Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 161

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 161
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 Treatment        Trial Name, Patient Focus      Sites      Phase       Status/Plan                     NCT #        
  Sovleplenib      ESLIM-01: ≥ 2L+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 inThe 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%