Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 418

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 418
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L+ITP               China       III          NDA accepted in Jan 2024         NCT05029635
                                                                           Data at EHA 2024, ASH 2024                  
Sovleplenib   ​   ≥2L ITP                         U.S.        Ib           Started in 2024                  NCT06291415
Sovleplenib   ​   ESLIM-02: wAIHA                 China       II/III       Phase II data at EHA2024         NCT05535933
                                                                           Phase III since March 2024                  
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Sovleplenib Monotherapy - ITP
ESLIM-01: Phase III study of sovleplenib in ITP (NCT05029635)
ESLIM-01 is a China Phase III randomized, double-blinded, placebo-controlled study in patients with primary ITP who have received at least one prior line of standard therapy. Between Sept 29, 2021, and Dec 31, 2022, 188 patients were 2:1 randomized to receive sovleplenib 300 mg OD or placebo for 24 weeks. Primary endpoint is durable response rate. In January 2022, the NMPA granted Breakthrough Therapy Designation for this indication. All endpoints were met in August 2023. In June 2024, we presented the results at EHA 2024 and published in The Lancet Haematology. Long-term follow-up analysis was presented at ASH 2024. The NDA is under review by the NMPA. Additional data were requested by CDE and subsequently submitted by HUTCHMED. The supplementary data is currently under review by CDE.
Durable response rate (platelet count ≥50x109/L in 4 or more of the 6 visits during 12–24 weeks) was 48.4% with sovleplenib compared to zero with placebo (p<0.0001), which was consistent across most pre-defined subgroups. Overall response rates (platelet count ≥50x109/L at least once 0–24 weeks) were 68.3% at 0–12 weeks and 70.6% at 0–24 weeks with sovleplenib, compared to 14.5% and 16.1% with placebo (p<0.0001). The median time to response was 8 days with sovleplenib compared to