Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 163

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 163
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 being≥50×109/L in the initial 8-week double blinded phase of the study. In total, 80% experienced response during both phases of the study. Durable response, defined as platelet count being≥50×109/L in at least 4 out of 6 last scheduled visits, were reported in 40% for those who received RP2D in both phases of the study.

Safety data were presented for all 41 patients who received treatment at all doses, regardless of whether they were initially randomized to receive active treatment or crossed over during the open-label extension phase of the study. No patients discontinued treatment due to treatment-related adverse events, and no cases of treatment-related serious adverse events were reported. There were 30 patients (73%) who experienced treatment-related adverse events, including 3 (7.3%) who experienced Grade≥3 TRAEs. No TRAE of Grade≥3 occurred in more than one patient.

Results of ESLIM-1 at EHA 2024 and ASCO 2024: durable response and long-term durable response

Table of Contents

Sovleplenib Monotherapy - wAIHA

ESLIM-02: Phase II/III study of sovleplenib for wAIHA (NCT05535933)

ESLIM-02 is a China Phase II/III randomized, double blind, placebo-controlled study in adult patients with primary or secondary AIHA who had relapsed or were refractory to at least one prior line of standard treatment. AIHA is an autoimmune disorder resulting in a shortened red blood cell (“ RBC”) life span and increased RBC clearance. Incidence ranges from 0.8 to 3.0 per 100,000/year globally, with a prevalence of 17 per 100,000. Mortality rates are 8 - 11% and up to 30% in severe cases involving critically ill patients. wAIHA is the most common form of AIHA and accounts for 70 - 80% of cases.

Between September 26, 2022 and May 9, 2023, 21 patients were enrolled in the Phase II part of the study and were randomized 3:1 to receive sovleplenib 300mg OD or placebo. Results were presented at EHA 2024 and published in The Lancet Haematology in February 2025. The overall Hb response rate (≥100g/L at least once and increase of�