Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 431

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 431
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 CLL, SLL, other B-NHL   ​   China   ​   I       ​   Dose expansion arm ongoing   ​   NCT05190068
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Phase II study of HMPL-760 in patients with r/r DLBCL (NCT06601504)
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In November 2024, we started China Phase II randomized, active-controlled study of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with r/r DLBCL.
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Phase I study of HMPL-760 in patients with r/r lymphomas (NCT05190068)
In this dose escalation phase, patients with r/r lymphoma that failed standard therapy were eligible. Data was presented at EHA Congress in June 2024. As of September 30, 2023, a total of 26 patients with r/r lymphoma (10 CLL/SLL, 4 MCL, 7 DLBCL, 2 LPL/WM, 2 FL, 1MZL) were treated. The median number of prior therapies was 2, of which 8 patients had prior exposure to BTK inhibitors. No DLT was observed in dose-escalation phase and maximum tolerated dose was not reached up to 600 mg. The most common (≥30%) TRAEs were neutrophil count decrease, platelet count decrease, and anaemia. Most of the TRAEs were concentrated in grade 1-2. Only 2 patients (600 mg) experienced drug-related serious adverse events (pulmonary tuberculosis, drug-induced liver injury). 26 patients had post-baseline tumor assessment and achieved ORR of 73.1%. The median TTR was 2.3 months. Among 8 patients treated with BTK inhibitors, the ORR was 87.5%. 400 mg OD was selected as RP2D.
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9. HMPL-506
HMPL-506 is a novel, investigational, selective small molecule inhibitor for oral administration targeting the menin protein. The menin protein is a scaffold protein that controls gene expression and cell signaling. Revumenib is the only FDA approved menin inhibitor and currently there is no menin inhibitors approved in China. We retain all rights to HMPL-506 worldwide.
HMPL-506 Mechanism of Action
Mixed-lineage leukemia (“MLL”, also known as KMT2A) rearrangement and nucleophosmin