HUTCHMED Announces Positive Topline Results of Phase III Part of ESLIM-02 Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China
Rhea-AI Summary
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced that the Phase III registration part of the ESLIM-02 trial of sovleplenib, a Syk inhibitor for adult warm antibody autoimmune hemolytic anemia (wAIHA) in China, met its primary endpoint of durable hemoglobin response during weeks 5–24.
The randomized, double‑blind, placebo‑controlled study enrolled patients with primary or secondary wAIHA who relapsed or were refractory to ≥1 prior standard therapy. Earlier Phase II data reported overall response 43.8% vs 0% at 8 weeks and 66.7% at 24 weeks for sovleplenib with a favourable safety profile. HUTCHMED plans to submit a NDA to NMPA in H1 2026. Full ESLIM-02 results will be presented at an upcoming scientific conference.
Positive
- Phase III primary endpoint met: durable Hb response weeks 5–24
- Phase II efficacy: ORR 43.8% vs 0% at 8 weeks; 66.7% at 24 weeks
- NDA planned submission to NMPA in H1 2026
Negative
- None.
News Market Reaction – HCM
In the Jan 7 session, HCM gained 6.62%, reflecting a notable positive market reaction. Argus tracked a peak move of +3.6% during that session. Argus tracked a trough of -2.8% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. Trading volume was very high at 3.1x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| 2026-01-04 | Pancreatic trial update | Positive | -2.0% | Initiation of Phase III stage for S+C+AG in pancreatic cancer. |
| 2025-12-30 | NDA acceptance | Positive | -1.5% | China NMPA acceptance and priority review for savolitinib NDA. |
| 2025-12-29 | NDA acceptance | Positive | -2.7% | Fanregratinib NDA accepted with priority review for ICC in China. |
| 2025-12-16 | New trial initiation | Positive | +0.5% | Global Phase I/IIa launch of HMPL-A251 in HER2-expressing tumors. |
| 2025-12-07 | Reimbursement update | Positive | -1.3% | NRDL renewal and inclusion on China commercial insurance drug list. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent HUTCHMED news, including positive clinical and regulatory updates, has often been followed by modestly negative price reactions, indicating a tendency toward selling into good news.
Over the past months, HUTCHMED has reported several clinical and regulatory milestones. These include initiation of a Phase III pancreatic cancer trial on Dec 30, 2025, multiple NDA acceptances with priority review for savolitinib and fanregratinib in late Dec 2025, global Phase I/IIa development of HMPL-A251 starting Dec 16, 2025, and expanded reimbursement coverage effective Jan 1, 2026. Despite generally constructive news, share reactions around these events were often flat to negative, providing context for how investors have historically received pipeline progress.
Key Terms
spleen tyrosine kinase medical
autoimmune hemolytic anemia medical
warm antibody autoimmune hemolytic anemia medical
overall response rate medical
New Drug Application regulatory
National Medical Products Administration regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
— Delivers rapid, durable responses in wAIHA, the more common form of this potentially life-threatening disease —
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 07, 2026 (GLOBE NEWSWIRE) -- 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
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
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.
