Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 438

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 438
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‑689          Zydelig         Copiktra        Aliqopa
PI3Kδ                                          0.8 (n = 3)   2                1                0.7         
PI3Kγ (fold vs. PI3Kδ)                          114 (142x)        104 (52x)           2 (2x)       6.4 (9x)
PI3Kα (fold vs. PI3Kδ)              &gt;1,000 (&gt;1,250x)       866 (433x)       143 (143x)       0.5 (1x)
PI3Kδ human whole blood CD63+   3                                                                       n/a
PI3Kβ (fold vs. PI3Kδ)                           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
​
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