Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 117

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 117
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 2L METex14 skipping NSCLC and expanded the label to include 1L METex14 skipping NSCLC. In China, there are over 1 million new cases of lung cancer every year, with 80-85% classified as NSCLC, of which, approximately 2-3% have tumors with METex14 skipping alterations.

We are developing the next indication of savolitinib in combination with Tagrisso in 2L EGFRm NSCLC with MET amplification, currently under review by NMPA with Breakthrough Therapy designation and Priority Review Status. A similar combination Phase III study is underway globally by our partner AstraZeneca. Globally, there are about 2.4 million people diagnosed with lung cancer every year, with 80-85% classified as NSCLC. About 10-15% of NSCLC patients in the U. S. and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. While EGFR-targeted therapy can provide a substantial survival benefit to patients with EGFRm NSCLC, most will eventually develop resistance to their treatment, with MET being a common resistance biomarker. Among patients screened for enrollment in a Phase II study (SAVANNAH), an estimated 62% had tumors with MET overexpression and/or amplification, and approximately 34% met the defined high MET level cut-off upon clinical progression.

For savolitinib in combination with Tagrisso in 1L EGFRm NSCLC with MET overexpression, we are enrolling patients in a China Phase III study (SAVNOVO). Savolitinib has also completed recruitment of a global Phase III study in MET-driven PRCC (SAMETA) and continues to enroll patients in a China Phase II registration-intent study in 3L GC with MET amplification.

In 2011, following the discovery and initial development of savolitinib by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. The revenue we generate from savolitinib comprised of royalty revenue and manufacturing revenue of Orpathys, which we source from a third-party manufacturer and sell to AstraZeneca at cost. In 2024, savolitinib in-market sales were $45.1