Savolitinib

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

Nov. 04, 2025 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with epidermal growth factor receptor (“EGFR”)-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small cell lung cancer (“NSCLC”) following progression on treatment with TAGRISSO®. The last patient was randomized on October 31, 2025. This combination represents a promising, chemotherapy-free, all-oral treatment option following progression on an EGFR tyrosine kinase inhibitor (“TKI”), and was granted approval in China in June 2025 based on the results of the SACHI randomized Phase III trial. ORPATHYS® is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO® is a third-generation, irreversible EGFR TKI. SAFFRON is a global Phase III, open-label, randomized, multicenter study to investigate the efficacy and safety of ORPATHYS® administered orally in combination with TAGRISSO® versus platinum-based doublet chemotherapy in participants with EGFR-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with TAGRISSO® as the most recent therapy. The primary endpoint of the study is progression free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. Other endpoints include overall survival (OS), objective response rate (“ORR”), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. This study randomized 338 patients, screened from over 230 sites across 29 countries. Additional details may be found at clinicaltrials.gov, using identifier NCT05261399. Topline results from the SAFFRON study are estimated to be reported in the first half of 2026, followed by submission of results for presentation at an appropriate medical congress. If favorable, the results could support global regulatory filings for the ORPATHYS® and TAGRISSO® combination. Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2 The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated (“EGFRm”) NSCLC.3,4,5,6,7 MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.8,9 ORPATHYS® (savolitinib) is an oral, potent and highly selective MET TKI 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. ORPATHYS® is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, representing the first selective MET inhibitor approved in China. ORPATHYS® is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO®. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines. TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO® (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO® as a treatment for patients across multiple stages of EGFRm NSCLC. There is an extensive body of evidence supporting the use of TAGRISSO® in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease. In late-stage disease, TAGRISSO® demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO® is also being investigated in this setting in combination with ORPATHYS® (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY® (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials. TAGRISSO® also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO® is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial. This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this setting. Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO® is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS® in combination with TAGRISSO® has been studied extensively in these patients in the TATTON study (NCT02143466) and the SAVANNAH single-arm Phase II study (NCT03778229). Strong data from SAVANNAH presented at the 2025 European Lung Cancer Congress (ELCC) demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The encouraging results led to the initiation of several randomized Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836). 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. 1 World Health Organization. International Agency for Research on Cancer. All cancers fact sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf. Accessed November 2022. 2 American Cancer Society. What is Lung Cancer? Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed November 2022. 3 Knight SB, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9): 170070. 4 Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. 5 Zhang Y, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48). 6 Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12. 7 Gou LY, et al. Prevalence of driver mutations in non-small-cell lung cancers in the People’s Republic of China. Lung Cancer: Targets and Therapy. 2014; 5; 1–9. 8 Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074). 9 Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. Journal of Hematology & Oncology. 2019;63. The content above comes from the network. if any infringement, please contact us to modify.