🇺🇸 SECHUTCHMED (China) LtdDoubao · 实盘不做把握 6/10不做原因:已被定价
北京时间·🕒 发布 18:22:54·⟳ 抓取 18:23:16 +22s·⚡ 决策 10-26 18:26:22 +3m06s·22.5 小时前
和黄医药ESMO公布SAFFRON/SANOVO两项III期完整数据（OS获益、NEJM同步发表、FDA NDA已递交），但核心阳性结果8月已公告并定价
两项III期阳性顶线结果分别在2026-08-17(SAFFRON，当日盘前+8.5%)和2026-08-31(SANOVO)已由公司一手公告并被市场定价，本次6-K是ESMO完整数据/NEJM发表及NDA递交的确认性披露（状态从'顶线阳性'推进到'完整数据+申报'，方向正面但预期差小）；港股今日数据时段不涨反跌约2.4%，美股盘前仅859股薄量推高约6.8%，会议数据见光死/高开低走风险高，合作方AZN为超大盘无弹性，无风险报酬合适的可执行多头。
📄 原文HUTCHMED (China) Ltd↗ 原文
----- hcm-20261026x6k.htm ----- 6-K 1 hcm-20261026x6k.htm 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Wash…
不做 HUTCHMED（HCM.US）
SAFFRON/SANOVO阳性顶线8月17日/8月31日已公告并定价（8/17盘前+8.5%），本次6-K为ESMO完整数据、NEJM发表与FDA NDA递交的确认性更新，预期差小；盘前仅约859股薄量高约6.8%，见光高开低走风险高，不追高
不做 和黄医药（00013.HK）
SANOVO完整数据今日港股盘中公布，股价收约22.56港元、较10/21回落约2.4%，市场对预期内的会议数据呈见光走弱；利好已在8月两次顶线公告中消化，短线无正期望
不做 AstraZeneca（AZN.US）
商业化主导方但为约2000亿美元级超大盘，ORPATHYS联合方案仅为EGFR管线增量、相对营收市值materiality极低，数据日主场反应约1%，无可交易弹性
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
结论摘要
SAFFRON/SANOVO数据本身强劲（OS HR 0.68/0.48，NEJM发表，FDA已报产），但阳性结论8月两度公告后已重估，本次属预期内的会议完整数据落地；港股盘中见光走弱、美股盘前薄量高开，追高风险报酬不佳，回避。
消息传播链
- SAFFRON完整PFS/OS数据公布并同步发表NEJM；新闻稿披露FDA NDA已递交、欧日申报推进中市场反应:港股10/26收22.56港元，较10/21的23.12回落约2.4%
- SANOVO完整数据（含OS HR 0.48、mOS 44.5 vs 34.9月）于港股盘中公布，公司计划中国递交sNDA市场反应:数据在港股交易时段发布，股价当日收跌约2.4%，见光走弱
- 2026-10-26 06:23 ET市场反应futu盘前报价非一手HCM.US盘前15.33美元、较前收14.36涨约6.8%，但盘前成交量仅859股（流动性极薄），高开低走风险大
关键理由
- 临床数据与监管层面确有实质推进：SAFFRON为该治疗领域首个同时显示PFS与OS显著获益的全球III期，FDA NDA已递交，SANOVO将方案延伸至一线（OS HR 0.48）
- 但8月17日/8月31日两次阳性顶线公告已完成主要风险消除，8月17日HCM盘前已涨约8.5%，本次为低预期差的确认性事件
主要风险
- 会议数据落地典型sell-the-news：SANOVO公布时段港股今日收跌约2.4%，美股盘前上涨仅由859股薄量驱动，开盘可能高开低走
- NDA/sNDA尚需受理与审批，SANOVO OS为次要终点、随访未成熟；和黄为分成方，ORPATHYS对其收入的实际增量与时间不确定
反向证据
- 做多前查反向 · 来源 web · 日期 2026-10-26 · 影响 weakens
SANOVO数据在港股交易时段公布后股价收跌约2.4%（22.56 vs 10/21的23.12），美股盘前仅859股薄量上涨；72小时内Bloomberg同场报道已含大摩对SAFFRON的谨慎提示与中国定价/竞品风险
检索:HUTCHMED ESMO SAFFRON SANOVO 股价 见光 风险 下调 竞品 MET 抑制剂 原文 ↗ - 做多前查反向 · 来源 web · 影响 weakens
ORPATHYS由AZN商业化、和黄收取里程碑与分成（历史里程碑1500万/2500万美元级），本次无新销售指引或金额，长期峰值弹性需待获批后兑现，短线业绩增量不可量化
检索:ORPATHYS savolitinib royalty AstraZeneca revenue share HUTCHMED economics 原文 ↗
先例如何影响了这次决策
对本次决策的影响:先例不足叠加价格已在顶线日反应，支持不追高、AVOID，而非给出ENTER
方向:未跑成外部event_study面板；最直接的参照是同一资产8月17日SAFFRON顶线首发（盘前+8.5%），说明阳性惊喜在顶线日已被捕捉，会议完整数据日属第二落点
涨幅量级:缺乏锚点干净的'顶线后会议数据/申报'对齐样本来校准本次剩余涨幅，不足以支持追高的tp/sl
形态:本次港股盘中对SANOVO数据收跌约2.4%、美股盘前薄量高开，本身构成见光走弱的即时证据
工具执行结果 · 成功 5 · 降级 2 · 失败 0 · 取消 0
- search_processed_events 成功 stock_tools HTTP · 215 ms
{"result": "search_processed_events:agent query=`hutchmed saffron phase iii pfs os positive results august 2026 | hutchmed 和黄医药 saffron 赛沃替尼 savolitinib tagrisso 三期 esmo | sanovo phase iii orpathys osimertinib first-line egfr met`；结构化索引覆盖完整 72 小时；旧记录兼容扫描近 68.2/72 小时、2457 条本臂决策(完整)，返回 1 条候选。\n• 10-26 - fetch_decision_experience 成功 stock_tools_inprocess · 2 ms
{ - stock_quote 降级 stock_tools HTTP · 121 ms
{ - stock_quote 降级 stock_tools HTTP · 811 ms
{ - web_search 成功 doubao_search · 1,505 ms
豆包搜索结果（原始查询:HUTCHMED SANOVO phase 3 savolitinib osimertinib first-line topline results announcement；API SearchType:web） - web_search 成功 doubao_search · 1,508 ms
豆包搜索结果（原始查询:HUTCHMED savolitinib royalty AstraZeneca sales economics ORPATHYS partnership terms；API SearchType:web） - web_search 成功 doubao_search · 1,352 ms
豆包搜索结果（原始查询:和黄医药 赛沃替尼 SAFFRON 8月 阳性 顶线结果 股价 ORPATHYS topline August 2026 HUTCHMED；API SearchType:web）
原文全文
展开原文 · 37,532 字
----- hcm-20261026x6k.htm -----
6-K
1
hcm-20261026x6k.htm
6-K
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 October 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
Exhibit 99.1
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
Exhibit 99.2
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
2
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
By:
/s/ Johnny Cheng
Name:
Johnny Cheng
Title:
Chief Financial Officer
Date: October 26, 2026
3
----- hcm-ex99d1.htm -----
EX-99.1
2
hcm-ex99d1.htm
EX-99.1
Exhibit 99.1
Press Release
HUTCHMED Highlights SAFFRON Global Phase III Data Presented at ESMO Congress 2026 and Simultaneously Published in The New England Journal of Medicine
— 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 —
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
®
.
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.
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.
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.
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.”
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.”
Summary of PFS and OS results: SAFFRON
i
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
11
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
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).
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.
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
ORPATHYS
®
is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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
__________________________________________
REFERENCES
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.
----- hcm-ex99d2.htm -----
EX-99.2
3
hcm-ex99d2.htm
EX-99.2
Exhibit 99.2
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
®
reduc
e
d 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.
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
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.
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).
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.
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.”
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.”
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
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
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%).
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.
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
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.
ORPATHYS
®
is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.
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
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
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).
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.
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.
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.
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.
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.
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.
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.
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
_____________________________________
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
6-K
1
hcm-20261026x6k.htm
6-K
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 October 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
Exhibit 99.1
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
Exhibit 99.2
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
2
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
By:
/s/ Johnny Cheng
Name:
Johnny Cheng
Title:
Chief Financial Officer
Date: October 26, 2026
3
----- hcm-ex99d1.htm -----
EX-99.1
2
hcm-ex99d1.htm
EX-99.1
Exhibit 99.1
Press Release
HUTCHMED Highlights SAFFRON Global Phase III Data Presented at ESMO Congress 2026 and Simultaneously Published in The New England Journal of Medicine
— 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 —
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
®
.
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.
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.
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.
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.”
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.”
Summary of PFS and OS results: SAFFRON
i
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
11
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
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).
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.
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
ORPATHYS
®
is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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
__________________________________________
REFERENCES
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.
----- hcm-ex99d2.htm -----
EX-99.2
3
hcm-ex99d2.htm
EX-99.2
Exhibit 99.2
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
®
reduc
e
d 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.
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
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.
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).
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.
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.”
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.”
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
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
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%).
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.
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
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.
ORPATHYS
®
is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.
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
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
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).
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.
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.
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.
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.
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.
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.
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.
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
_____________________________________
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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