable and consistent with the known profiles of each medicine, and there were no new safety concerns. Demonstrating strong long-term tolerability, treatment discontinuation due to adverse events occurred in only 14.8% of patients receiving ORPATHYS® plus TAGRISSO®. Most adverse events were manageable with dose adjustments, and fatal adverse event rates (excluding disease progression) were low and balanced across treatment arms (4.3% versus 4.8%).

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By simultaneously targeting EGFR and co-occurring MET pathway alterations at initial diagnosis, this chemotherapy-free, all-oral regimen intercepts bypass activation mechanisms before primary or early resistance emerges, offering robust clinical efficacy and sustained disease control while maintaining patient quality of life.

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An additional presentation featured during a Presidential Symposium at the ESMO Congress highlighted data from the SAFFRON Phase III trial of ORPATHYS® plus TAGRISSO® in MET-driven EGFRm NSCLC after progression on TAGRISSO® (abstract #LBA6). 2

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ORPATHYS® plus TAGRISSO® is approved in China for patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR-tyrosine kinase inhibitor (“TKI”) therapy based on the SACHI Phase III trial. Based on data from the SANOVO Phase III trial, HUTCHMED plans to submit a supplemental New Drug Application in China for this first-line setting.

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ORPATHYS® is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.

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About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death globally, accounting for almost one in four (23%) cancer deaths.3, 4 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.5 Approximately 75% of NSCLC patients are diagnosed with advanced disease.6 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.​7

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MET is a tyrosine kinase receptor that has an essential role in normal cell development.8 MET overexpression or amplification can lead to tumor growth and the metastatic progression of cancer cells.8, 9

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About SANOVO

SANOVO is a blinded, randomized, controlled Phase III trial in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression in China conducted by HUTCHMED. The study evaluates the efficacy and safety of ORPATHYS® in combination with TAGRISSO® compared to TAGRISSO® alone, a standard-of-care treatment option for these patients. A total of 326 treatment-naïve patients with locally advanced or metastatic NSCLC harbouring EGFR mutations (exon 19 deletion or L858R) and MET overexpression were randomized in a 1:1 ratio to receive TAGRISSO® 80 mg once daily plus either ORPATHYS® or placebo at 300/200 mg twice daily (dosed based on body weight).

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The primary endpoint of the trial is PFS as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, OS, objective response rate, duration of response, disease control rate, time to response and safety.

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About ORPATHYS®

ORPATHYS® (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It 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.

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ORPATHYS® is approved in China 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. ORPATHYS® also received a conditional approval in China for the treatment of adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. ORPATHYS® in combination with TAGRISSO® is approved in China for patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial. The combination was also granted a temporary authorization in Switzerland for the treatment of patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with TAGRISSO®. This was based on results from the global SAVANNAH Phase II trial. The global, randomized, SAFFRON Phase III trial in the same treatment setting comparing the combination with doublet platinum-based chemotherapy reported positive high-level results, demonstrating a statistically significant and clinically meaningful improvement in PFS and OS in August 2026.

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About TAGRISSO®

TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases.

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TAGRISSO® is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy. TAGRISSO® is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

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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 four 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.

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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 its expectations regarding the therapeutic potential of ORPATHYS®, the further clinical development for ORPATHYS®, its expectations as to whether any studies on ORPATHYS® 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. Forward-looking statements involve risks and uncertainties. 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 ORPATHYS®, including as a combination therapy, 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 market of ORPATHYS® for a targeted indication; the sufficiency of funding; HUTCHMED’s and AstraZeneca’s ability to successfully develop and commercialize ORPATHYS®. In addition, as certain studies rely on the use of other drug products such as TAGRISSO® as combination therapeutics with ORPATHYS®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. 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.

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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

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REFERENCES

1 Wu YL, et al. Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study. Presented at the European Society for Medical Oncology Congress 2026, 26 October at 08:30 CET.

2 Lu S, et al. Osimertinib [osi] + savolitinib [savo] vs platinum–pemetrexed [plat–pem] in EGFRm MET-overexpressed [OE] and/or -amplified [AMP] advanced NSCLC post-osi: SAFFRON Phase [Ph] 3 primary results. Presented in a Proffered Paper session during Presidential Symposium II the European Society for Medical Oncology Congress 2026, 25 October at 16:45 CET.

3 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed October 2026.

4 World Health Organization. International Agency for Research on Cancer. All Cancers Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf. Accessed October 2026.

5 American Cancer Society. What Is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2026.

6 Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688.

7 Gao X, et al. The safety and efficacy of osimertinib for the treatment of EGFR T790M mutation positive non-small-cell lung cancer. Expert Rev Anticancer Ther. 2016;16(4):383-390.

8 Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074)

9 Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. J Hematol Oncol. 2019;63


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