Zimberelimab

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

Gilead Sciences has axed half a dozen programmes from its portfolio, including candidates partnered with Novo Nordisk and Arcus Biosciences. The pipeline cull was disclosed in the company's second-quarter financial report on Thursday, when it also announced encouraging early uptake for its HIV prevention shot Yeztugo (lenacapavir) (see – Spotlight On: With Yeztugo's launch off to the races, Gilead ups HIV guidance).The pipeline prioritisation hit four cancer programmes, an experimental infectious disease asset, and Gilead's final metabolic dysfunction-associated steatohepatitis (MASH) hopeful. The drugmaker had been developing a triple-combination MASH treatment in collaboration with Novo Nordisk since at least 2020. The cocktail, comprising the Danish pharma's GLP-1 blockbuster semaglutide along with Gilead's experimental drugs cilofexor and firsocostat, was studied in the Phase II WAYFIND study.The discontinued candidates from Arcus also date back to a 2020 partnership pegged to last a decade. At the time, Gilead paid $175 million upfront and made a $200-million equity investment to co-develop and co-commercialise cancer immunotherapies from Arcus' pipeline — notably, the PD-1 inhibitor zimberelimab and several anti-TIGIT programmes, although the allure of TIGIT has since faded drastically following a number of high-profile setbacks within the class (see – Spotlight On: AstraZeneca leads TIGIT charge as another one bites the dust).In 2021, Gilead exercised options for several additional assets including etrumadenant, a dual adenosine A2a/A2b receptor antagonist, and the small-molecule CD73 inhibitor quemliclustat; both were pruned from the drugmaker's pipeline on Thursday.  The partners had been studying etrumadenant in combination with zimberelimab in the Phase II ARC-9 study for metastatic colorectal cancer, while quemliclustat was being evaluated in the Phase II ARC-8 trial in patients with metastatic pancreatic ductal adenocarcinoma, with or without the PD-1 inhibitor. Separate from the Arcus partnership, Gilead also cut two Phase I oncology programmes from its portfolio: MCL1 inhibitor GS-9716 and DGKα inhibitor GS-9911.The sixth asset to get the axe was the oral antiviral obeldesivir, specifically as a treatment for respiratory syncytial virus (RSV) in both children and adults. Gilead's decision to end development in RSV doesn't come as a surprise, as two trials were terminated in June due to "lower than expected" RSV infection incident rates. At the time, Gilead told FirstWord that a 400-person Phase II study of obeldesivir in Marburg virus disease was continuing as planned. The antiviral also failed the Phase III OAKTREE trial last year after it didn't improve time to symptom alleviation versus placebo in non-hospitalised COVID-19 patients without risk factors for severe disease.