RCS - Hutchmed China Ltd - HUTCHMED Announces NDA Acceptance in China

HUTCHMED (China)Announcement

29/04/2026 11:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260429:nRSc4180Ca&default-theme=true

RNS Number : 4180C  Hutchmed (China) Limited  29 April 2026

Press Release

 

HUTCHMED Announces NDA Acceptance in China with Priority Review Status and Breakthrough Designation for Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Hong Kong, Shanghai & Florham Park, NJ -  Wednesday, April 29, 2026:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces 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 insufficient
response to at least one previous glucocorticoid treatment has been accepted
for review and granted priority review by the China National Medical Products
Administration ("NMPA"). Sovleplenib is a novel, selective, oral inhibitor
targeting spleen tyrosine kinase ("Syk"), being developed for the treatment of
immune diseases and hematological malignancies.

 

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 

 

The NDA is supported by data from ESLIM-02, 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. In January 2026, the Phase III
(https://www.hutch-med.com/sovleplenib-eslim-02-waiha-topline/) part of the
trial met its primary endpoint of durable hemoglobin (Hb) response rate within
weeks 5 to 24 of treatment. The Phase III results will be presented at the
upcoming European Hematology Association (EHA) Congress 2026.

 

Results from the Phase II part of the study published in
(https://pubmed.ncbi.nlm.nih.gov/39799953/) 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  Additional details of
the study may be found at clinicaltrials.gov, using identifier NCT05535933
(https://clinicaltrials.gov/ct2/show/NCT05535933) .

 

Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of
HUTCHMED, said, "We are pleased to have submitted the NDA for sovleplenib in
wAIHA, securing both Priority Review and Breakthrough Therapy Designation from
the NMPA. This marks the second indication for which we have submitted an NDA
for sovleplenib and underscores its broad potential as a novel oral Syk
inhibitor. We look forward to providing this much-needed option for wAIHA
patients with few treatment alternatives, while strengthening our hematology
portfolio with this valuable new indication."

 

The NMPA granted Breakthrough Therapy Designation to sovleplenib for the
treatment of wAIHA in March 2026, as a potential new treatment for a serious
condition for which there are no effective treatment options, and where
clinical evidence demonstrates significant advantages over existing therapies.

 

About Sovleplenib and wAIHA

Sovleplenib is a novel, investigational, selective small molecule inhibitor
for oral administration targeting 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
(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/) .
The NMPA accepted for review the resubmitted NDA filing for the treatment of
ITP and granted it priority review in February 2026. According to IQVIA, China
has 430,000 existing patients with 41,000 new ITP patients each year. About
half of ITP patients fail to have satisfactory results from currently approved
treatments such as TPO (thrombopoietin) /TPO-RAs (thrombopoietin receptor
agonists).

 

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
review of a NDA for sovleplenib for the treatment of wAIHA with the NMPA and
the timing of such review, 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 NDA approval 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 7779 436 698 (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    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.

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAILMLTMTTTMAF



            Copyright 2019 Regulatory News Service, all rights reserved