Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 181

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 181
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 2 (2x)          6.4 (9x)  
  PI3K α (fold vs. PI3K δ)            >1,000 (>1,250x)      866 (433x)      143 (143x)      0.5 (1x)  
  PI3K δ human whole blood CD63+      3                     14              15              n/a       
  PI3K β (fold vs. PI3K δ)            87 (109x)             293 (147x)      8 (8x)          3.7 (5x)  

  Treatment        Patient Focus             Sites      Phase                Status/Plan                                                                 NCT #        
  Amdizalisib      3L r/r FL 2L r/r MZL      China      II Registration      Met primary endpoint in r/r FL cohort Breakthrough Therapy Designation      NCT04849351  
  Amdizalisib      Indolent NHL PTCL         China      Ib                   Completed Data presented at ICML 2023                                       NCT03128164  
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Phase II registration-intent study of amdizalisib in r/r FL and r/r MZL (NCT04849351)

In April 2021, we commenced a China Phase II single-arm, open-label, registration-intent study in 108 patients with r/r FL and approximately 80 patients with r/r MZL. In February 2023, the trial has fully enrolled the FL cohort and the primary endpoint of ORR met its pre-specified threshold.

Phase Ib study of amdizalisib in indolent NHL (NCT03128164)

Our China Phase I/Ib open-label study in r/r NHL successfully established a Phase II dose and expanded into multiple sub-categories of indolent NHL. Updated safety data as well as efficacy data were reported at the International Conference on Malignant Lymphoma (“ ICML”) in June 2023. At median follow-up of 22.1 months, median DoR and PFS were not reached for the 26 efficacy evaluable patients in the follicular lymphoma cohort. For the MZL cohort of 16 efficacy evaluable patients, at median follow-up of 20.3 months, median DoR was not reached and median PFS was 26