Regulatory Filings Accepted for Review

HUTCHMED Announces Regulatory Filings Accepted for Review for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung Cancer in Europe and Japan

• Follows US FDA new drug application submission in September 2026, marking important global regulatory progress -

Filings supported by positive SAFFRON global Phase III data demonstrating statistically significant and clinically meaningful PFS and OS improvements -

• Data selected for ESMO 2026 Presidential Symposium and simultaneously published in The New England Journal of Medicine -

Hong Kong, Shanghai & Florham Park, NJ - Monday, November 2, 2026: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:13) today announces that regulatory filings for ORPATHYS® (savolitinib) in combination with TAGRISSO® (osimertinib) have been accepted for review in Europe and Japan.

In Europe, the European Medicines Agency (EMA) has validated and accepted for regulatory review the Marketing Authorization Application (MAA) submitted by AstraZeneca, seeking approval for the combination for the treatment of patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") whose tumors have MET overexpression or amplification, and who had disease progression on or after an epidermal growth factor receptor ("EGFR") tyrosine kinase inhibitor ("TKI") therapy.

In Japan, AstraZeneca has submitted a New Drug Application ("NDA") to the Ministry of Health, Labour and Welfare (MHLW), which has also been accepted for review, seeking approval in patients with unresectable, advanced or recurrent NSCLC whose tumors have MET overexpression or amplification, and who had disease progression following EGFR-TKI therapy.

These filings in Europe and Japan follow the submission of an NDA for the same combination to the US Food and Drug Administration (FDA) in September 2026, marking further progress in expanding global access to this innovative targeted combination therapy.

The regulatory filings are supported by positive results from the SAFFRON global Phase III trial. These results have been presented in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 and simultaneously published in The New England Journal of Medicine.

ORPATHYS® plus TAGRISSO® 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 who progressed on treatment with TAGRISSO®. 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. 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). The safety profile was consistent with the known profiles of each medicine, and there were no new safety concerns.

Third-generation EGFR-TKIs have significantly improved outcomes for patients with EGFRm NSCLC. However, MET overexpression or amplification is one of the most common mechanisms of resistance on third-generation EGFR-TKI treatment. MET-driven progression is associated with poor prognosis, and there remains a significant unmet need for effective and well-tolerated treatment options in this setting.

ORPATHYS® is being jointly developed by AstraZeneca and HUTCHMED and is 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.[1],[2] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.[3] Approximately 75% of NSCLC patients are diagnosed with advanced disease.[4] Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.​[5]

MET is a tyrosine kinase receptor that has an essential role in normal cell development.[6] MET overexpression or amplification can lead to tumor growth and the metastatic progression of cancer cells.6,[7] 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.[8]

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.

About ORPATHYS®

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®

Medical Information

[1] 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.

[2] 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] 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] 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.