Savolitinib Plus Cetuximab and FOLFOX Chemotherapy Versus Cetuximab and FOLFOX Chemotherapy as First-line Treatment for RAS/BRAF Wild-type Metastatic Colorectal Cancer: a Prospective, Randomized, Controlled, Multicenter, Open-label Study

The goal of this clinical trial is to learn if adding savolitinib to cetuximab plus FOLFOX chemotherapy works as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer, and to evaluate its safety. The main questions it aims to answer are:
Does the addition of savolitinib improve the objective response rate (ORR) compared to cetuximab plus FOLFOX alone?
What medical problems (adverse events) do participants experience when taking savolitinib in combination with cetuximab and FOLFOX?
Researchers will compare savolitinib plus cetuximab and FOLFOX (experimental group) versus cetuximab and FOLFOX alone (control group) to see if the triplet regimen provides better tumor response and survival outcomes.
Participants will:
Take oral savolitinib once daily in repeated 14-day cycles (or receive control treatment), combined with weekly cetuximab and bi-weekly FOLFOX chemotherapy
Visit the clinic every 2 weeks or 4 weeks for treatment administration, safety monitoring, and laboratory tests
Undergo tumor imaging assessments every 8 weeks (4 cycles) to evaluate treatment response and disease progression
Have regular follow-up visits for 30 days after the last dose, and then every 3 months for survival follow-up

Start Date30 Jun 2026

Sponsor / Collaborator

Fudan University

CTR20261803

/ RecruitingPhase 3

评价赛沃替尼对比紫杉醇治疗伴MET基因扩增的局部晚期或转移性胃癌和胃食道连接部腺癌患者疗效和安全性的随机、对照、开放标签、多中心III期临床研究

[Translation] A randomized, controlled, open-label, multicenter phase III clinical trial evaluating the efficacy and safety of cerovatinib versus paclitaxel in patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma with MET gene amplification.

1. 评价赛沃替尼对比紫杉醇治疗MET基因扩增的局部晚期或转移性胃癌及胃食道连接部腺癌患者的临床疗效；2 评价赛沃替尼对比紫杉醇治疗MET基因扩增的局部晚期或转移性胃癌及胃食道连接部腺癌患者的其他临床疗效；3评价赛沃替尼对比紫杉醇治疗MET基因扩增的局部晚期或转移性胃癌及胃食道连接部腺癌患者的安全性和耐受性； 4 评价赛沃替尼对比紫杉醇对患者生活质量评分的影响。

[Translation]

1. To evaluate the clinical efficacy of cefertinib versus paclitaxel in treating patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma with MET gene amplification; 2. To evaluate other clinical efficacy of cefertinib versus paclitaxel in treating patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma with MET gene amplification; 3. To evaluate the safety and tolerability of cefertinib versus paclitaxel in treating patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma with MET gene amplification; 4. To evaluate the impact of cefertinib versus paclitaxel on patients' quality of life scores.

Start Date15 Jun 2026

Sponsor / Collaborator

Hutchison MediPharma Ltd.

NCT06692491

/ Not yet recruitingPhase 2IIT

A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS)

The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug screening.

Start Date01 Jan 2025

Sponsor / Collaborator

Peking University Shenzhen Hospital

100 Clinical Results associated with Savolitinib

100 Translational Medicine associated with Savolitinib

100 Patents (Medical) associated with Savolitinib

216

Literatures (Medical) associated with Savolitinib

31 Dec 2026·RENAL FAILURE

A tri-scale in silico framework integrating pharmacovigilance and mechanistic modeling suggests tepotinib-associated acute kidney injury risk

Article

Author: Bai, Zhixun ; Wang, Qin ; Zheng, Rubin ; Han, Jinfen ; Lyu, Jiayi ; Lu, Jing ; Deng, Miao ; Chen, Jiaxi

Proactive safety evaluation of molecularly targeted therapies requires generalizable frameworks that integrate real-world evidence with mechanistic insights. As a case in point, tepotinib, a mesenchymal-epithelial transition (MET) inhibitor for non-small cell lung cancer, has a known pulmonary toxicity profile, but its link to acute kidney injury (AKI) and underlying mechanism remain unclear. We devised a tri-scale in silico strategy encompassing population-scale pharmacovigilance signal extraction from the FDA Adverse Event Reporting System (FAERS) (2020-2025) via disproportionality analysis (Reporting Odds Ratio, ROR, and Proportional Reporting Ratio, PRR), network toxicology-based multi-target exploration for shared target and hub gene identification, and mechanistic docking-based molecular plausibility assessment using the Cavity-detection guided Blind Docking (CB-Dock2) platform. Pharmacovigilance analysis identified a significant renal impairment signal (ROR = 20.60). Network toxicology suggested potential nephrotoxicity and revealed 173 shared targets and prioritizing six hub genes (HSP90AA1, AKT1, EGFR, CASP3, TNF, SRC). These genes were shown to be critically involved in PI3K-Akt and MAPK pathways. Molecular docking revealed high-affinity binding between tepotiniband all six hub targets (Vina scores: -8.0 to -10.6 kcal/mol), providing a structural basis for the postulated mechanistic link to AKI. These findings not only highlight the necessity for enhanced renal monitoring in tepotinib-treated patients but, more broadly, establish the FAERS-NetDock Pipeline as a reusable, generalizable and hypothesis-generating framework for evaluating tyrosine kinase inhibitors (TKIs)-induced nephrotoxicity; this framework is immediately applicable to profiling the safety of other TKIs (e.g. crizotinib, capmatinib, savolitinib, afatinib and osimertinib) and is readily adaptable for de-risking a wider spectrum of targeted therapies.

21 Apr 2026·CURRENT DRUG METABOLISM

Advancing MET-Aberrant NSCLC Therapy with Glumetinib: Pharmacokinetics, Efficacy, Safety, Drug Interactions, and Clinical Prospects.

Article

Author: Yin, Xiaoyu ; Zhang, Zhiqing ; Lu, Ming

Targeting Mesenchymal-Epithelial Transition Factor (MET) gene aberrations has emerged as a pivotal strategy in the precision treatment of Non-Small Cell Lung Cancer (NSCLC). Among these, MET exon 14 (METex14) skipping mutation represents a well-established and significant therapeutic target. Glumetinib, a highly selective oral MET inhibitor developed in China, has been approved by the National Medical Products Administration (NMPA) and the Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of advanced or relapsed NSCLC with METex 14 skipping mutation. Glumetinib has not yet received approval from the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). However, a phase II clinical trial is ongoing in the United States, planning to enroll 78 patients with advanced c-MET-positive NSCLC, which may support future regulatory submissions. Preclinical investigations have shown that glumetinib effectively inhibits MET-driven tumors by specifically targeting c-Met kinase activity and its associated downstream signaling pathways. In the pivotal phase II GLORY trial, patients with METex14-positive NSCLC were administered glumetinib (300 mg/day) and demonstrated an Objective Response Rate (ORR) of 66% and a median Progression-Free Survival (PFS) of 8.5 months. Notably, patients with brain metastases exhibited an ORR of 85%. Treatment-Related Adverse Events (TRAEs) of grade≥3 severity were reported in 54% of patients, with only 8% discontinuing treatment due to TRAEs, suggesting a manageable safety profile. From the perspective of China's healthcare system, glumetinib is considered more cost-effective than savolitinib in treating NSCLC patients with METex14 skipping. The clinical applications of glumetinib are broadening to encompass strategies to overcome drug resistance and combination therapies. This manuscript seeks to provide a comprehensive overview of the essential characteristics, mechanism of action, pharmacokinetics, efficacy, safety, drug interactions, and cost-effectiveness of glumetinib while also exploring its future therapeutic potential.

20 Apr 2026·JOURNAL OF CLINICAL ONCOLOGY

CALYPSO: Final Results of Savolitinib and Durvalumab Combination in Metastatic Papillary Renal Cancer

Article

Author: Patel, Poulam ; Powles, Thomas ; Mendez-Vidal, Maria Jose ; Rodriguez-Vida, Alejo ; Ralph, Christy ; Thistlethwaite, Fiona C. ; Gascó, Amaya ; Srinivasan, Gopalakrishnan ; Szabados, Bernadett E. ; Hartmaier, Ryan ; Valderrama, Begoña P. ; Glen, Hilary ; Childress, Merrida ; Jackson-Spence, Francesca ; Markovets, Aleksandra ; Suárez, Cristina ; Larkin, James ; Jamal, Fahmida ; Ackerman, Charlotte ; Boyle, Patrick ; Priyadarshini, Garima ; Li, Wenshu

PURPOSE:

The CALYPSO study demonstrated activity of savolitinib and durvalumab in MET -driven papillary renal cancer (PRC). We report final efficacy outcomes and exploratory circulating tumor DNA (ctDNA) biomarker analysis.

METHODS:

This single-arm phase II study evaluated savolitinib and durvalumab in treatment-naïve or pretreated PRC. End points included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). FoundationOne CDx assessed DNA alterations and MET /PD-L1 or MET /tumor mutational burden (TMB) copositivity. ctDNA collected at baseline and on treatment was correlated with outcomes.

RESULTS:

At 41-months median follow-up, ORR was 34% (95% CI, 20.0 to 51.0) in the intention-to-treat (ITT) population (N = 41) and 53% (95% CI, 28.0 to 77.0) in MET -driven patients (n = 17). Median PFS was 6.5 (95% CI, 2.7 to 12.0) versus 13.9 months (95% CI, 2.9 to 23.8), and OS was 18.3 (95% CI, 7.3 to 30.7) versus 27.4 months (95% CI, 9.3 to 37.4), in the ITT population and the MET -driven population, respectively. PD-L1 (66% positive) and TMB (median 2.5 mut/Mb) status did not correlate with response. Baseline ctDNA positivity (10/21) correlated with shorter OS (median 7.3 v 33.3 months), while ctDNA clearance and mean variant allele frequency reduction correlated with improved OS (median 31.3 v 7.2 and 31.3 v 15.5 months, respectively).

CONCLUSION:

Savolitinib plus durvalumab shows OS in MET -driven PRC, supporting the ongoing SAMETA RIII trial (ClinicalTrials.gov identifier: NCT05043090 ). ctDNA may be a useful predictive biomarker.

136

News (Medical) associated with Savolitinib

30 Jul 2026

·www.globenewswire.com

HUTCHMED Reports 2026 Interim Results

— China product sales recovery continues led by ELUNATE® and SULANDA® with over 40% growth each — — FRUZAQLA® ex-US sales driving growth – now approved or launched in 41 countries — — Strong progress in ATTCs, a source of novel drug candidates with broad therapeutic potential — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 30, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the six months ended June 30, 2026 and provides updates on key clinical and commercial developments. All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 25. Global sales growth driven by China rebound and FRUZAQLA® geographical expansion In-market sales from key China commercial products up over 40% compared to the first half of 2025. ELUNATE® (fruquintinib in China) up 41% to $60.8 million as it expanded reimbursement coverage for endometrial cancer and was approved for kidney cancer. SULANDA® up 45% to $18.4 million, boosted by upgraded recommendation in Chinese Society of Clinical Oncology guidelines for neuroendocrine tumors.In-market sales of FRUZAQLA® (fruquintinib ex-China) ex-US up ~70% to $68.9 million during first half of 2026, alongside steady US sales, driven by the need for novel non-chemo treatment options in mCRC and ongoing positive experiences of oncologists in third line setting.Profitability maintained amid higher R&D investment, with net income attributable to HUTCHMED at $15.9 million (H1-25: $455.0m including $416.3m gain on divestment of 45% of Shanghai Hutchison Pharmaceuticals Limited (SHPL)), which allowed the Company to maintain a strong cash balance of $1.37 billion. Multiple first-in-class Antibody-Targeted Therapy Conjugate (ATTC) candidates in clinical trials Initiated clinical trial of HMPL-A251 (PI3K/PIKK-HER2) in December 2025 and of HMPL-A580 (PI3K/PIKK-EGFR) in March 2026 and presented preclinical data at American Association for Cancer Research Annual Meeting. Both ATTCs are progressing through dose escalation as planned.HMPL-A830 clinical trial application approved in July 2026, based on a different ATTC payload platform. Regulatory and clinical achievements across late-stage clinical portfolio New Drug Application (NDA) approval of ELUNATE® with sintilimab for second-line kidney cancer in China in May 2026, supported by FRUSICA-2 Phase III data showing median progression-free survival (PFS) of 22.2 months vs. 6.9 months in control group.NDA acceptance of sovleplenib for warm autoimmune hemolytic anemia (wAIHA) in China in April 2026, supported by ESLIM-02 Phase III data presented at European Hematology Association Congress with durable response rate of 66.0%, along with NDA acceptance for immune thrombocytopenia (ITP) in China in February 2026; both wAIHA and ITP indications received priority review status.Positive SACHI Phase III data of ORPATHYS® in combination with TAGRISSO® (osimertinib) sub-group analysis published in The Lancet in January 2026 with median overall survival (OS) of 22.9 months vs. 7.9 months with chemotherapy. NDA approval for third-line MET-amplified gastric cancer in China in June 2026, supported by Phase II data presented at American Society of Clinical Oncology Annual Meeting with objective response rate of 32.3%.Positive pivotal Phase II data of fanregratinib (FGFR inhibitor) in intrahepatic cholangiocarcinoma presented at European Society for Medical Oncology Gastrointestinal Cancers Congress.Initiated Phase III trial of HMPL-760 (BTK inhibitor) in combination with rituximab and chemotherapy for second-line diffuse large B-cell lymphoma in March 2026. HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday, July 30, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, July 31, 2026. After registration, investors may access the live webcast at www.hutch-med.com/event. Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “HUTCHMED has a clear strategic focus: to build a globally competitive oncology portfolio anchored by differentiated innovation. This future is shaped by our global first-in-class Antibody-Targeted Therapy Conjugate (ATTC) novel payload platforms and other emerging large-molecule modalities. These give us multiple opportunities to pursue first-in-class or best-in-class assets, with potential to be used in combination with standard-of-care or newer medicines, in turn conferring front-line treatment prospects. As these programs advance, multinational partnerships – some presently under discussion – can provide important external validation, broaden development reach and accelerate access to major international markets. We will continue to invest in our world-class R&D organization and deploy our resources in areas where HUTCHMED can create significant impact on the lives of patients globally, harnessing the most advanced scientific modalities, while creating commercial and shareholder value.” Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, “Strong in-market sales growth from ELUNATE® and SULANDA® in the first half reflects the impact of last year’s streamlining of our salesforce, enhancing productivity with more focused marketing strategies, as we structured our commercial organization to meet the changing China market regulatory guidelines for a sustainable future. We are accelerating ATTC development and strengthening discovery operations through expanding talent and AI capabilities. We are also pursuing business development discussions with multinational partners to expedite global development and commercialization of our most promising programs.” Dr Weiguo Su, Chief Executive Officer (currently on leave of absence) and Chief Scientific Officer of HUTCHMED, said, “The acceptance by the NMPA of the NDA filings for sovleplenib in ITP and wAIHA during the first half of 2026 reflects the strength of the clinical data package, supporting its potential for regulatory and commercial success. Sovleplenib once again attests to the importance of target selectivity, differentiating efficacy and toxicity profiles of our assets. Our ATTC drug candidates are guided by the same principles, designed to navigate our proprietary potent small-molecule targeted therapy payloads to tumor cells while sparing healthy tissues and decreasing side-effects. Pre-clinical data has shown encouraging tumor shrinkage as compared to standard-of-care treatments and emerging therapies recently launched or in development. With three highly novel molecules from two ATTC payload platforms progressing through or about to start first-in-human clinical development, and additional candidates advancing behind them, we are building a science-driven pipeline designed to translate differentiated biology into meaningful clinical benefit.” 2026 INTERIM RESULTS & BUSINESS UPDATES I. COMMERCIAL OPERATIONS There was a strong rebound in China in-market sales, achieving $94.4 million in H1 2026, up 32% vs H1 2025 ($71.6 million) as our sales team continues to improve productivity. This contributed to total in-market sales for oncology products of $279.8 million in H1 2026 (H1-25: $234.4 million). ELUNATE® in-market sales were up 41% to $60.8 million, successfully expanded NRDL coverage to include 2L EMC with pMMR in combination with sintilimab. It also renewed coverage in metastatic CRC for patients who have been previously treated with chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF or anti-EGFR (RAS wild-type). SULANDA® in-market sales were up 45% to $18.4 million, driven by an update to Chinese Society of Clinical Oncology guidelines upgrading the usage for SULANDA® in neuroendocrine tumors to the highest Level I recommendation standard over competing SSA products. It also benefited from shifting marketing strategies to focus on key hospitals. FRUZAQLA® in-market sales growth was primarily driven by sales outside the US, which had growth of ~70%, contributed by approvals or launches in 41 countries to date, including securing reimbursement in France in Q1 2026 and late 2025 launches in Portugal, Belgium, South Korea and Mexico. This helped boost global in-market sales to $185.4 million. Total consolidated revenue for oncology products increased 23% to $121.4 million as compared to H1 2025, primarily due to strong in-market sales growth in ELUNATE® and SULANDA®. Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was $40.9 million, including an $18.1 million milestone payment from Eli Lilly, triggered by China approval for 2L RCC. Other Ventures revenue, mainly from prescription drug distribution was $116.0 million, leading to total consolidated revenue of $278.3 million. ($ in millions)In-market Sales*Consolidated Revenue** H1 2026H1 2025% Change(CER)H1 2026H1 2025% Change (CER)FRUZAQLA®$185.4$162.8+14%(+14%)$43.1$43.1— —ELUNATE®$60.8$43.0+41%(+33%)$47.1$33.6+40%(+32%)SULANDA®$18.4$12.7+45%(+37%)$18.4$12.7+45%(+37%)ORPATHYS®$15.7$15.2+3%(-3%)$13.3$9.0+48%(+39%)TAZVERIK®***$(0.5)$0.7— —$(0.5)$0.7— —Oncology Products$279.8$234.4+19%(+17%)$121.4$99.1+23%(+18%)Takeda upfront, regulatory milestones and R&D services$20.7$29.5-30%(-30%)Other revenue (R&D services and licensing)$20.2$14.9+35%(+35%)Total Oncology/Immunology$162.3$143.5+13%(+10%)Other Ventures$116.0$134.2-14%(-19%)Total Revenue$278.3$277.7— (-4%) * FRUZAQLA®, ELUNATE® and ORPATHYS® mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively. ** FRUZAQLA® represents manufacturing revenue and royalties paid by Takeda to HUTCHMED; ELUNATE® represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS® represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA® and TAZVERIK® represent HUTCHMED’s sales of the products to third parties.*** Ipsen is the Marketing Authorization Holder for TAZVERIK®, for which HUTCHMED acts as domestic agent/licensee. In March 2026 Ipsen voluntarily withdrew TAZVERIK® from all Ipsen markets, effective immediately, following emerging safety data from the ongoing SYMPHONY‑1 trial. II. 2026 REGULATORY UPDATES Savolitinib sNDA approved by NMPA in 3L MET-amplified GC in June 2026.Savolitinib MAA approved (temporary authorization) by Swissmedic in combination with TAGRISSO® for 2L EGFRm NSCLC with MET amplification and/or overexpression in February 2026.Fruquintinib sNDA approved by NMPA in combination with sintilimab for 2L RCC in May 2026.Sovleplenib NDA accepted by NMPA for 2L wAIHA in April 2026.Sovleplenib NDA resubmission accepted by NMPA for 2L ITP in February 2026.Tazemetostat voluntary withdrawal by Ipsen in China in March 2026. III. 2026 LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET Expecting topline results in H2 2026 for SAFFRON and SANOVO, following full enrollment in H2 2025: SAFFRON global Phase III study for 2L/3L EGFRm NSCLC patients with MET amplification and/or overexpression could support global filings (NCT05261399).SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression could support China filing (NCT05009836). Published sub-group analysis of SACHI China Phase III study for 2L EGFRm NSCLC patients with MET amplification in The Lancet in January 2026, showing mOS of 22.9 months vs 7.9 months with chemotherapy (HR 0.32) when excluding control group patients who received subsequent MET inhibitor.Presented and published positive China Phase II pivotal study data in 3L MET-amplified GC at ASCO 2026 and in Nature Medicine in June 2026, respectively, with IRC-assessed ORR of 32.3%, mPFS of 4.0 months and mOS of 6.9 months (NCT04923932). Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk Presented positive ESLIM-02 China Phase III study data in 2L wAIHA at EHA 2026 Congress in June 2026, having met its primary endpoint of durable response rate of 66.0%, showing median time to response of 3.1 weeks and median cumulative duration of response of 16.1 weeks. Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Presented positive China Phase II pivotal study data in 2L FGFR2 fusion/rearrangement ICC at ESMO Gastrointestinal Cancers Congress in July 2026, having met its primary endpoint of IRC-assessed ORR of 42.5%, as well as showing mPFS of 6.9 months and mOS of 16.6 months. An NDA for 2L ICC was accepted by NMPA with priority review status in December 2025 (NCT04353375). HMPL-760, a non-covalent, third generation BTK inhibitor, targeting wild-type and C481S-mutated BTK Initiated China Phase III study in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with 2L relapsed/refractory DLBCL versus placebo in combination with R-GemOx in March 2026 (NCT07409428). Primary endpoints are investigator-assessed PFS and OS. IV. ANTIBODY-DRUG CONJUGATES RESEARCH & DEVELOPMENT HMPL-A251, a first-in-class PI3K/PIKK-HER2 ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker Progressing a dose-escalation and expansion trial for unresectable, advanced or metastatic HER2-expressing solid tumors with first patient dosed in December 2025 (NCT07228247).Preclinical data showed anti-tumor activity in DXd-resistant cell line and good efficacy and safety when in combination with chemotherapy via a differentiated mechanism of action. HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to an anti-EGFR IgG1 antibody, via a cleavable linker Progressing a dose-escalation and expansion trial for solid tumors, including NSCLC, CRC, HNSCC and ESCC with first patient dosed in March 2026 (NCT07396584).Preclinical data presented at AACR 2026 showing tumor shrinkage in osimertinib-resistant EGFRm NSCLC cell line and good efficacy and safety when used in combination with osimertinib in EGFRm PAM non-altered NSCLC cell line. HMPL-A830 China/US INDs cleared Plans for global clinical trial initiation in H2 2026. Preclinical data showed superior potency and safety profiles to antibodies or small molecules with the same target, with data to be presented at a scientific conference. V. COLLABORATION UPDATES ImageneBio is developing IMG-007, a non-T cell depleting, antibody-dependent cell-mediated cytotoxicity -silenced OX40 antagonist discovered by HUTCHMED Phase IIb trial (NCT07037901) in patients with moderate-to-severe atopic dermatitis progressing, with an amended protocol and topline data anticipated in the fourth quarter of 2027.Phase II trial initiation in patients with alopecia areata expected in 2026, with initial data expected in 2028. VI. OTHER VENTURES Other Ventures consolidated revenue decreased to $116.0 million for the six months ended June 30, 2026 (H1-25: $134.2 million) which has minimal impact on profitability as the segment is predominantly low-margin prescription drug distribution business in China and HUTCHMED continues to optimize working capital management.Consolidated net income attributable to HUTCHMED from Other Ventures decreased to $3.8 million (H1-25: $24.0m), primarily due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025. VII. SUSTAINABILITY The 2025 Sustainability Report was published in April 2026 alongside the 2025 Annual Report. We have initiated a new target-setting cycle. A list of potential focus initiatives has been identified under our five sustainability pillars: Innovation, Climate Action, Human Capital, Access to Healthcare, and Ethics and Transparency. In 2026, we will develop this into a final list, including a roadmap for achievement and monitoring. In 2026, our sustainability initiatives have continued to receive strong recognition. Most recently, our commitment was reflected in an upgraded AA rating by MSCI, recognizing HUTCHMED as a Leader, and placing us among the top 19% of pharmaceutical companies. For its second consecutive year, HUTCHMED was recognized as Most Honored Company and ranked 1st place in ESG in its sector by Extel, formerly Institutional Investor Research, in its 16th Asia Executive Team Survey. It achieved top rankings across several areas – leading CEO, CFO, Investor Relations, ESG and Corporate Governance – earning the Most Honored Company designation. HUTCHMED was the only company to earn these designations in 2026 in All Asia (ex-Mainland China) Biopharmaceuticals. FINANCIAL HIGHLIGHTS Revenue for the six months ended June 30, 2026 was $278.3 million compared to $277.7 million for the six months ended June 30, 2025. Oncology/Immunology consolidated revenue amounted to $162.3 million (H1-25: $143.5m): ELUNATE® revenue was $47.1 million, up 40% (H1-25: $33.6m), comprising manufacturing revenue, promotion and marketing services revenue and royalties, supported by ongoing label expansions.SULANDA® revenue was $18.4 million, up 45% (H1-25: $12.7m), driven by marketing strategies focusing on key hospitals and supported by recent oncology clinical guideline upgrades.ORPATHYS® revenue was $13.3 million, up 48% (H1-25: $9.0m), driven by higher manufacturing sales to AstraZeneca in preparation for the 3L MET-amplified GC launch.FRUZAQLA® revenue was $43.1 million (H1-25: $43.1m), reflecting continued growth in royalties, offset by reduced manufacturing revenue compared to the prior period, driven by strong in-market sales growth following approvals/launches in 41 countries to date.Takeda upfront, regulatory milestones and R&D services revenue were $20.7 million (H1-25: $29.5m), due to less R&D and regulatory support services to Takeda.Other revenue of $20.2 million (H1-25: $14.9m), includes an $18.1 million milestone payment from Eli Lilly triggered by China approval of ELUNATE® in combination with sintilimab for 2L RCC (H1-25: $11.1 million regulatory milestone from AstraZeneca following China NDA approval for SACHI). Other Ventures consolidated revenue of $116.0 million (H1-25: $134.2m), primarily due to scaling down low-margin logistics distribution sales after considering working capital. Net Expenses for the six months ended June 30, 2026 were $262.4 million compared to $239.0 million for the six months ended June 30, 2025. Cost of Revenue was $152.2 million (H1-25: $167.6m), predominantly due to a lower cost of sales related to the prescription drug distribution business. Cost of revenue as a percentage of oncology product revenue improved to 33% (H1-25: 39%) driven by enhanced productivity and efficiency.R&D Expenses were $78.8 million (H1-25: $72.0m) as we initiated early-stage global clinical programs for our ATTC assets and we maintain ongoing investment in discovery to deliver sustained innovation.S&A Expenses were $46.5 million (H1-25: $41.6m), driven by strong performance of our Oncology/Immunology commercial operations and enhanced productivity.Other Items generated net income of $15.1 million (H1-25: $42.2m), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes. The decrease was mainly due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025. Net Income attributable to HUTCHMED for the six months ended June 30, 2026 was $15.9 million compared to $455.0 million for the six months ended June 30, 2025. $0.02 basic earnings per ordinary share / $0.09 basic earnings per ADS in the first half of 2026 (H1-25: $0.53 basic earnings per ordinary share / $2.65 basic earnings per ADS). Cash, Cash Equivalents and Short-Term Investments were $1,374.8 million as of June 30, 2026 compared to $1,367.3 million as of December 31, 2025. Adjusted Group (non-GAAP) net cash inflow excluding financing activities in the first half of 2026 was $10.5 million mainly due to net income of $16.2 million less $5.6 million in capital expenditures (H1-25: net cash inflow of $519.1m mainly due to the $549.0m net proceeds from the partial divestment of SHPL less a $10.0m regulatory approval milestone payment and $9.2m in capital expenditures).Net cash used in financing activities in the first half of 2026 totaled $2.9 million mainly due to net repayments of bank borrowings (H1-25: net cash inflow of $9.3m mainly due to proceeds from bank borrowings of $8.2m). Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 5% during the first half of 2026, which has impacted consolidated financial results as highlighted. Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. FINANCIAL GUIDANCE HUTCHMED reiterates full year 2026 guidance for Oncology/Immunology consolidated revenue in the range of $330 million to $450 million. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities. Shareholders and investors should note that: The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; andThe Company has in the past revised its financial guidance and reference should be made to announcements it publishes regarding any updates to the financial guidance after the publication of this announcement. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data (in $’000)As of June 30, 2026 As of December 31, 2025Assets(Unaudited) Cash and cash equivalents and short-term investments1,374,817 1,367,275Accounts receivable117,556 126,750Other current assets61,036 73,317Property, plant and equipment93,788 94,623Investment in equity investees11,020 10,865Other non-current assets78,210 80,267Total assets1,736,427 1,753,097Liabilities and shareholders’ equityAccounts payable33,646 45,533Other payables and accruals197,627 208,892Bank borrowings94,508 93,160Deferred revenue27,630 51,547Other liabilities108,048 102,703Total liabilities461,459 501,835Company’s shareholders’ equity1,260,776 1,237,926Non-controlling interests14,192 13,336Total liabilities and shareholders’ equity1,736,427 1,753,097 Condensed Consolidated Statements of Operations Data (Unaudited, in $’000, except share and per share data)Six months ended June 30, 2026 2025Revenue:Oncology/Immunology – Marketed Products121,434 99,039 Oncology/Immunology – R&D40,887 44,408 Oncology/Immunology Consolidated Revenue162,321 143,447 Other Ventures115,966 134,230 Total revenue278,287 277,677 Operating expenses:Cost of revenue(152,158) (167,577)Research and development expenses(78,783) (71,990)Selling and administrative expenses(46,477) (41,624)Total operating expenses(277,418) (281,191) Gain on divestment of an equity investee— 477,456 Other income, net12,784 21,650 Income before income taxes and equity in earnings of equity investees13,653 495,592 Income tax expense(1,209) (2,029)Income tax expense – Divestment of an equity investee— (61,133)Equity in earnings of equity investees, net of tax3,798 23,125 Net income16,242 455,555 Less: Net income attributable to non-controlling interests(314) (601)Net income attributable to HUTCHMED15,928 454,954 Earnings per share attributable to HUTCHMED (US$ per share)– basic 0.02 0.53 – diluted0.02 0.52 Number of shares used in per share calculation– basic865,770,498 857,038,725 – diluted872,869,494 872,564,513 Earnings per ADS attributable to HUTCHMED (US$ per ADS)– basic 0.09 2.65 – diluted0.09 2.61 Number of ADSs used in per ADS calculation– basic173,154,100 171,407,745 – diluted174,573,899 174,512,903 About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, and 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. Contacts Investor Enquiries+852 2121 8200 /ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 /HUTCHMED@fticonsulting.comBen Atwell / Tim Stamper+44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) /HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerDuncan Monteith / Ramin Naji+44 20 7545 8000 References Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context. Past Performance and Forward-Looking Statements The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement 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 can be identified by words like “will”, “expects”, “anticipates”, “future”, “intends”, “plans”, “believes”, “estimates”, “pipeline”, “could”, “potential”, “first-in-class”, “best-in-class”, “designed to”, “objective”, “guidance”, “pursue”, or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the delay or inability of a drug candidate to meet the primary or secondary endpoint of a study; the delay or inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains, including various third party services, for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability to obtain additional funding when needed; the ability to obtain and maintain protection of intellectual property for HUTCHMED’s Products and drug candidates; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates, uncertainties in global interest rates, and geopolitical relations, sanctions and tariffs. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above. Inside Information This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018). Medical Information This announcement 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. This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/031c06fc-010c-45d1-8c53-ed93a7275b6c

Phase 2Clinical ResultPhase 3Drug ApprovalPhase 1

27 Jul 2026

·www.businesswire.com

Sonesitatug vedotin demonstrated a statistically significant and highly clinically meaningful improvement in overall survival in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers

WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the CLARITY-Gastric01 global Phase III trial showed that sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) in 2nd and later-line Claudin 18.2-positive advanced gastric cancers versus investigator’s choice of therapy. The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2) expression on at least 25% of tumor cells at any staining intensity. The trial had dual primary endpoints of OS in 3rd and later-line treatment and progression-free survival (PFS) in the overall trial population. The trial met the dual primary endpoint of OS in 3rd and later-line treatment, and a key secondary endpoint of OS in the overall trial population of patients treated in the 2nd and later-line setting, demonstrating a statistically significant and highly clinically meaningful improvement. For the other dual primary endpoint of PFS as assessed by blinded independent central review (BICR), results showed a trend toward improved PFS in patients treated in the 2nd and later-line setting but did not reach statistical significance. The majority of patients with gastric/GEJ cancers are diagnosed at an advanced or metastatic stage, where the prognosis is especially poor and treatment options are limited, with less than 20% surviving more than one year.1,2 CLDN18.2 has emerged as an important therapeutic target for these patients, with an estimated 60% of gastric/GEJ cancers expressing CLDN18.2 in 25% or more of tumor cells.3 Each year, there are roughly 183,500 patients in the US, EU, China and Japan treated in the 2nd and later-line setting for advanced or metastatic CLDN18.2-positive, non-HER2-positive gastric/GEJ cancers.4 Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and principal investigator of the trial said: “Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, said: “Sone-Ve has the potential to reshape the treatment of gastric cancer by replacing classic chemotherapy with this novel targeted antibody drug conjugate to improve outcomes for patients. These transformative results from the first Phase III readout for Sone-Ve, together with our broad development program, highlight the potential for Sone-Ve to become an important new medicine in CLDN18.2-positive cancers.” Sone-Ve was well tolerated, and its profile was consistent with the known safety profile of Sone-Ve with no new safety signals identified. Sone-Ve is a potential global first-in-class CLDN18.2-targeting antibody drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Sone-Ve has received Orphan Drug Designation from the US Food and Drug Administration and the European Commission for the treatment of gastric and GEJ cancers. It has also received Breakthrough Designation in China for the 2nd-line treatment of gastric cancer. Notes Gastric and GEJ cancers Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-leading cause of cancer-related death.5 Nearly one million new patients were diagnosed with gastric cancer in 2024, with approximately 650,000 deaths reported globally. In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5 GEJ cancer is a type of gastric cancer that arises from and spans the area where the esophagus connects to the stomach.6 Most advanced gastric cancer patients will eventually experience disease progression after standard 1st-line therapies, and subsequent lines yield poor outcomes, with median survival of 5-9 months for patients receiving 2nd and later-line systemic treatments.7-9 CLARITY-Gastric01 CLARITY-Gastric01 is a randomized, open-label, sponsor-blinded, multicenter, global Phase III trial evaluating Sone-Ve as a 2nd and later-line therapy for patients with advanced or metastatic gastric cancer, GEJ cancer, or EAC with CLDN18.2 expression in 25% or more of tumor cells, with IHC+ of any intensity. In the trial, patients were randomized 1:1:1 in Stage 1 (dose selection) to Sone-Ve monotherapy 2.2 mg/kg or 1.8 mg/kg every three weeks, or investigator’s choice of therapy, the comparator arm. In Stage 2, the trial continued with Sone-Ve 2.2 mg/kg as the recommended Phase III dose. The efficacy analyses from this study will also provide the basis to evaluate the clinical performance of the Ventana SP455 assay for the identification of patients with advanced or metastatic gastric, GEJ or EAC cancers expressing CLDN18.2 who may benefit from Sone-Ve. The trial is being conducted in 175 centers across 19 countries, including in North America, Europe, South America and Asia. Its dual primary endpoints are PFS as assessed by BICR in the 2nd and later-line setting and OS in the 3rd and later-line setting. A key secondary endpoint is OS in the 2nd and later-line setting. Sonesitatug Vedotin (Sone-Ve) Sone-Ve is a novel ADC targeting CLDN18.2, a protein found in the stomach lining and a validated therapeutic target in oncology, particularly for GI cancers. Sone-Ve consists of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker and a cytotoxic small molecule MMAE payload. AstraZeneca entered into a global exclusive license agreement with KYM Biosciences to develop and commercialize Sone-Ve in March 2023. In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the CLARITY-Gastric02 Phase III trial in combination with capecitabine, with or without rilvegostomig, as a 1st-line treatment for advanced or metastatic gastric cancer, GEJ cancer and EAC. In Phase II development, Sone-Ve is being evaluated in patients with advanced solid tumors in multiple combinations across settings, including in CLDN18.2-positive pancreatic and biliary tract cancers (BTC). AstraZeneca in GI cancers AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2024, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.10 Within this program, the Company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic and colorectal cancers. Durvalumab, an anti-PDL1 antibody, is approved in the US, China, EU, Japan and other countries in combination with chemotherapy in locally advanced or metastatic BTC, in combination with tremelimumab-actl in unresectable hepatocellular carcinoma (HCC) and in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) in early-stage and locally advanced gastric and GEJ cancers. Durvalumab is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. Fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC is approved in the US, China, EU, Japan and several other countries for HER2-positive advanced gastric cancer. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Olaparib, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc., known as MSD outside the US and Canada. Savolitinib, an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI), has received conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or GEJ adenocarcinoma harboring MET amplification who have progressed on at least two prior lines of systemic therapy. Savolitinib is being jointly developed and commercialized by AstraZeneca and HUTCHMED. The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, and in combination with fam-trastuzumab deruxtecan-nxki in previously untreated, HER2-expressing, locally advanced or metastatic BTC. Rilvegostomig is also being evaluated in combination with bevacizumab with or without tremelimumab-actl as a 1st-line treatment in patients with advanced HCC, and as a 1st-line combination treatment in patients with HER2-positive, or CLDN18.2-positive and HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. In addition to Sone-Ve, AstraZeneca is also advancing AZD5863, a novel CLDN18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development. In early development, AstraZeneca is developing AZD7003, a Glypican 3 armored CAR T, in HCC. The Company is also advancing a pan-KRAS inhibitor program licensed from Jacobio Pharma, which is being evaluated in Phase I trials in advanced solid tumors with KRAS alterations, including in pancreatic ductal adenocarcinoma. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. References Davis JA, et al. Treatment heterogeneity and overall survival in patients with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma in the United States. J Gastrointest Oncol . 2022 Jun;13(3):949-957. Cancer Research UK. Survival for stomach cancer. https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival . Accessed July 2026. Poniewierska-Baran A, et al. Claudin18.2 as a Promising Therapeutic Target in Gastric Cancer. Cells. 2025;14(16):1285. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Top 8 Countries. Available at: https://www.astrazeneca.com/investor-relations.html . Accessed July 2026. World Health Organization. International Agency for Research on Cancer. Stomach Fact Sheet. Available at: https://gco.iarc.who.int/today/en/fact-sheets-cancers/7/stomach . Accessed July 2026. National Cancer Institute. Gastroesophageal junction. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction . Accessed July 2026. Abderhalden LA, et al. Clinical Outcomes for Previously Treated Patients with Advanced Gastric or Gastroesophageal Junction Cancer: A Systematic Literature Review and Meta-Analysis. J Gastrointest Cancer. 2023;54(4):1031-1045. Ford HE, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. ⁠ The Lancet Oncology , 2014;15(1), 78-86. Wilke H, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a randomised, multicentre, double-blind, phase 3 trial. ⁠ The Lancet Oncology , 2014;15(11), 1224-1235. World Health Organization. World Cancer Fact Sheet. Available at https://gco.iarc.who.int/today/en/fact-sheets-populations/900/world . Accessed July 2026. US- 114581 Last Updated 7/26

Phase 3Clinical ResultPhase 1License out/inDrug Approval

14 Jul 2026

·www.astrazeneca.com

AstraZeneca enters exclusive global license agreement for novel oral EGFR inhibitor Zegfrovy for lung cancer with Dizal Pharmaceutical

AstraZeneca has entered into an exclusive license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy. Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Approximately 80-85% of lung cancer patients globally have NSCLC. About 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR-mutated (EGFRm) NSCLC. Roughly one in four patients with EGFRm NSCLC has a tumour with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited. Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe.” Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: “As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China. Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion non-small cell lung cancer approved in the US and China for patients following prior systemic therapy.” Dizal recently announced positive results from the global WU-KONG28 Phase III trial of Zegfrovy in 1st-line NSCLC with exon 20 insertion EGFR mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. Supported by these results, a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting. Sunvozertinib (Zegfrovy) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines® for detailed recommendations.1 Financial considerations AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2026. Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.2 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.2-3 Approximately 75% of people are diagnosed with advanced NSCLC.4 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.5-7 Zegfrovy Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. In addition, Zegfrovy also demonstrated encouraging anti-tumour activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon 20 insertions. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related treatment-emergent adverse events were Grade 1/2 in nature and clinically manageable. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026). https://www.nccn.org/login?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 2026. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed August 2025. 3. American Cancer Society. What Is Lung Cancer?. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2025. 4. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. 5. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. 6. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. 7. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

Phase 3Drug ApprovalLicense out/inASCOBreakthrough Therapy

100 Deals associated with Savolitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11139	Savolitinib	L01XE	DB12048

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	China	Hutchison MediPharma Ltd.	30 Jun 2026
Stomach Cancer	China	Hutchison MediPharma Ltd.	30 Jun 2026
EGFR mutation MET positive Non-small Cell Lung Cancer	China	Hutchison MediPharma Ltd.	24 Jun 2025
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer	China	Hutchison MediPharma Ltd.	22 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
MET gene amplification Non-small Cell Lung Cancer	NDA/BLA	China	Hutchison MediPharma Ltd.	31 Dec 2024
Papillary Renal Cell Carcinoma	NDA/BLA	-	HUTCHMED (China) Ltd.	06 Jun 2022
c-Met positive Stomach Cancer	Phase 3	China	Hutchison MediPharma Ltd.	15 Jun 2026
HER2 positive Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Hutchison MediPharma Ltd.	15 Jun 2026
Carcinoma	Phase 3	United States	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Japan	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Austria	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Belgium	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Bulgaria	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Greece	AstraZeneca PLC	03 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03598244 (CTgov)	Phase 1	Refractory Central Nervous System Lymphoma \| Recurrent Medulloblastoma \| Refractory Medulloblastoma ... View more	41	X-Ray Imaging+Savolitinib	dxgkbnciwc = ysyhjtrxkf cslwcowsmw (yjcbospxsi, gphwsbtsps - twgoclzpuz) View more	-	23 Jun 2026
NCT04923932 (ASCO2026)	Phase 2	c-Met positive Stomach Cancer \| Gastroesophageal junction adenocarcinoma MET-amplified	65	Savolitinib 200 mg (BW < 50 kg) or 300 mg (BW ≥50 kg) BID (MET-amplified gastric cancer or gastroesophageal junction adenocarcinoma)	cuxymmgvkz(yqvbtfmlvf) = zcuiimrtcf bbjeoywlam (miztwajoos, 21.2 - 45.1) View more	Positive	29 May 2026
				Savolitinib 200 mg (BW < 50 kg) or 300 mg (BW ≥50 kg) BID (baseline ctDNA MET-positive)	cuxymmgvkz(yqvbtfmlvf) = nmdcwgnnug bbjeoywlam (miztwajoos, 29.8 - 61.3) View more
NCT05043090 \| NCT02819596 (CALYPSO, Pubmed \| J Clin Oncol)	Phase 2	Neoplasm Metastasis MET \| PD-L1 \| tumor mutational burden (TMB)	41	Savolitinib and Durvalumab	ucivkytlbs(xsfvccanpu) = ewfkoxthnw pedphqhmaa (uhggxydfxw, 7.3 - 30.7) View more	Positive	20 Apr 2026
				Savolitinib and Durvalumab (MET-driven patients)	ucivkytlbs(xsfvccanpu) = ozcogszjep pedphqhmaa (uhggxydfxw, 9.3 - 37.4) View more
NCT04923945 (Pubmed \| Lancet Reg Health West Pac)	Phase 3	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET exon 14-mutated	166	Savolitinib (Non-small cell lung cancer with MET exon 14 mutation + Treatment-naïve)	lkshwchwav(ynhguvfkji) = rndfsflpje obmvnzklgs (hcmrjelipk, 31 - 53) View more	Positive	01 Apr 2026
				Savolitinib (Non-small cell lung cancer with MET exon 14 mutation + Previously treated)	lkshwchwav(ynhguvfkji) = iuacuxudqc obmvnzklgs (hcmrjelipk, 51 - 72)
NCT03944772 (ORCHARD, Pubmed \| J Thorac Oncol)	Phase 2	EGFR mutation MET positive Non-small Cell Lung Cancer Second line EGFR-Mutated \| MET Alterations	32	Osimertinib plus Savolitinib	reswpxrbec(chskesktep) = leeeecjuhc zxjexuwvax (aemjilempu, 34 - 60) View more	Positive	01 Feb 2026
NCT05163249 (FLOWERS, Pubmed \| Nat Commun)	Phase 2	EGFR mutation MET positive Non-small Cell Lung Cancer First line EGFR mutations \| MET amplification or overexpression	44	Osimertinib 80 mg	lfxzzartwi(kxawqimuoi) = islktxcvxw yydshhtjjy (ulfadhzgvw, 38.5 - 80.3) View more	Positive	13 Jan 2026
				Osimertinib 80 mg + Savolitinib 300 mg	lfxzzartwi(kxawqimuoi) = ibclbxsgwk yydshhtjjy (ulfadhzgvw, 69.6 - 98.8) View more
NCT05015608 (SACHI, Pubmed \| Lancet \| Biospace) Manual	Phase 3	EGFR mutation MET positive Non-small Cell Lung Cancer MET Amplification \| EGFR Mutation	211	Savolitinib+osimertinib (ITT population)	iqqwzbifdp(gffmnzobam) = prifjhtfxz dmwohkelcf (jxkyhwdbtz ) Met View more	Positive	01 Jan 2026
				Chemotherapy (pemetrexed + cisplatin or carboplatin) (ITT population)	iqqwzbifdp(gffmnzobam) = pmuxwgbtbn dmwohkelcf (jxkyhwdbtz ) Met View more
NCT03778229 (SAVANNAH, Pubmed \| Clin Lung Cancer)	Phase 2	MET Amplified \| EGFR Mutated	30	Savolitinib 300 mg QD + Osimertinib 80 mg QD	amzrvqenqz(utqlvansbw) = zuxooophqy nbeyrbznzk (yjfpykfwvw, 29 - 82) View more	Positive	01 Jan 2026
				Savolitinib + Placebo	amzrvqenqz(utqlvansbw) = xdlsjlzydp nbeyrbznzk (yjfpykfwvw, 2 - 38) View more
NCT05015608 (SACHI, ESMO_ASIA2025)	Phase 3	Non-Small Cell Lung Cancer MET amplification	431	Savolitinib + Osimertinib	ebdjcxksqe(elaqranztk) = kkahabisbq svvtcqaxmw (yxwtrlnnwq ) View more	Positive	05 Dec 2025
				Chemotherapy	ebdjcxksqe(elaqranztk) = dxwuxfqgqp svvtcqaxmw (yxwtrlnnwq ) View more
NCT05015608 (SACHI, ESMO_ASIA2025)	Phase 3	Second line EGFR-mutant \| MET-amplified	256	Savo+Osi/Crossover	sjyzvipqgc(ejsqrlqtjl) = fmlyyxwmce qhsfabpmxh (gdlnnkxtbi ) View more	Positive	05 Dec 2025
				Pemetrexed+Platinum	sjyzvipqgc(ejsqrlqtjl) = ybfwfffoms qhsfabpmxh (gdlnnkxtbi ) View more

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