Surufatinib

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 02, 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”) Congress 2025, taking place on October 17-21, 2025 in Berlin, Germany. Results from 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 in a Mini Oral session. Additionally, further analyses of the fruquintinib FRUSICA-1 study in endometrial cancer and the savolitinib SACHI and SAVANNAH studies in non-small cell lung cancer will be presented during the poster sessions. Details of the presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): results from phase 3 part of a randomized, open-label, active-controlled phase 2/3 study (FRUSICA-2)Zhenhua Liu(Chengdu, China)2592MOMini Oral Session 1: GU tumours, renal & urothelialFriday, Oct 17, 2025Karlsruhe Auditorium - Hall 5.216:00 - 17:30 CESTA Fruquintinib Expanded Access Program (EAP) to Provide Treatment for Patients With Metastatic Colorectal Cancer (mCRC)Stefan Kasper-Virchow (Essen, Germany)794P Poster Session:Colorectal cancerFruquintinib plus tislelizumab in microsatellite stable metastatic colorectal cancer: Results from a phase 1b/2 studyN. Arvind Dasari (Houston, USA)799PPoster Session:Colorectal cancerA novel artificial intelligence (AI) imaging biomarker of tumor vascularity and heterogeneity radiomics to predict survival benefit of fruquintinib vs placebo in metastatic colorectal cancer (mCRC)Sara Lonardi (Padua, Italy)804PPoster Session:Colorectal cancerSafety and tolerability of fruquintinib: Pooled analysis of three placebo-controlled studies in patients with metastatic colorectal cancerCathy Eng (Nashville, USA)811PPoster Session:Colorectal cancerAssociation between Metabolic Syndrome (MetS) and clinical outcomes of Fruquintinib plus Sintilimab in Previously Treated Advanced Endometrial Cancer (EMC) Patients with pMMR Status: results from FRUSICA-1 studyDanbo Wang (Shenyang, China)1230eP Poster Session:Gynaecological CancerctDNA analysis in phase 3 SACHI trial: savolitinib (savo) plus osimertinib (osi) versus chemotherapy (chemo) in MET-amplified (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI)Yongfeng Yu (Shanghai, China)1954P Poster Session: NSCLC, metastaticSAVANNAH: Safety and tolerability of osimertinib (osi) + savolitinib (savo) in EGFRm advanced NSCLC with MET overexpression and/or amplification (OverExp/Amp) following disease progression on osiQuincy Siu-chung Chu (Edmonton, Canada)1955P Poster Session: NSCLC, metastaticMET testing and treatment (tx) sequencing after progression on first line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): interim analysis of a global real world (rw) studyJulia Rotow (Boston, USA)1956P Poster Session: NSCLC, metastatic INVESTIGATOR-INITIATED STUDIES Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated surgical and survival results from the single-arm, phase 2 clinical trialFei Ma (Zhengzhou, China)2159P Poster Session: Oesophagogastric cancerFruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, Phase II StudyWangjun Liao (Guangzhou, China)898ePE-poster Session:Colorectal cancerThe efficacy and safety of surufatinib combined with chemotherapy in the first-line treatment of advanced periampullary carcinoma: a single arm, prospective, exploratory clinical studyQianqian Wang (Nanjing, China)929P Poster Session: Developmental therapeuticsSurufatinib-Based Late-Line Therapy Outcomes in Recurrent Metastatic NSCLC: Monotherapy and Vinorelbine Combination RegimensYanfang Zheng(Guangzhou, China)1884PPoster Session:NSCLC, metastaticSurufatinib combined with Toripalimab, Pemetrexed, and Platinum in Advanced Non-Squamous Non-Small Cell Lung Cancer (nsg-NSCLC): Final Phase II Results from a Single-Center TrialWenfeng Fang/ Li Zhang(Guangzhou, China)1887PPoster Session: NSCLC, metastaticEfficacy/safety and preliminary scRNA-seq results of surufatinib plus gemcitabine and nab-paclitaxel as neoadjuvant therapy in resectable and borderline resectable pancreatic cancerSong Gao/ Jihui Hao(Tianjin, China)2236PPoster Session: Pancreatic cancerEfficacy and Safety of Surufatinib in Patients with Advanced Soft Tissue Sarcoma After Failure of Anthracycline Chemotherapy and Prior Effective Antiangiogenic Therapy: A Single-Arm, Prospective, Exploratory Phase II StudyXiaowei Zhang/ Zhiguo Luo (Shanghai, China)2716PPoster Session: Sarcoma 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 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 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 and savolitinib, the further clinical development for fruquintinib, surufatinib and savolitinib, its expectations as to whether any studies on fruquintinib, surufatinib and savolitinib 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 and savolitinib, 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 and savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab and toripalimab 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

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 8, 2025 /PRNewswire/ -- USA News Group News Commentary – The FDA's unprecedented wave of Breakthrough Therapy Designations through August has accelerated development timelines for life-saving cancer treatments[1], while major pharmaceutical companies deployed several multi-billion-dollar strategic partnerhips (with one topping $11 billion) to secure next-generation immunotherapies[2]. These recent designations are creating momentum for companies advancing breakthrough oncology platforms including Oncolytics Biotech Inc. (NASDAQ: ONCY), HUTCHMED (China) Limited (NASDAQ: HCM), CG Oncology, Inc. (NASDAQ: CGON), C4 Therapeutics, Inc. (NASDAQ: CCCC), and IDEAYA Biosciences, Inc. (NASDAQ: IDYA). Industry analysts expect the antibody-drug conjugate market to reach $50 billion by 2030[3], driven by 16 approved therapies and accelerating clinical pipelines. Immuno-oncology revenues jumped from $94 billion to $109.39 billion in 2025 alone[4], as leading institutions recognize the transformative potential of precision-targeted therapies and combination treatment approaches for previously untreatable cancers. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced impressive clinical data in metastatic colorectal cancer that could accelerate the company's path to registration. The latest results show pelareorep achieved a median progression-free survival of 16.6 months compared to just 5.7 months with standard treatments, representing approximately 2.5 times longer disease control in KRAS mutant colorectal cancer patients. Even more striking, overall survival reached 27.0 months versus the typical 11.2 months, representing a dramatic improvement in one of oncology's most challenging areas. This data comes from the REO 022 trial testing pelareorep with FOLFIRI and bevacizumab in second-line treatment. "These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. "Given pelareorep's activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal ("GI") tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space." The company plans to work with regulators to define a path toward registration in KRAS mutant colorectal cancer. The results extend beyond survival numbers. Translational studies confirmed pelareorep actually replicates inside tumor cells while activating immune responses, including dendritic cell maturation and CD8+ T cell activation. This proves the drug's ability to transform "cold" tumors into "hot" targets responsive to immunotherapeutic treatments. Pelareorep represents a systemically delivered oncolytic virus that reprograms the immune system against cancer. Unlike traditional chemotherapy that attacks cells indiscriminately, this immunotherapy selectively targets cancer while mobilizing the body's natural defenses. The company is simultaneously advancing toward registration-enabling trials in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), where survival data proved equally compelling. Clinical results showed a 21.9% two-year overall survival rate compared to the 9.2% historical benchmark for standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This matters because checkpoint inhibitors currently lack approval for pancreatic cancer, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumors. Oncolytics recently provided updated safety data for pelareorep, which has been administered to over 1,200 patients across multiple studies. The most common side effects remain mild flu-like symptoms, with data showing pelareorep doesn't modify the safety profile of established chemotherapy regimens. The company confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters for pancreatic cancer, targeting potential trial initiation activities by Q4 2025. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes. Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones. With survival benefits approaching 3× standard care in colorectal cancer and regulatory discussions advancing for pancreatic cancer trials by Q4 2025, Oncolytics appears positioned at a critical inflection point where proof-of-concept has evolved into potential registration-enabling studies. The company's dual-track approach in gastrointestinal cancers, combined with an experienced leadership team and FDA Fast Track designation, suggests pelareorep may soon transition from clinical promise to commercial reality. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: HUTCHMED (China) Limited (NASDAQ: HCM) highlighted clinical data from multiple oncology studies at the 2025 World Conference on Lung Cancer and CSCO Annual Meeting, showcasing updated analysis from savolitinib's SACHI, SAVANNAH and Phase IIIb confirmatory studies in non-small cell lung cancer patients. The company will present first-time clinical data of HMPL-653, a novel CSF-1R inhibitor, from a Phase I study in patients with tenosynovial giant cell tumor. Savolitinib, an oral and highly selective MET tyrosine kinase inhibitor being jointly developed with AstraZeneca, continues advancing through multiple clinical programs targeting various lung cancer indications. According to Hutchmed's announcement, updated analysis from savolitinib's SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer patients will be presented at WCLC 2025. The comprehensive clinical program spans investigator-initiated studies of fruquintinib and surufatinib across multiple cancer types, with HUTCHMED positioning itself as an innovative commercial-stage biopharmaceutical company committed to bringing targeted therapies from in-house discovery to patients worldwide. The company has successfully marketed its first three medicines in China, with its lead compound also approved globally, including in the US, Europe and Japan. CG Oncology, Inc. (NASDAQ: CGON) continues to demonstrate best-in-disease durability with its cretostimogene immunotherapy, reporting an additional 12 patients achieving complete response at 24 months in the BOND-003 Cohort C study. The robust 24-month complete response rate of 41.8% observed in 46 out of 110 patients with high-risk non-muscle invasive bladder cancer unresponsive to BCG treatment represents unprecedented durability in this heavily pretreated patient population. Notably, 90% of 12-month responders remained disease-free at 24 months, while 96.6% of patients were free from progression to muscle-invasive disease at 24 months. "Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG," said Trinity J. Bivalacqua, MD, PhD, Urologic Oncology at Penn Medicine and Co-Director, Genitourinary Cancer Service Line, Abramson Cancer Center. "In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and sustained results." The company is preparing to initiate its BLA submission for cretostimogene in the fourth quarter of 2025, with the Phase 3 BOND-003 Cohort C representing the largest study in this patient population to date. Cretostimogene's safety profile remains consistent with no Grade 3 or greater treatment-related adverse events or deaths reported, supporting its potential as a breakthrough backbone treatment for bladder cancer patients. C4 Therapeutics, Inc. (NASDAQ: CCCC) completed enrollment and dose escalation for its Phase 1 trial of cemsidomide in multiple myeloma, with the investigational MonoDAC degrader continuing to demonstrate a well-tolerated safety profile and compelling response rates. The company will present comprehensive data from all safety and efficacy evaluable multiple myeloma patients across all dose levels studied in the cemsidomide with dexamethasone cohort at the International Myeloma Society Annual Meeting on September 20, 2025. Cemsidomide is designed as a more potent and selective degrader of IKZF1/3 transcription factors that drive multiple myeloma and non-Hodgkin's lymphomas, with unique pharmacokinetic properties and demonstrated anti-myeloma activity and immunomodulatory effects. C4 Therapeutics will host an investor webcast on September 20, 2025, at 3 PM ET to highlight the data presentation and provide additional detail on the planned next steps of clinical development. The company is progressing its TORPEDO platform to efficiently design and optimize small-molecule degrader medicines targeting difficult-to-treat diseases, with cemsidomide representing a key advancement in harnessing the body's natural protein recycling system. IDEAYA Biosciences, Inc. (NASDAQ: IDYA) enrolled their first patient with non-small cell lung cancer in the ongoing Phase 1/2 combination trial of IDE397 and Trodelvy® in patients with MTAP-deletion solid tumors, expanding beyond the initial focus on MTAP-deletion urothelial cancer. IDE397, a potential first-in-class small molecule MAT2a inhibitor, is being combined with Gilead's Trop2-directed antibody-drug conjugate Trodelvy under a clinical study collaboration and supply agreement. MTAP-deletion is found in up to 20% of non-small cell lung cancer cases and represents an area with no approved targeted therapies, creating a significant opportunity for this novel therapeutic approach. "We are encouraged by the preliminary expansion data from our Phase 1/2 combination trial with IDE397 and Trodelvy in MTAP-deleted bladder cancer and excited to have dosed the first patient in the non-small cell lung cancer cohort," said Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences. "This marks an important step in our broader clinical strategy to evaluate the combination across multiple solid tumors with MTAP-deletion." IDEAYA retains commercial rights to IDE397 while Gilead provides Trodelvy supply, with the precision medicine oncology company building a deep pipeline focused on synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications. The expansion into NSCLC represents a significant milestone in the company's mission to develop tailored, potentially first-in-class targeted therapies aligned to genetic drivers of disease. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. 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Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. 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