An Open-Label, Randomized, Three-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food on the Pharmacokinetics of HMPL-523 Acetate Tablets in Healthy Participants

This is a single-center, open-label, randomized, three-period, six-sequence study to evaluate the effect of food (high-fat and low-fat) on the PK of HMPL-523. In this study, 18 healthy Chinese participants are planned to be enrolled, randomized in a ratio of 1:1:1:1:1:1 to one of 6 dosing sequences (see dosing sequence table for details), and administered once per cycle for 3 cycles, with a washout period of at least 7 days. The study consists of a screening/baseline period, a dosing period (three cycles), and a follow-up period.

Start Date10 Dec 2025

Sponsor / Collaborator

HUTCHMED (China) Ltd.

NCT07331194

/ RecruitingPhase 1

A Single-Center, Open-Label, Randomized, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of Two Different Formulations of HMPL-523 Acetate Tablets in Chinese Healthy Participants

Two formulations containing the same active pharmaceutical ingredient are considered bioequivalent if their relative bioavailability (rate and extent of drug absorption) falls within acceptable predetermined limits after administration at the same molar dose. Formulations with bioequivalence are considered to act comparably in vivo, i.e., similar in terms of safety and efficacy.
This study aims to evaluate the pharmacokinetic (PK) profile and bioequivalence of the original and modified formulations of HMPL-523 acetate tablets in healthy participants to bridge the safety and efficacy of the modified formulation of HMPL 523 acetate tablets in humans.

Start Date28 Oct 2025

Sponsor / Collaborator

HUTCHMED (China) Ltd.

NCT06291415

/ WithdrawnPhase 1

A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

Start Date02 Apr 2024

Sponsor / Collaborator

HUTCHMED (China) Ltd.

100 Clinical Results associated with Sovleplenib

100 Translational Medicine associated with Sovleplenib

100 Patents (Medical) associated with Sovleplenib

Literatures (Medical) associated with Sovleplenib

05 Dec 2025·Hematology-American Society of Hematology Education Program

Management of autoimmune hemolytic anemia

Review

Author: Fattizzo, Bruno ; Barcellini, Wilma

Abstract:

Autoimmune hemolytic anemia (AIHA) is caused by premature erythrocyte destruction mediated by autoantibodies (auto-Ab) with or without complement activation. The most frequent form (60%-70% of cases) is warm AIHA (wAIHA), driven by immunoglobulin G auto-Ab that react at body temperature. Cold agglutinin disease (CAD, 20%-25%) is the second most common form and is caused by immunoglobulin M auto-Ab that usually react at temperatures <20°C and strongly activate complement. Rarer forms (5%-10%) include mixed AIHAs (wAIHA plus CAD), and paroxysmal cold hemoglobinuria. Here, we present the management of wAIHA, as CAD is discussed separately. Approximately 50% of wAIHA are primary, whereas the remainder are secondary to various conditions (infections, lymphoproliferative disorders, systemic or organ-specific autoimmune diseases, congenital immunodeficiencies, hematopoietic stem-cell transplantation, and several drugs, including immune checkpoint inhibitors). The disease is highly heterogeneous, ranging from fully compensated to life-threatening, and frequently has a relapsing course. Standard first-line therapy includes steroids with or without intravenous immunoglobulin, transfusions when anemia is clinically significant, prophylactic anticoagulation for severe hemolysis, and recombinant erythropoietin when reticulocytopenia/inadequate bone marrow compensation is present. For severe cases, high-dose steroids and plasma-exchange may be considered. Rituximab is now the preferred second-line option for relapsed/refractory patients, comparing favorably with the traditional splenectomy. The latter is increasingly reserved for later lines together with classic immunosuppressants. Several novel treatments are in development for refractory wAIHA, encompassing drugs targeting B-cells (parsaclisib, ibrutinib, rilzabrutinib, zanubrutinib, obexelimab, ianalumab, povetacicept), plasma cells (bortezomib, daratumumab), spleen tyrosine kinase (fostamatinib, sovleplenib), and the neonatal Fc receptor (nipocalimab).

01 Feb 2025·Lancet Haematology

Expanding treatment options for warm autoimmune haemolytic anaemia

Article

Author: Berentsen, Sigbjørn

A review.The treatment landscape for warm autoimmune haemolytic anemia (wAIHA) has gradually shifted from reliance on clin. experience to evidence-based strategies.In a significant contribution to this progress, Zhao et al.Conducted a randomized, placebo-controlled, double-blind phase 2 trial evaluating sovleplenib, an oral selective spleen tyrosine kinase (SYK) inhibitor, in adults with relapsed or refractory wAIHA.Among 21 patients, 67% achieved a Hb response by week 24, with a durable response in 48%.Compared to placebo, sovleplenib reduced transfusion needs and rescue therapy usage, and improved fatigue scores.The drug exhibited a distinct and manageable safety profile.These findings highlight sovleplenib as a promising third-line treatment option, particularly in light of limited efficacy and tolerability seen with other SYK inhibitors like fostamatinib.Further validation in larger phase 3 trials is warranted.Emerging therapies, including FcRn inhibitors, also hold potential, underscoring the evolving complexity of individualized wAIHA treatment.

01 Feb 2025·Lancet Haematology

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

Article

Author: Zhou, Hu ; Li, Fei ; Luo, Xian ; Zhao, Xin ; Li, Yingmei ; Zhang, Zhihua ; Chen, Miao ; Li, Xin ; Han, Bing ; Guo, Xiaojun ; Yin, Hongyan ; Liu, Hong ; Su, Weiguo ; Wang, Xiaoqin ; He, Guangsheng ; Fan, Songhua ; Sun, Jing ; Zhang, Liansheng ; Zhang, Fengkui ; Hong, Mei ; Lei, Lei ; Li, Yang ; Shi, Michael M ; Gong, Tiejun

BACKGROUND:

Spleen tyrosine kinase inhibitors are potential treatment options for warm autoimmune haemolytic anaemia. This study aimed to assess the preliminary efficacy and safety of sovleplenib-an oral spleen tyrosine kinase inhibitor-in patients with warm autoimmune haemolytic anaemia in China. Here we report on the phase 2 results.

METHODS:

This randomised, double-blind, placebo-controlled, phase 2 part from the phase 2/3 study was conducted at 13 centres in China. Eligible patients, aged 18-75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of no more than 2, had primary or secondary warm autoimmune haemolytic anaemia (stable underlying disease not requiring drug intervention) with no response to previous glucocorticoid treatment, haemoglobin of less than 100 g/L with active haemolysis, and a positive direct antiglobulin test. The study comprised two periods; patients were randomly assigned (3:1) to receive sovleplenib or placebo at 300 mg orally once a day in the 8-week double-blind period. Upon completion, all patients entered an open-label treatment period for at least 16 weeks and received sovleplenib 300 mg once a day until 24 weeks after the last patient was randomly assigned. The primary endpoint for phase 2 of the trial was overall haemoglobin response rate (haemoglobin ≥100 g/L with an increase of ≥20 g/L from baseline at least once, and haemoglobin not affected by rescue therapy, such as red blood cell transfusions, intravenous immunoglobulin, and glucocorticoids) by week 24. Efficacy analyses in the 0-8 week double-blind period included all patients who were randomly assigned, analysed by intention-to-treat. Safety analysis in the double-blind period included patients in the intention-to-treat population who received at least one dose of the study medication. This phase 2/3 study is registered with ClinicalTrials.gov, NCT05535933, and the phase 3 part is ongoing.

FINDINGS:

Between Sept 26, 2022, and May 9, 2023, 34 patients were screened and 21 patients (four [19%] male and 17 [81%] female) were enrolled in the study and randomly assigned to receive either sovleplenib (n=16) or placebo (n=5). All 21 patients completed the 0-8-week double-blind treatment and entered the open-label treatment period. The overall haemoglobin response rate was 67% (14 of 21 patients) by week 24, and durable haemoglobin response rate was 48% (ten of 21 patients) by week 24. During the 0-8-week double-blind treatment, 13 (81%) of 16 patients in the sovleplenib group versus five (100%) of five patients taking placebo reported treatment-emergent adverse events (TEAEs), and four (25%) of 16 patients versus four (80%) of five patients reported grade 3 adverse events. Although all 21 patients had a TEAE during the 24-week treatment with sovleplenib, only seven (33%) patients had grade 3 events. The most common grade 3 TEAE was anaemia (four [19%] patients), which was not related to treatment. There were no grade 4 or 5 TEAEs.

INTERPRETATION:

Sovleplenib treatment achieved an encouraging overall haemoglobin response in Chinese patients with warm autoimmune haemolytic anaemia and was well tolerated. The phase 3 part of the study (ESLIM-02) is currently ongoing to further substantiate the efficacy and safety of sovleplenib in this setting.

FUNDING:

HUTCHMED.

News (Medical) associated with Sovleplenib

07 Jan 2026

·firstwordpharma.com

HUTCHMED's sovleplenib secures pivotal win in rare anaemia trial

HUTCHMED announced Tuesday that sovleplenib, an investigational oral spleen tyrosine kinase (Syk) inhibitor, achieved its main efficacy goal in the late-stage registration portion of the ESLIM-02 trial in China for warm antibody autoimmune haemolytic anaemia (wAIHA). The company intends to file a marketing application in this indication with the National Medical Products Administration (NMPA) in the first half of the year.The Phase II/III study enrolled more than 100 adults with primary or secondary wAIHA — the most prevalent form of AIHA — who had relapsed or were refractory to at least one prior line of standard treatment. Participants were randomised to receive either sovleplenib or placebo.Top-line findings showed that the primary endpoint was met, with the sovleplenib arm achieving durable haemoglobin response rates within weeks five to 24 of treatment compared with the placebo arm. "The positive…results… highlight sovleplenib's potential to deliver rapid and durable haemoglobin responses in…patients who have limited options after failing standard therapies," said principal investigator Fengkui Zhang.The latest results align with ESLIM-02's Phase II data, published nearly a year ago in The Lancet Haematology, which demonstrated an overall response rate of 43.8% versus 0% for placebo during the first eight weeks, with the rate hitting 66.7% over 24 weeks of sovleplenib treatment, alongside a favourable safety profile.HUTCHMED is also developing the therapy for immune thrombocytopenia, with an NDA resubmission to the NMPA for second-line use in the condition planned in the first half.

Clinical ResultPhase 2NDA

07 Jan 2026

·www.biospace.com

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 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 8-11%. 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: 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 pro 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 ______________________________ 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.

Phase 2Phase 3Clinical ResultImmunotherapyNDA

27 Nov 2025

·www.globenewswire.com

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ESMO Asia Congress and the 2025 ASH Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 27, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Asia Congress 2025, taking place on December 5-7, 2025 in Singapore, and the American Society of Hematology (“ASH”) Annual Meeting taking place on December 6-9, 2025 in Orlando, USA. Results from a first-in-human study of the anti-CD47 monoclonal antibody HMPL-A83 in advanced solid tumors, as well as from the phase II part of the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma, will be presented at the ESMO Asia Congress 2025. Results from the phase II part of the phase II/III study of surufatinib in combination with camrelizumab and chemotherapy as a first-line treatment for metastatic pancreatic cancer will also be reported. Details of the presentations are as follows: Abstract titlePresenter/Lead authorPresentation detailsESMO Asia Congress 2025 - SPONSORED STUDIES A first-in-human (FIH), dose escalation study of HMPL-A83 (A83), an anti-CD47 monoclonal antibody (mAb) in patients (pts) with advanced solid tumorsYe Guo (Shanghai, China)162MO | Mini Oral session: Developmental therapeutics and precision medicineSunday, December 7, 202511:40 - 11:45 SGTHall 407Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): results from phase 2 part of FRUSICA-2Shanshan Wang (Shanghai, China)540O | Proffered Paper session: Genitourinary tumoursFriday, December 5, 202514:55 - 15:05 SGT Hall 402Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: results from phase 2 part of a randomized, open-label, active-controlled, phase 2/3 studyShukui Qin (Nanjing, China)375P | Poster Display: Gastrointestinal tumours, non‑colorectalOsimertinib (osi) + savolitinib (savo) in EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) with MET overexpression and/or amplification (OverExp/Amp) following progressive disease (PD) on osi: SAVANNAH Asian subsetSe-Hoon Lee (Seoul, Korea)982P | Poster Display: Thoracic tumours, metastaticPatient-relevant Outcomes (PROs) from SACHI: a Phase 3 Trial of Savolitinib (Savo) plus Osimertinib (Osi) versus Chemotherapy (Chemo) in EGFR-mutant (EGFRm) and MET-amplified (METamp) Advanced NSCLC after Progression on EGFR-TKIsYongfeng Yu (Shanghai, China)984P | Poster Display: Thoracic tumours, metastaticAnalysis of MET Amplification (METamp) with FISH and NGS Method in SACHI TrialLonghua Sun (Nanchang, China)988P | Poster Display: Thoracic tumours, metastaticProgression pattern in patients (pts) with EGFR-mutant (EGFRm), MET-amplified (METamp) advanced NSCLC treated with savolitinib (savo) plus osimertinib (osi)Haiyan Yang (Changsha, China)1002P | Poster Display: Thoracic tumours, metastaticMET testing and treatment (tx) sequencing after progression of disease (PD) on first-line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): Final analysis of a global real-world (rw) studyJulia Rotow (Boston, US)1005P | Poster Display: Thoracic tumours, metastatic ESMO Asia Congress 2025 - INVESTIGATOR-INITIATED STUDIES Fruquintinib Combined with TAS-102 with or without SBRT as Third- or Later-Line Treatment in Metastatic Colorectal Cancer: Preliminary Results from a Prospective Phase II TrialChen Zhang/ Yi Wang(Ningbo, China)205P | Poster Display: Gastrointestinal tumours, colorectalEfficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide armGuanghai Dai/ Miaomiao Gou(Beijing, China)245eP | Poster Display: Gastrointestinal tumours, colorectalThe Efficacy and Safety of Fruquintinib (F) Plus FOLFIRI as Second-line (2L) Treatment in Bevacizumab (Bev)-pretreated RAS-mutated (RAS‑m) Metastatic Colorectal Cancer (mCRC)Zhenyang Liu/ Xiaolin Yang(Changsha, China)250eP | Poster Display: Gastrointestinal tumours, colorectalReal-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal CancerXiujuan Qu/ Lin Xu (Shenyang, China)255eP | Poster Display: Gastrointestinal tumours, colorectalMatching-Adjusted Indirect Comparison of Surufatinib versus High-Dose Octreotide LAR in Advanced Extrapancreatic Neuroendocrine TumorsJianming Xu (Beijing, China)214P | Poster Display: Gastrointestinal tumours, colorectalEfficacy and safety of surufatinib in combination with CAPTEM as conversion therapy in patients with unresectable pancreatic neuroendocrine tumors (pNETs): Data updates from a prospective, open-label studyXubao Liu/ Ziyao Wang (Chengdu, China)400P | Poster Display: Gastrointestinal tumours, non‑colorectal Final analysis of long-term results of sovleplenib’s ESLIM-01 China Phase III study in in adult patients with chronic primary immune thrombocytopenia will be presented at the 2025 ASH Annual Meeting. Details of the presentation is as follows: Abstract titlePresenter/Lead authorPresentation details2025 ASH Annual Meeting - SPONSORED STUDIES Phase 3 ESLIM-01 study: Final analysis of efficacy and safety of long-term treatment with sovleplenib in adults with chronic primary immune thrombocytopeniaRenchi Yang (Tianjin, China)843 | Oral Abstract SessionMonday, December 8, 202515:15 - 15:30 EST Room OCCC - W304EFGH About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, ‑2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. About HMPL-A83 HMPL-A83 is an investigational IgG4-type humanized anti-CD47 monoclonal antibody that exhibits high affinity for CD47. HMPL-A83 blocks CD47 binding to Signal regulatory protein (SIRP) α and disrupts the “do not eat me” signal that cancer cells use to shield themselves from the immune system. HUTCHMED currently retains all rights to HMPL-A83 worldwide. About Savolitinib Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS®. About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide. About Sovleplenib 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. 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 but not limited to its expectations regarding the therapeutic potential of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, the further clinical development for fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, its expectations as to whether any studies on fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, HMPL-A83, surufatinib, savolitinib and sovleplenib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as camrelizumab and osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. 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.comBen Atwell / Tim Stamper+44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

Phase 2ImmunotherapyClinical ResultLicense out/inPhase 3

100 Deals associated with Sovleplenib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	NDA/BLA	China	Hutchison MediPharma Ltd.	11 Jan 2024
Purpura, Thrombocytopenic, Idiopathic	NDA/BLA	China	Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.	11 Jan 2024
Autoimmune Haemolytic Anaemias	Phase 3	China	HUTCHMED (China) Ltd.	30 Sep 2022
Warm autoimmune hemolytic anemia	Phase 3	China	Hutchison MediPharma Ltd.	30 Sep 2022
Hemorrhage	Phase 1	United States	HUTCHMED (China) Ltd.	02 Apr 2024
Hemorrhage	Phase 1	Australia	HUTCHMED (China) Ltd.	02 Apr 2024
Hemorrhage	Phase 1	Germany	HUTCHMED (China) Ltd.	02 Apr 2024
Hemorrhage	Phase 1	Norway	HUTCHMED (China) Ltd.	02 Apr 2024
Hemorrhage	Phase 1	Spain	HUTCHMED (China) Ltd.	02 Apr 2024
Skin Manifestations	Phase 1	United States	HUTCHMED (China) Ltd.	02 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05535933 (ESLIM-02, NEWS) Manual	Phase 3	Warm autoimmune hemolytic anemia	-	索乐匹尼布	lybkwezrng(cytyovnklv) = elzysxlyft cphwhbwppv (lhjzjuyyxv ) Met	Positive	07 Jan 2026
NCT05535933 (ESLIM-02, Pubmed \| Lancet Haematol)	Phase 2	Warm autoimmune hemolytic anemia	21	Sovleplenib 300 mg	mqgvpjdwdz(digrpyvbro) = During the 0-8-week double-blind treatment, 13 (81%) of 16 patients in the sovleplenib group versus five (100%) of five patients taking placebo reported treatment-emergent adverse events (TEAEs) nyrauyhigr (vfwyqzeldd ) View more	Positive	01 Feb 2025
				Placebo
NCT05029635 (ESLIM-01, Pubmed) Manual	Phase 3	Chronic idiopathic thrombocytopenic purpura	188	Sovleplenib 300 mg	xmajvdytwy(drhpfdcrsu) = zpftayhoij dbhiybjtsp (raprcrntdy ) View more	Positive	13 Jun 2024
				Placebo	xmajvdytwy(drhpfdcrsu) = mwuyhzxuco dbhiybjtsp (raprcrntdy ) View more
NCT02857998 \| NCT03779113 (EHA2024) Manual	Phase 2	Hodgkin's Lymphoma	25	Sovleplenib 700 mg QD	pvabamtxps(pwlgcjifbf) = eqetqvkhpe djaaxixvti (emxhyyfgwi ) View more	Positive	14 May 2024
NCT05029635 (ESLIM-01, EHA2024) Manual	Phase 3	Purpura, Thrombocytopenic, Idiopathic	188	Sovleplenib	bnjenbmekq(qkxsjgzjbe) = eiimhlvtul qndzbxjbau (zdjhfbcakg ) View more	Positive	14 May 2024
				Placebo	divsvzjgfd(fsxnxppqrz) = divrqoevxa kwmgzpnztu (nypkjobrlr )
NCT05029635 (ESLIM-01, EHA2024) Manual	Phase 3	Purpura, Thrombocytopenic, Idiopathic	188	Sovleplenib 300 mg once daily	gothyvtqgc(ijjnddncig) = etqgticxmd bbpuxewrwn (bvhxkfhshn ) View more	Positive	14 May 2024
				Placebo	hdfywwxthc(ddqliytbpi) = jdrdalpezc apukgkpoqr (yvdfoxaryj )
NCT05535933 (EHA 12024 \| EHA 22024) Manual	Phase 2	Autoimmune Haemolytic Anaemias	21	SOVLEPLENIB	azkpkpsnhd(pmtrkhdxdm) = teqliahoos fzmtdzuiwg (pionhfpdfe ) View more	Positive	14 May 2024
				Placebo	azkpkpsnhd(pmtrkhdxdm) = ootwmxpscl fzmtdzuiwg (pionhfpdfe ) View more
NCT05029635 (ESLIM-01, EHA 12024 \| EHA 22024) Manual	Phase 3	Purpura, Thrombocytopenic, Idiopathic	188	sovleplenib	gchdzqriht(csinqabddg) = rlxtlynsuq mgjabfsgfp (xsfwwdacjx ) View more	Positive	14 May 2024
				Placebo	gchdzqriht(csinqabddg) = khwmlltmnt mgjabfsgfp (xsfwwdacjx ) View more
NCT03779113 (AACR2024) Manual	Phase 1	Lymphoma	47	HMPL-523 700 mg QD	jpimrpzfxn(fimfictnji) = alfucrpirz ajftaishvg (thjcmkldvg ) View more	Positive	05 Apr 2024
NCT05029635 (ESLIM-01, Corporate Publications) Manual	Phase 3	Purpura, Thrombocytopenic, Idiopathic	188	索乐匹尼布	kfmdjdfkfr(bmfyhbaadp) = 该试验成功达到了其主要终点，即与接受安慰剂治疗的患者相比，接受索乐匹尼布治疗的患者的持续应答率取得了具有临床意义和统计学意义的显著改善。 kiayugyekn (teqwdiilji ) Met View more	Positive	21 Aug 2023
				安慰剂

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