HUTCHMED (NASDAQ: HCM) reports Phase III wAIHA sovleplenib win
Rhea-AI Filing Summary
HUTCHMED (China) Limited reports that the Phase III registration part of its ESLIM-02 trial of sovleplenib in adults with warm antibody autoimmune hemolytic anemia (wAIHA) in China met its primary endpoint. The study achieved a durable hemoglobin response rate between weeks 5 and 24, indicating rapid and sustained improvements in red blood cell levels for relapsed or refractory patients.
Earlier Phase II data showed hemoglobin benefits versus placebo with overall response rates of 43.8% vs 0% in the first 8 weeks, and 66.7% over 24 weeks of sovleplenib treatment with a favorable safety profile. HUTCHMED plans to submit a New Drug Application for sovleplenib in wAIHA to China’s NMPA in the first half of 2026 and is also developing the drug for immune thrombocytopenia, where a China Phase III trial has already reported positive results.
Positive
- Phase III success in wAIHA: ESLIM-02’s Phase III registration part met its primary endpoint of durable hemoglobin response between weeks 5 and 24 in relapsed or refractory warm autoimmune hemolytic anemia.
- Strong supporting Phase II data: Phase II results showed overall response rates of 43.8% vs 0% at 8 weeks and 66.7% over 24 weeks of sovleplenib treatment with a favorable safety profile.
- Clear regulatory path in China: HUTCHMED plans to submit a New Drug Application for sovleplenib in wAIHA to the China NMPA in the first half of 2026, signaling an advanced development stage.
- Additional indication with positive data: Sovleplenib has already produced positive China Phase III results in primary immune thrombocytopenia, with an NDA resubmission planned in the first half of 2026.
Negative
- None.
Insights
Positive Phase III wAIHA data support HUTCHMED’s plan for a China NDA for sovleplenib.
The company discloses that the Phase III registration part of the ESLIM-02 trial of sovleplenib in adult warm antibody autoimmune hemolytic anemia met its primary endpoint of durable hemoglobin response between weeks 5 and 24. This comes on top of Phase II data showing overall response rates of
Investigators highlight wAIHA as a heterogeneous, often chronically relapsing, potentially life-threatening disease with limited options after standard therapies fail. Sovleplenib’s Syk inhibition is positioned to reduce antibody-mediated red blood cell destruction and antibody production, aligning its mechanism with disease biology. HUTCHMED states it plans to submit a New Drug Application for wAIHA in the first half of
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the Month of January 2026
Commission File Number: 001-37710
HUTCHMED (CHINA) LIMITED
(Translation of registrant’s name into English)
48th Floor, Cheung Kong Center, 2 Queen’s Road Central, Hong Kong
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ⌧ Form 40-F ◻
HUTCHMED (CHINA) LIMITED
Form 6-K
EXHIBIT INDEX
Exhibit No. | | Description |
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Exhibit 99.1 | | Press release relating to HUTCHMED announces positive topline results of phase III part of ESLIM-02 trial of sovleplenib for warm antibody autoimmune hemolytic anemia in China |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| HUTCHMED (CHINA) LIMITED | |
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| By: | /s/ Johnny Cheng |
| Name: | Johnny Cheng |
| Title: | Chief Financial Officer |
Date: January 7, 2026
3
Press Release
HUTCHMED Announces Positive Topline Results of Phase III Part of ESLIM-02 Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China
— Delivers rapid, durable responses in wAIHA, the more common form of this potentially life-threatening disease —
Hong Kong, Shanghai & Florham Park, NJ — Wednesday, January 7, 2026: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Phase III registration part of the ESLIM-02 clinical trial of sovleplenib, a novel spleen tyrosine kinase (“Syk”) inhibitor, in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China has met its primary endpoint of durable hemoglobin (Hb) response rate within weeks 5 to 24 of treatment.
Autoimmune hemolytic anemia (“AIHA”) is an autoimmune disorder characterized by the destruction of red blood cells (“RBCs”) due to the production of antibodies against RBC. The incidence of AIHA is estimated to be 0.8-3.0/100,000 adults per year with an estimated prevalence of 17 per 100,000 adults and a death rate of 8-11%.1,2 wAIHA is the most common form of AIHA,3 accounting for about 75-80% of all adult AIHA cases.4
ESLIM-02 is a randomized, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment. Results from the Phase II part of the study published in The Lancet Haematology in January 2025 demonstrated encouraging hemoglobin benefit compared with placebo, with overall response rate of 43.8% vs 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo) with a favorable safety profile.5 Additional details may be found at clinicaltrials.gov, using identifier NCT05535933.
Professor Fengkui Zhang of the Chinese Academy of Medical Sciences Blood Diseases Hospital, and one of the leading principal investigators of the ESLIM-02 study, said: “Warm antibody autoimmune hemolytic anemia is a highly heterogeneous and often chronically relapsing disease. Patients often experience symptoms like fatigue significantly impacting patients’ quality of life. In severe cases, the disease can become life-threatening if not managed effectively. The positive topline results from ESLIM-02 highlight sovleplenib's potential to deliver rapid and durable hemoglobin responses in wAIHA patients who have limited options after failing standard therapies. This could represent a meaningful advancement for managing this challenging condition.”
Professor Bin Han of Peking Union Medical College Hospital and Professor Lianshan Zhang of The Second Hospital of Lanzhou University were also co-leading Principal Investigators of the study. Full results of the ESLIM-02 study will be submitted for presentation at an upcoming scientific conference. HUTCHMED plans to submit the New Drug Application (“NDA”) for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026.
About Sovleplenib and wAIHA
Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor and Fc receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.
The accelerated clearance of antibody-coated RBCs by immunoglobulin Fc-gamma receptor (FcγR) bearing macrophages is thought to be the pathogenic mechanism in wAIHA.6 Activated Syk mediates downstream signaling of the activated Fc receptors in phagocytic cells, resulting in phagocytosis of RBCs.7 In addition, activation of Syk through the B-cell receptor mediates activation and differentiation of B-lymphocytes into antibody secreting plasma cells.8 Inhibition of Syk may have potential effects in the treatment of wAIHA through inhibition of phagocytosis and reduction of antibody production.
In addition to wAIHA, sovleplenib is also being studied in immune thrombocytopenia (“ITP”). Positive results from ESLIM-01 (NCT05029635), a Phase III trial in China of sovleplenib in patients with primary ITP, have been published in The Lancet Haematology. An NDA resubmission for sovleplenib for second-line ITP is planned in the first half of 2026.
HUTCHMED currently retains all rights to sovleplenib worldwide.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. 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 US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of sovleplenib for the treatment of wAIHA and the further development of sovleplenib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support a new drug application submission of sovleplenib for the treatment of wAIHA or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety profile of sovleplenib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for sovleplenib and the timing of these events. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on 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
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
CONTACTS
Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
Media Enquiries | |
FTI Consulting – | +44 20 3727 1030 / HUTCHMED@fticonsulting.com |
Ben Atwell / Tim Stamper | +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile) |
Brunswick – Zhou Yi | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
Panmure Liberum | Nominated Advisor and Joint Broker |
Atholl Tweedie / Emma Earl / Rupert Dearden | +44 20 7886 2500 |
Cavendish | Joint Broker |
Geoff Nash / Nigel Birks | +44 20 7220 0500 |
Deutsche Numis | Joint Broker |
Freddie Barnfield / Jeffrey Wong / Duncan Monteith | +44 20 7260 1000 |
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REFERENCES
1 | Eaton WW, Rose NR, Kalaydjian A, Pedersen MG, Mortensen PB. Epidemiology of autoimmune diseases in Denmark. J Autoimmun. 2007; 29 (1):1-9. doi: 10.1016/j.jaut.2007.05.002. |
2 | Roumier M, Loustau V, Guillaud C, et al. Characteristics and outcome of warm autoimmune hemolytic anemia in adults: new insights based on a single-center experience with 60 patients. Am J Hematol. 2014; 89 (9):E150-5. doi: 10.1002/ajh.23767. |
3 | Cotran Ramzi S, Kumar Vinay, Fausto Nelson, Nelso Fausto, Robbins Stanley L, Abbas Abul K. Robbins and Cotran pathologic basis of disease. St. Louis, Mo: Elsevier Saunders; 2005. p. 637. |
4 | Gehrs BC, Friedberg RC. Autoimmune haemolytic anemia. Am J Hematol. 2002; 69:258–271. doi: 10.1002/ajh.10062. |
5 | Zhao X, Sun J, Zhang Z, et al. Sovleplenib in patients with primary or secondary warm autoimmune haemolytic anaemia: results from phase 2 of a randomised, double-blind, placebo-controlled, phase 2/3 study. Lancet Haematol. 2025;12(2):e97-e108. doi:10.1016/S2352-3026(24)00344-2 |
6 | Barros MM, Blajchman MA, Bordin JO. Warm autoimmune hemolytic anemia: recent progress in understanding the immunobiology and the treatment. Transfus Med Rev. 2010; 24(3):195‐210. doi: 10.1016/j.tmrv.2010.03.002. |
7 | Barcellini W, Fattizzo B, Zaninoni A. Current and emerging treatment options for autoimmune hemolytic anemia. Expert Rev Clin Immunol. 2018; 14(10):857‐872. doi: 10.1080/1744666x.2018.1521722. |
8 | Davidzohn N, Biram A, Stoler‐Barak L, Grenov A, Dassa B, Shulman Z. SYK degradation restrains plasma cell formation and promotes zonal transitions in germinal centers. J Exp Med. 2020; 217(3):e20191043. doi: 10.1084/jem.20191043. |
FAQ
What did HUTCHMED (HCM) announce about the ESLIM-02 trial in wAIHA?
What earlier Phase II results support sovleplenib in wAIHA for HCM?
When does HUTCHMED plan to file an NDA for sovleplenib in wAIHA?
What is sovleplenib and how does it work in autoimmune diseases?
Besides wAIHA, what other indication is HUTCHMED pursuing with sovleplenib?
Does HUTCHMED hold global rights to sovleplenib?
