Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 127

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 127
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,000 nM, thousands of times higher than the IC50 on MET tumor cells.

The data above suggest that (i) savolitinib has potent activity against tumor cell lines with MET amplification in the absence of hepatocyte growth factor, or HGF, indicating that there is HGF-independent MET activation; (ii) savolitinib has potent activity in tumor cell lines with MET overexpressed, but only in the presence of HGF, indicating HGF-dependent MET activation; and (iii) savolitinib has no activity in tumor cell lines with low MET overexpression/ amplification, suggesting that strong kinase selectivity.

Savolitinib Clinical Development

Savolitinib Combination - Non-small Cell Lung Cancer

  Treatment                   Trial Name, Patient Focus                  Sites       Phase      Status/Plan                                 NCT #        
  Savolitinib + Tagrisso      SAVANNAH: 2L/3L EGFRm MET-                 Global      II         Fully enrolled in Feb 2024                  NCT03778229  
  Savolitinib + Tagrisso      SAFFRON: 2L/3L EGFRm MET-                  Global      III        Ongoing                                     NCT05261399  
  Savolitinib + Tagrisso      SACHI: 2L EGFRm MET-amplified post         China       III        Interim analysis met primary endpoint       NCT05015608  
                              1 st /2 nd /3 rd -generation EGFR-TKI                             NDA accepted in December 2024                            
  Savolitinib + Tagrisso      SANOVO: 1L EGFRm MET-overexpressed         China       III        Ongoing                                     NCT05009836  
  Savolitinib                 2L METex14 skipping alterations            China       II         NMPA approved                               NCT02897479  
  Savolitinib                 1/2L METex14 skipping alterations          China       IIIb       NMPA approved                               NCT04923945  
 ─────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────
                              amplified/overexpressed post Tagrisso                             Positive results announced in Oct 2024                   
                              amplified/overexpressed post Tagrisso                             Target recruitment completion 2H 2025                    

Table of Contents

In 2015, AstraZeneca received FDA approval for Tagrisso,