Osimertinib mesylate

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

Bengaluru: The U.S. Food and Drug Administration said on Wednesday that it has approved Bayer's drug for patients with a form of lung cancer that has advanced or spread despite earlier treatments. The drug, branded as Hyrnuo, is approved for non-squamous non-small cell lung cancer (NSCLC) in patients with mutations affecting the HER2 protein, which plays a crucial role in regulating cell growth and development, as identified by an FDA-approved test. Bayer's oral drug belongs to a class of drugs known as kinase inhibitors, which block the action of protein kinases that regulate cell growth. The monthly list price for Hyrnuo is $24,000. Approval of Bayer's drug also heats up competition with privately held Boehringer Ingelheim's Hernexeos, another kinase inhibitor, approved in August for a challenging form of lung cancer. Hyrnuo's approval "provides a welcome addition to the treatment space," said Bayer executive Chandrasekhar Goda. In studies, 71% of the 70 patients who received Hyrnuo, after previous cancer treatments but not those targeting the HER2 mutation, saw their tumors shrink or disappear. In another group of 52 patients who had prior systemic therapy, including HER2-targeting treatments, Bayer's drug helped shrink tumors in 38% of them. NSCLC is the most common type of lung cancer, with about 80% to 85% of all cases. Antibody-drug conjugates such as AbbVie's Emrelis are also approved for a type of NSCLC. The class of therapies acts as "guided missiles" that target only cancer cells while sparing healthy cells, unlike conventional chemotherapy. Other treatment options for NSCLC include Merck's blockbuster Keytruda and AstraZeneca's Tagrisso. FDA also approved the Life Technologies Corporation's test as a companion diagnostic device to help detect the mutations in patients who may be eligible for Bayer's drug. (Reporting by Sriparna Roy in Bengaluru; Editing by Alan Barona, Vijay Kishore and Sherry Jacob-Phillips)>