Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 160

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 160
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 degranulation to release immune active substances, leading to immunological reaction and disease. Regulating B-cell signal pathways through Syk is expected to be effective for treating lymphoma.

Sovleplenib Regulatory Status and Path

We submitted the NDA for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ ITP”), and the it was accepted by the NMPA in January 2024 with priority review status. This NDA is supported by data from ESLIM-01, a China Phase III randomized, double-blinded, placebo-controlled study of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. In January 2022, sovleplenib received the Breakthrough Therapy Designation in China for treatment of primary ITP. In 2024, we started a Phase I/Ib dose-optimization study overseas (NCT06291415).

Table of Contents

Besides the clinical trials related to primary ITP, we also have various clinical trials of sovleplenib ongoing. In September 2022, we initiated ESLIM-02, a China Phase II/III randomized, double-blind, placebo-controlled study of sovleplenib in the treatment of wAIHA. The enrollment of Phase II part of the study was completed in mid-2023 and primary end point has been met. We initiated the Phase III phase in March 2024 in China.

Sovleplenib Pre-clinical Evidence

The safety profile of sovleplenib was evaluated in multiple in vitro and in vivo pre-clinical trials under good laboratory practice guidelines and found to be well tolerated following single dose oral administration. It is a highly selective Syk inhibitor with an IC50 of 24 ± 4 nM in a Syk kinase enzymatic assay. Sovleplenib’ s lack of KDR inhibition means a much lower risk of hypertension, a major off-target toxicity in clinical trials. Sovleplenib was evaluated in collagen-induced rheumatoid arthritis in mice and rats and it significantly reduced disease severity in a dose dependent manner; stopping disease progression, and reversing paw swelling and bone resorption to normal levels. In lupus-prone mice, sovleplenib significantly blocked skin lesions, delaying the onset of proteinuria, reducing the immune organs to body weight ratios and suppressing the production of anti-nuclear antibodies.

Sovleplenib Clinical Development