RegulationOrphan Drug (United States), Breakthrough Therapy (China), Special Review Project (China), Orphan Drug (Japan), Conditional marketing approval (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC22H19FN4O2

InChIKeySZMJVTADHFNAIS-BJMVGYQFSA-N

CAS Registry1616493-44-7

330

Clinical Trials associated with Chidamide

ChiCTR2500110820

/ Not yet recruitingEarly Phase 1IIT

A Prospective Study of Chidamide Combined with Venetoclax in the Treatment of Newly Diagnosed Adult T-Lymphoblastic Lymphoma/T-Cell Acute Lymphoblastic Leukemia

Start Date01 Oct 2025

Sponsor / Collaborator

Jining Medical College Affiliated Hospital

NCT06556862

/ Not yet recruitingPhase 2IIT

Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase II Study

A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.

Start Date01 Oct 2025

Sponsor / Collaborator

302 Military Hospital of China

ChiCTR2500110497

/ Not yet recruitingPhase 2IIT

A cohort, open-label, phase II clinical study of chidamide combined with tislelizumab and anlotinib in the treatment of advanced esophageal cancer

Start Date01 Oct 2025

Sponsor / Collaborator

The First Affiliated Hospital of Zhengzhou University

100 Clinical Results associated with Chidamide

100 Translational Medicine associated with Chidamide

100 Patents (Medical) associated with Chidamide

2,371

Literatures (Medical) associated with Chidamide

01 Feb 2026·NUTRITION

Natural histone deacetylase inhibitions from legumes: Exploring epigenetics modulation through systems biology

Review

Author: Farooqi, Humaira ; Aqeel, Aatiquah ; Choudhary, Furqan ; Nizam, Anam ; Rizwan, Amber ; Khan, Asiya

Epigenetic regulation, particularly histone deacetylases (HDACs), is critical for gene expression, chromatin remodeling, and cellular function. While synthetic HDAC inhibitors (HDACi) have shown promise in cancer treatment, their clinical utility is frequently constrained by toxicity, poor isoform specificity, and inferior performance in solid tumors. In recent years, there has been a rising focus on natural chemicals, particularly (poly)phenols produced from legumes, as safer and more selective alternatives. This review comprehensively examines the existing literature on legume-derived (poly)phenols, including genistein, daidzein, quercetin, and kaempferol, and their role as natural HDACis. It discusses their chemical diversity, HDAC inhibitory mechanisms, epigenetic influence, and associated biological activities such as anti-inflammatory, anticancer, and neuroprotective properties. In vitro and in vivo research on HDAC regulation by legume (poly)phenols are rigorously explored, as well as comparative insights into synthesized HDACi. This article also covers bioavailability issues, metabolism, and formulation options for improving therapeutic efficacy; highlights the therapeutic potential of legume (poly)phenols as epigenetic modulators by combining findings from molecular, pharmacological, and nutritional investigations: and calls for additional research into their use in nutraceutical development and disease treatment.

01 Jan 2026·Genes & Diseases

Transcriptomic landscapes underlying response and resistance to HDAC inhibitor chidamide in triple-negative breast cancer

Article

Author: Li, Guanjie ; Xiang, Qin ; Zhang, Yanxia ; Liu, Yunduo ; Zhang, Mei ; Xiao, Bin ; Li, Linhai ; Xie, Keping ; Wu, Shunhong

01 Dec 2025·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Recent progress in synthetic strategies to develop potent, HDAC8-selective, small-molecule inhibitors

Review

Author: Fletcher, Steven ; Lowe, Brandon D

Key players in epigenetic control, the 11 zinc-dependent histone deacetylase (HDAC) enzymes have been affirmed as therapeutic targets, particularly in the discovery of new chemotherapy drugs: currently there are 3 FDA-approved pan-HDAC inhibitors (HDACi's), although these are not without their side effects. It has been rationalized that achieving HDAC isoform-selective inhibitors may yield safer drugs. HDAC8 has recently been validated as a novel target for the treatment of (pediatric) neuroblastoma, and its overexpression has been implicated in a range of other diseases. Herein, we discuss the topology of the HDAC8 active site in the context of inhibitor design, and we present recent progress in the discovery of potent, HDAC8-selective small-molecule inhibitors, with a discussion on the particular structural criteria required. HDACi's largely conform to a canonical pharmacophore model of a capping group connected via a linker to a zinc binding group (ZBG), which is typically a (potentially mutagenic) hydroxamic acid. In particular, for HDAC8-selectivity, the small-molecule should adopt a geometric "L"-shape, which may be accomplished by the linker itself, or the linker and capping group. More recently, HDAC isoform selectivity has been realized with hydroxamic acid surrogates, such as ortho-aminoanilides that yield potent and HDAC1-3-selective (but HDAC8-inactive) inhibitors. Hydrazides have long been utilized as bioisosteres of hydroxamic acids in HDAC inhibitor design, but a recent re-visiting explored the attachment of alkyl groups, and an n-hexyl substituent on the distal, non-acylated nitrogen affords potent and selective HDAC8 inhibitors probably through targeting the foot pocket of the active site; this discovery was observed across three different HDACi scaffolds, and thus appears quite general. α-Aminoketo ZBGs have also demonstrated HDAC8-selectivity, with associated benzylic moieties likewise engaging the foot pocket. We speculate that a re-imagining of the ortho-aminoanilide ZBG through a careful and methodical survey of related moieties, may lead to the discovery of additional HDAC8-selective ZBGs towards the realization of safe, pre-clinical inhibitors. 2025 Elsevier Ltd. All rights reserved.

News (Medical) associated with Chidamide

27 Nov 2025

·cerenoscientific.com

Cereno Scientific Publishes Interim Report for Q3 2025 (July 1 – September 30, 2025)

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the Board of Directors and Chief Executive Officer of Cereno Scientific AB here presents the Interim Report for Q3 2025 (July 1 – September 30, 2025). Financial overview Cereno Scientific Group – Q3 Net Sales were SEK 0 (0) Result after financial items was SEK -21 321 915 (-22 718 087) Earnings per share was SEK -0.07 (-0.08) before dilution and SEK -0.07 (-0.07) after dilution The equity/assets ratio was 49.5% (66.8%) Cash and bank balance was SEK 74 179 974 (73 841 665) Parent company – Q3 Net Sales were SEK 0 (0) Result after financial items was SEK -22 323 425 (-22 718 087) Earnings per share was SEK -0.07 (-0.08) before dilution and SEK -0.07 (-0.07) after dilution The equity/assets ratio was 49.5% (66.8%) Cash and bank balance was SEK 74 096 722 (73 791 605) Significant events during the third quarter On July 1, Cereno Scientific was added to Nasdaq’s First North 25™ Index, reflecting its status as one of the most traded securities on the First North Growth Market. On July 4, Cereno Scientific selected a top-tier global CRO to conduct the upcoming Phase IIb trial of CS1 in the rare disease pulmonary arterial hypertension. On July 15, Cereno Scientific announced positive topline results from the Phase I trial of CS014, in which the primary endpoint was met. CS014 was well tolerated with favorable safety and exposure profiles in healthy volunteers, providing data that support advancement into Phase II development. In August, a conversion of convertibles amounting to SEK 25 million was requested by Fenja Capital II A/S and Arena Investors, LP. On September 15, Cereno Scientific Announces Conversion of All Remaining Convertibles Following Request by Fenja Capital II A/S and Arena Investors, LP On September 3, CEO Sten R. Sörensen was announced a finalist for ‘CEO of the Year’ at the European Lifestars Awards 2025. The Awards celebrate the achievements from remarkable breakthroughs to transformational investments and deals of the exceptional individuals, teams, and organizations that have shaped the life science industry over the past 12 months. The ‘CEO of the Year’ category recognizes leaders who have demonstrated outstanding career achievements, created shareholder value, forged impactful partnerships, and influenced the wider life science industry. Cereno Scientific participates at several key partnering and investor conferences during the period: GoCo Investor Day on September 9 and Nordic Life Science Days 2025 on October 8-9. and Recordings of the presentations are available on our website, https://cerenoscientific.com/events-presentations/. Significant events after the period Cereno Scientific participated at BIO-Europe Fall 2025 in Vienna on November 3-5, which is one of the main global biopharma partnering events of the year. On November 11, Cereno Scientific receives SEK 4 million through exercise of 600,000 warrants by Arena Investors, LP. This was in connection with the financing agreement being entered into on November 11, 2024. On November 10, the submission of the clinical trial protocol for the planned global Phase IIb trial of lead drug candidate CS1 was sent to the U.S. Food and Drug Administration (FDA). The submission marks an important milestone, moving the company closer to advancing CS1 into its next clinical phase and toward bringing a novel therapeutic approach to patients living with pulmonary arterial hypertension (PAH). Cereno Scientific anticipates clearance to proceed with the trial following the FDA’s standard 30-day review. Letter from the CEO Advancing toward the next phase The third quarter of 2025 has been a very productive and defining period for Cereno Scientific. As we move through the final weeks of the year, we continue to build strong momentum across our clinical pipeline and strengthen our foundation for the next phase of growth. Our focus remains on advancing our pioneering HDAC inhibitor portfolio, increasing recognition of our scientific platform, and pursuing the next major milestones that will propel our growth journey. CS1: Advancing toward Phase IIb with FDA alignment Following the positive regulatory interactions earlier this year, we reached a major milestone in November with the submission of the clinical trial protocol for our planned global Phase IIb trial of CS1 to the U.S. Food and Drug Administration (FDA). This submission moves us closer to initiating the clinical Phase IIb trial in H1 2026, and we anticipate FDA's greenlight within the next few weeks. The protocol has been developed in alignment with the FDA’s guidance from our Type C meeting, ensuring that the study design meets regulatory expectations and is positioned to support late-stage development. The upcoming trial will build on the encouraging results from our successful Phase IIa study, which demonstrated that CS1 has a favorable safety and tolerability profile and showed promising efficacy signals, including improvements in right heart function and patient quality of life. We will further evaluate the safety, tolerability and efficacy of different doses of CS1, including the potential to reverse vascular remodeling, improve right heart function and patient quality of life. These findings, together with preclinical data indicating the potential to reverse pathological vascular remodeling, form a strong foundation for further evaluation in the Phase IIb study. With FDA Fast Track designation in place and strong regulatory alignment, we are progressing with confidence as we work to advance CS1 as a novel, disease-modifying therapy for patients living with pulmonary arterial hypertension (PAH). CS014: Positive Phase I data supports advancement to Phase II In mid-July, we announced positive topline results from our first-in-human Phase I study of CS014. The trial met its primary endpoint, demonstrating a favorable safety and tolerability profile in healthy volunteers. Importantly, we saw that CS014 achieved blood concentrations expected, based on non-clinical data, to impact disease-driving fibrosis and vascular remodeling. Together with its strong preclinical data, these results form a solid foundation for advancing CS014 into Phase II development. CS014 represents our second HDAC inhibitor program and holds potential not only in idiopathic pulmonary fibrosis (IPF), our initial target indication, but also in other fibrotic and vascular diseases where few effective treatment options exist. Building on the Phase I results, we see a broadening of CS014’s clinical potential and are refining our development strategy to best leverage its therapeutic promise. This may include opportunities to expand our impact across rare disease with significant unmet needs. The successful completion of this Phase I study marks another significant milestone for Cereno’s HDACi platform and further strengthens our position at the forefront of innovation in cardiovascular and pulmonary medicine. Strengthening the scientific platform for HDAC inhibition Recent months have also seen a notable increase in scientific publications highlighting the potential of HDAC inhibition in cardiovascular and pulmonary disease. This growing body of external research combined with our own research emphasizes the importance of addressing disease-driving mechanisms such as fibrosis, inflammation and vascular remodeling, which aligns closely with our own development strategy. As the first clinical-stage company advancing HDAC inhibitors specifically for cardiovascular and pulmonary diseases, Cereno Scientific is well positioned within this rapidly evolving scientific landscape. CS585: Continuing preclinical progress Our third program, CS585, a selective prostacyclin (IP) receptor agonist, continues to progress in preclinical development through our collaboration with the University of Michigan. Data generated to date support its potential as a differentiated treatment approach for rare thrombotic diseases by preventing thrombosis without increasing bleeding risk, which is a key unmet need in cardiovascular medicine. Expanding our scientific footprint Our scientific visibility continues to grow, supported by several important activities across the global research community. After the end of the period, the first manuscript describing the structure and supportive non-clinical data for CS014 was accepted in the respected Journal of Thrombosis & Haemostasis. This peer-reviewed publication provides external validation of our scientific approach and strengthens the foundation for the continued development of our second HDAC inhibitor program. Our CSO, Björn Dahlöf, will represent Cereno Scientific at the annual, invitation-only CVCT Forum in Washington, D.C., and participate in two panel discussion. This key event brings together leading experts from industry, academia and regulatory agencies to discuss advances in cardiovascular clinical trial design. The team is also preparing for several upcoming scientific conferences. In mid-December, we will present the CS014 Phase I data to a scientific audience for the first time at Pharmacology 2025, hosted by the British Pharmacological Society. Further results will also be shared at the Pulmonary Vascular Research Institute (PVRI) annual congress in early 2026, providing important opportunities to engage with global leaders in pulmonary vascular disease. Strengthening Cereno’s position, visibility and growth Cereno Scientific’s visibility and reputation as a pioneering biotech company continued to grow during the quarter. In this context, I was honored to be named a finalist for “CEO of the Year” at the European Lifestars Awards 2025. This recognition reflects the importance of committed leadership in navigating the complexities of drug development, building strong relationships across the industry, and keeping a clear long-term vision centered on patient need. Throughout the autumn, we have maintained a high level of activity across the investor and partnering landscape. This included participation at Nordic Life Science Days in Gothenburg and GoCo Investor Day during the quarter, followed by BIO-Europe Fall in Vienna and London Life Sciences Week 2025 after the period.* At BIO-Europe, our CMO and Head of R&D, Rahul Agrawal, was invited to speak on an engaging panel hosted by IQVIA Institute for Human Data Science focused on access to the US market for European biotechs. These engagements are important for broadening our network, supporting ongoing dialogue with investors and potential partners, and sharing updates on our clinical and corporate progress. During the quarter, all remaining convertibles held by Fenja Capital II A/S and Arena Investors LP were converted into shares, completing the conversion of SEK 75 million convertible loan held by the debt providers. After the end of the period, Arena Investors also exercised 600,000 warrants, providing SEK 4 million in proceeds. Looking ahead As we approach year-end, our focus is on maintaining operational drive and pipeline momentum. With two HDAC inhibitor programs advancing and a promising preclinical candidate in CS585, we are well positioned for continued progress in 2026. Every milestone, from clinical advancement to scientific recognition and growing industry visibility, brings us closer to our mission of developing pioneering treatments that enhance and extend life for patients living with rare cardiovascular and pulmonary diseases. The growing awareness of Cereno's pioneering efforts during 2025 is also a testament to the dedication of our team, the value of our partnerships, and the trust of our shareholders. Thank you for your continued support as we take the next steps toward this new stage for Cereno Scientific. November 2025 Sten R. Sörensen, CEO Financial calendar Year-end Report, Q4 2025……...............................February 27, 2026 For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 73- 236 62 46 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. The company’s innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the fullest. Lead candidate CS1 is an HDAC inhibitor that works through epigenetic modulation and represents a novel therapeutic approach by targeting the root mechanisms of the pulmonary arterial hypertension (PAH). CS1 is a well-tolerated oral therapy with a favorable safety profile that has shown encouraging efficacy signals of reverse vascular remodeling and improvement of right heart function as observed in a Phase IIa trial in patients with PAH. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1 CS014, a new chemical entity with disease-modifying potential, showed favorable safety and tolerability profile in a Phase I trial. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

Phase 1Phase 2Clinical Result

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

05 Sep 2025

·www.globenewswire.com

HUTCHMED Highlights Clinical Data to be Presented at the 2025 World Conference of Lung Cancer and the CSCO Annual Meeting 2025

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 05, 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 2025 World Conference on Lung Cancer (“WCLC”) taking place on September 6-9, 2025 in Barcelona, Spain, and the Chinese Society of Clinical Oncology (“CSCO”) Annual Meeting 2025, taking place on September 10-14, 2025 in Jinan, China. Updated analysis from savolitinib’s SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer (“NSCLC”) patients will be presented at WCLC 2025. Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Details of the WCLC 2025 presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLCChristina Baik, University of Washington and Fred Hutchinson Cancer Center, Seattle, USAMA03.03Mini Oral: New Advances in Circulating BiomarkersRoom 06Sunday, September 7, 20253:15 - 4:30PM CESTEfficacy and Safety of Savolitinib in Advanced or Metastatic METex14 NSCLC Patients With or Without Prior ImmunotherapyYongfeng Yu, Shanghai Chest Hospital, Shanghai, ChinaP3.12.48Poster: Metastatic NSCLC – Targeted TherapyTuesday, September 9, 2025Frontline Treatment Duration in MET-Amplified NSCLC After Third-Generation EGFR-TKI Failure: SACHI Study InsightsLijuan Chen, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, ChinaP3.12.64Poster: Metastatic NSCLC – Targeted TherapyTuesday, September 9, 2025Osimertinib + Savolitinib in EGFRm Advanced NSCLC With MET Overexp And/Or Amp Post-Progression on Osimertinib: SAVANNAH PROsSilvia Novello, University of Turin, San Luigi Hospital, Turin, ItalyPT2.12.04ePoster: Metastatic NSCLC – Targeted TherapyMonday, September 8, 2025INVESTIGATOR-INITIATED STUDIESEfficacy and Safety of Surufatinib, Durvalumab in Combined with Chemotherapy as First-line Treatment of Extensive-stage Small-cell Lung CancerHui Zhang/ Ying Hu, Beijing Chest Hospital, Beijing, ChinaP3.13.22Poster: Small Cell Lung Cancer and Neuroendocrine TumorsTuesday, September 9, 2025 Clinical data of HMPL-653, a novel, selective and potent CSF-1R inhibitor, from a first-in-human Phase I study in patients with tenosynovial giant cell tumor in China will be presented for the first time at the CSCO Annual Meeting 2025. Details of the CSCO Annual Meeting 2025 presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES A first-in-human phase I study of HMPL-653, a CSF-1R inhibitor, in patients with tenosynovial giant cell tumorXiaohui Niu25297Oral SessionFriday, September 12, 202515:00 - 15:12PM HKTINVESTIGATOR-INITIATED STUDIES Fruquintinib Plus Serplulimab as First-Line Therapy in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (nccRCC): Updated Efficacy and Safety from a Multicenter, Single-Arm TrialJiwei Huang/ Wei Xue23258Oral SessionThursday, September 11, 202516:50 - 17:15PM HKTFruquintinib plus camrelizumab combined with paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): updated data from a single-arm, phase II clinical trialTianzhu Qiu/ Yanhong Gu23766Oral SessionFriday, September 12, 202511:20 - 12:00 noon HKTFruquintinib plus chemotherapy as second-line therapy in metastatic colorectal cancer: a multicenter, open-label, phase II clinical trialYongshun Chen22084Poster SessionEfficacy and Safety of Neoadjuvant Fruquintinib plus Toripalimab and Short-Course Radiotherapy (SCRT) for Locally Advanced Rectal Cancer: Updated Results from a Phase II Clinical TrialZhiping Li21915AbstractFruquintinib combined with chemotherapy as first-line treatment for advanced metastatic colorectal cancer: a propensity score-matched comparison of efficacy between a prospective single-arm cohort and a retrospective observational cohortFuxiang Zhou23550AbstractEfficacy 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 armMiaomiao Gou23591AbstractPhase ll Clinical Study of Surufatinib Combined with Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract CancerMiaomiao Gou23610Oral SessionFriday, September 12, 202516:53 - 16:59PM HKTA single-arm, Phase Ib/II trial of surufatinib plus KN046 and gemcitabine and nab-paclitaxel as first-line treatment for unresectable advanced pancreatic cancerWenquan Wang/ Liang Liu23783Oral SessionThursday, September 11, 202516:20 - 16:35PM HKTUpdated results of surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trialDan Cao22652Poster SessionSurufatinib in patients with soft tissue myeloma who have failed first-line standard chemotherapy or anlotinib: a multicenter, prospective, two-cohort, phase II clinical studyYuhong Zhou/ Xi GuoP80Poster SessionEfficacy and Mechanistic Study of the NASCA Regimen (Surufatinib Combined with Camrelizumab, Nab-Paclitaxel, and S-1) in Advanced Pancreatic Cancer Patients with Liver MetastasisGuanghai Dai/ Ru Jia22309AbstractA Phase II, Single-Arm Study of Surufatinib Combined with Zimberelimab and Nab-Paclitaxel in Patients with Advanced Triple-Negative Breast Cancer: Data UpdateCaixia Wang23679AbstractEfficacy and safety of surufatinib combined with gemcitabine, cisplatin and immune checkpoint inhibitor for the treatment of unresectable locally advanced or metastatic intrahepatic cholangiocarcinomaXuetao Shi/ Jingtao Zhong24133AbstractEfficacy and Safety of Surufatinib in Patients with Neuroendocrine Neoplasms: A Multicenter Retrospective StudyJiang Long24294Abstract 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, surufatinib, savolitinib and HMPL-653, the further clinical development for fruquintinib, surufatinib, savolitinib and HMPL-653, its expectations as to whether any studies on fruquintinib, surufatinib, savolitinib and HMPL-653 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, surufatinib, savolitinib and HMPL-653, 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, surufatinib, savolitinib and HMPL-653 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products 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 / Alex Shaw+44 7771 913 902 (Mobile) / +44 7779 545 055 (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 ResultPhase 1Drug Approval

100 Deals associated with Chidamide

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KEGG	Wiki	ATC	Drug Bank
-	Chidamide	L01XX	DB06334

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	China	Shenzhen Chipscreen Biosciences Co., Ltd.	24 Apr 2024
Adult T-Cell Leukemia-Lymphoma	Japan	Meiji Seika Pharma Co., Ltd.	23 Jun 2021
Hormone receptor positive HER2 negative breast cancer	China	Shenzhen Chipscreen Biosciences Co., Ltd.	20 Nov 2019
Peripheral T-Cell Lymphoma	China	Shenzhen Chipscreen Biosciences Co., Ltd.	23 Dec 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Unresectable Colorectal Carcinoma	Phase 3	China	Shenzhen Chipscreen Biosciences Co., Ltd.	27 Nov 2024
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 3	China	Sun Yat-Sen University	01 Mar 2023
Microsatellite Stable Colorectal Carcinoma	Phase 3	China	Sun Yat-Sen University	01 Mar 2023
Brain metastases	Phase 3	United States	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Japan	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Australia	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Austria	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Belgium	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Brazil	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Czechia	Huyabio International LLC	12 Aug 2021

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05976997 (ASH2025)	Phase 2	Immunoblastic Lymphadenopathy First line	12	Duvelisib + Chidamide + CHOP chemotherapy	omhtltvgwo(yyzbnfcumx) = mainly hematological toxicity, including leucopenia (41.7%)and neutropenia (41.7%), as well as infections including lung infections 33.3% npeqakieaq (vrfldkhaqi ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Acute Myeloid Leukemia	51	The ABC-14 regimen (Azacitidine, Venetoclax, and Chidamide)	jqgohrwgxc(sehgkltjcu) = Rates of 100-day and overall CMV/EBV infection were similar between the groups chcfknglvy (iozaaiqqyr ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Acute Myeloid Leukemia	51	Intensive chemotherapy (IC)		Positive	06 Dec 2025
ChiCTR2300073233 (ASH2025)	Phase 4	Diffuse large B-cell lymphoma recurrent	31	Chidamide+BTK inhibitors	mkkxmhbife(grhfxeeubd) = the most common hematologic toxicities observed were grade ≥3 neutropenia (35%) and grade ≥3 thrombocytopenia (32%). Two patients (6%) had pneumonia, and one patient (3%) had herpes zosters. oyxjitelri (qisfexdbya ) View more	Positive	06 Dec 2025
ASH2025	Phase 2	-	100	Venetoclax-Azacitidine-Chidamide Plus CAG (CACAG-VEN)	yypeyxxusz(ownvwpxohs) = lfjabhaluo idgaehulrk (rojqqqpzfj ) View more	Positive	06 Dec 2025
ASH2025	Phase 2	-	100	“3+7” regimen	yypeyxxusz(ownvwpxohs) = ovghuapgnb idgaehulrk (rojqqqpzfj ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Primary Central Nervous System Lymphoma	11	Chidamide + methotrexate + ifosfamide + etoposide + doxorubicin liposomes + dexamethasone	vcusuobgmc(ppbvajfpii) = The most common adverse events were hypocytosis and gastrointestinal symptoms. Grade 4 hematological toxicity occurred in 2 patients. No patients died of toxicity. oihoxrbfgc (gnvygkzmxk ) View more	Positive	06 Dec 2025
NCT05367856 (ASH2025)	Phase 2	Peripheral T-Cell Lymphoma	23	Chidamide+BEAM+ASCT	hhptrighvv(okdcjndbsc) = vwdtfcxihi mntyjwyeer (wlfgykmimh, 72.9 - 99.4) View more	Positive	06 Dec 2025
NCT04231448 (DEB, ASH2025)	Phase 3	Diffuse Large B-Cell Lymphoma MYC \| BCL2	423	Tucidinostat plus R-CHOP	solwbxjlyz(smvhulnshv) = usriwukpvy uqrhyxnxhn (dvwegkfoad ) View more	Positive	06 Dec 2025
NCT04231448 (DEB, ASH2025)	Phase 3	Diffuse Large B-Cell Lymphoma MYC \| BCL2	423	Placebo plus R-CHOP	solwbxjlyz(smvhulnshv) = chqpfkbotp uqrhyxnxhn (dvwegkfoad ) View more	Positive	06 Dec 2025
ASH2025	Phase 2	Peripheral T-Cell Lymphoma First line	20	Chidamide + Azacitidine + Mitoxantrone liposomes + Prednisone	lnqxzlscss(vxfisoimlh) = qkotyqcsfs jswlvfiezr (wjjbltnfuw ) View more	Positive	06 Dec 2025
NCT05991973 (ASH2025)	Phase 2	Precursor T-Cell Lymphoblastic Leukemia-Lymphoma \| Lymphoma Maintenance	44	Chidamide 10 mg	usjrgoxllp(mtypjecsyx) = olrakmqtza bvxbefofog (jjfcqauspe, 75.8 - 97.1) View more	Positive	06 Dec 2025
NCT06068621 (ASH2025)	Phase 3	Acute Myeloid Leukemia First line	170	Venetoclax-azacitidine in combination with chidamide and CAG (cytarabine, aclarubicin, granulocyte colony-stimulating factor)	wsiaiejesf(iuohkwstqx) = viazoamair uepfitkwcy (qpiwonmtbk ) View more	Positive	06 Dec 2025
NCT06068621 (ASH2025)	Phase 3	Acute Myeloid Leukemia First line	170	daunorubicin and cytarabine	wsiaiejesf(iuohkwstqx) = rlwkgrvpit uepfitkwcy (qpiwonmtbk ) View more	Positive	06 Dec 2025

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