RCS - Hutchmed China Ltd - Positive Topline Results of Phase III Trial

HUTCHMED (China)Announcement

07/01/2026 07:00

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RNS Number : 8735N  Hutchmed (China) Limited  07 January 2026

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 (https://www.hutch-med.com/) ")
(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  (#_edn1) (, 2  (#_edn2) ) wAIHA is the
most common form of AIHA, 3  (#_edn3) accounting for about 75-80% of all adult
AIHA cases. 4  (#_edn4)

 

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
(https://pubmed.ncbi.nlm.nih.gov/39799953/) 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  (#_edn5) Additional
details may be found at clinicaltrials.gov, using identifier NCT05535933
(https://clinicaltrials.gov/ct2/show/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
Liansheng 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  (#_edn6) Activated Syk mediates downstream signaling of the
activated Fc receptors in phagocytic cells, resulting in phagocytosis of
RBCs. 7  (#_edn7) In addition, activation of Syk through the B-cell receptor
mediates activation and differentiation of B-lymphocytes into antibody
secreting plasma cells. 8  (#_edn8) 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
(https://www.hutch-med.com/sovleplenib-eslim-01-in-the-lancet-haematology/)
The Lancet Haematology
(https://www.hutch-med.com/sovleplenib-eslim-01-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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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 (mailto:ir@hutch-med.com)

 Media Enquiries
 FTI Consulting -                                    +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                     (mailto: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
                                                     (mailto: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

 

 1  (#_ednref1)     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  (#_ednref2)     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  (#_ednref3)     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  (#_ednref4)     Gehrs BC, Friedberg RC. Autoimmune haemolytic anemia.
Am J Hematol. 2002; 69:258-271. doi: 10.1002/ajh.10062.

 5  (#_ednref5)     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  (#_ednref6)     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  (#_ednref7)     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  (#_ednref8)     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.

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