Hutchmed's Candidate Achieves Main Goal In China's Rare Blood Disorder Study

HUTCHMED (China) Limited's (NASDAQ: ​HCM) pivotal Phase 3 trial ESLIM-01 evaluating the investigational use of sovleplenib met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia (ITP) in China. 

ITP is an autoimmune disorder characterized by immunologic destruction of platelets and decreased platelet production. Patients with ITP are at increased risk of excessive bleeding and bruising.

HUTCHMED plans to submit the New Drug Application (NDA) around the end of 2023.

The National Medical Products Administration of China (NMPA) granted Breakthrough Therapy designation to sovleplenib for the indication studied in ESLIM-01 in January 2022. 

As such, the sovleplenib NDA may be considered for priority review for its use in ITP.

The trial enrolled 188 adult patients with primary ITP who have received at least one prior line of standard therapy. 

The trial met its primary endpoint of demonstrating a clinically meaningful and statistically significant increase in durable response rate in patients treated with sovleplenib compared to patients treated with placebo. 

Secondary endpoints, including response rate and safety were also met. 

Full results will be submitted for presentation at an upcoming scientific conference.

Results from the Phase I/II study in China published in The Lancet Haematology showed a rapid and durable increase in platelet counts in previously treated patients with ITP. 

Among the 20 patients who received the recommended Phase II dose of 300mg once daily (RP2D), 8 (40%) patients experienced durable responses in four out of six visits during weeks 14 to 24 of the study. 

HUTCHMED currently retains all rights to sovleplenib worldwide. In addition to ITP, sovleplenib is also being studied in warm antibody autoimmune hemolytic anemia and indolent non-Hodgkin's lymphoma.

Price Action: HCM shares are up 3.25% at $13.65 on the last check Monday.

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