Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 374

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 374
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 million in the sales of Fruzaqla outside of China in October 2024; (3) $5 million following the pricing approval and launch of Fruzaqla in Japan in November 2024 and (4) $10 million for receiving national reimbursement recommendation in Spain in December 2024, the first national reimbursement recommendation in Europe.
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Savolitinib (Orpathys in China)
Savolitinib was conditionally approved for 2L METex14 skipping NSCLC in China in June 2021, making it the first-in-class selective MET inhibitor in China. In January 2025, we received NMPA full approval of 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