**Hutchmed Announces China NDA for Sovleplenib in Warm Autoimmune Hemolytic Anemia Accepted with Priority Review and Breakthrough Therapy Designation**

Hong Kong, Shanghai, and Florham Park, New JerseyApril 29, 2026 /PRNewswire/ — Hutchmed (China) Limited (“Hutchmed” or “HUTCHMED”) (Nasdaq/LSE: HCM; HKEX: 13) today announced that the New Drug Application (NDA) for sovleplenib for the treatment of adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) who have had an inadequate response to at least prior glucocorticoid therapy has been accepted by the China National Medical Products Administration (NMPA) and granted priority review. Sovleplenib is a novel, highly selective oral spleen tyrosine kinase (Syk) inhibitor being developed for the treatment of autoimmune diseases and hematological malignancies.

Data from the ESLIM-02 study support this NDA. The ESLIM-02 study is a randomized, double-blind, placebo-controlled Phase II/III clinical trial in China conducted in adult patients with primary or secondary warm antibody autoimmune hemolytic anemia who were relapsed or refractory after at least one prior standard treatment. In January 2026, the Phase III stage of the study met its primary endpoint of durable hemoglobin (Hb) response during weeks 5 to 24 of treatment. Phase III data from the study will be presented at the upcoming 2026 European Hematology Association (EHA) Annual Congress.

Mr. Simon To, Acting Chief Executive Officer and Chief Financial Officer of Hutchmed, said: “We are pleased to have submitted the NDA for sovleplenib for the treatment of warm antibody autoimmune hemolytic anemia and to have it granted priority review and breakthrough therapy designation by the NMPA. This is the second indication for which we have submitted an NDA for sovleplenib, further highlighting its broad potential as an innovative oral Syk inhibitor. We look forward to bringing this much-needed treatment option to patients with warm antibody autoimmune hemolytic anemia, who currently have limited therapeutic choices, while further strengthening our hematology portfolio through this important new indication.”

Sovleplenib was granted breakthrough therapy designation by the NMPA in March 2026 for the treatment of warm antibody autoimmune hemolytic anemia. The NMPA grants breakthrough therapy designation to innovative drugs intended for the prevention or treatment of serious diseases for which there are no effective prevention or treatment options, and that demonstrate clear clinical advantages over existing therapies.

About Sovleplenib and Warm Antibody Autoimmune Hemolytic Anemia

Sovleplenib is a novel, investigational selective oral small molecule Syk inhibitor. Syk, a key protein in the B-cell receptor and Fc receptor signaling pathways, is a well-established therapeutic target for various subtypes of B-cell lymphomas and autoimmune diseases.

Accelerated clearance of antibody-coated red blood cells by macrophages carrying immunoglobulin Fc-gamma receptors (FcγR) is considered the pathogenic mechanism of warm antibody autoimmune hemolytic anemia.^[6] Activated Syk mediates downstream signaling of activated Fc receptors in phagocytes, leading to phagocytosis of red blood cells.^[7] Additionally, activated Syk mediates the activation of B lymphocytes through the B-cell receptor and their differentiation into antibody-secreting plasma cells.^[8] Inhibiting Syk may offer therapeutic potential for warm antibody autoimmune hemolytic anemia by suppressing phagocytosis and reducing antibody production.

In addition to warm antibody autoimmune hemolytic anemia, studies of sovleplenib for the treatment of immune thrombocytopenia are also ongoing. Positive results from the ESLIM-01 Phase III study (NCT05029635) of sovleplenib in primary immune thrombocytopenia in China were published in The Lancet Haematology. The resubmitted NDA for the treatment of immune thrombocytopenia was accepted by the NMPA in February 2026 and granted priority review. According to IQVIA data, there are 41,000 new cases of immune thrombocytopenia annually in China, along with 430,000 existing patients. Approximately half of immune thrombocytopenia patients do not achieve optimal outcomes with currently approved therapies such as TPO (thrombopoietin)/TPO-RA (thrombopoietin receptor agonists).

Hutchmed currently retains all global rights to sovleplenib.

About Hutchmed

Hutchmed (Nasdaq/LSE: HCM; HKEX: 13) is a commercial-stage innovative biopharmaceutical company committed to the discovery, global development, and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immune diseases. Since its inception, Hutchmed has been dedicated to bringing its internally discovered drug candidates to patients worldwide. The first three drugs are now marketed in China, with the first also approved in the United States, Europe, Japan, and other global markets. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Hutchmed’s current expectations regarding future events, including expectations regarding the submission of the NDA for sovleplenib for the treatment of warm antibody autoimmune hemolytic anemia to the NMPA and the timing of such submission, the therapeutic potential of sovleplenib for patients with warm antibody autoimmune hemolytic anemia, and expectations regarding further clinical development plans for sovleplenib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include assumptions regarding: expectations regarding the timing and release of study results, the adequacy of data to support NDA submissions for sovleplenib for the treatment of warm antibody autoimmune hemolytic anemia or other indications in China or other regions, the potential for expedited regulatory approval or approval, the efficacy and safety of sovleplenib, Hutchmed’s ability to fund, achieve, and complete further clinical development plans and commercialization for sovleplenib, and the timing of such events. Current and potential investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. For further discussion of these and other risks, please refer to Hutchmed’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited, and AIM. Hutchmed undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances, or otherwise.

Medical Information

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