SAN CARLOS, Calif.–(BUSINESS WIRE<\/a>)–BeOne Medicines Ltd.<\/a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from multiple differentiated investigational medicines across its priority solid tumor disease areas at the European Society for Medical Oncology (ESMO) Congress 2026 (October 23\u201327, Madrid). The presentations span gastrointestinal, lung, and breast cancers, and reflect the growing momentum of BeOne\u2019s solid tumor franchise.<\/p>\n Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said:<\/b><\/p>\n \n\u201cAt ESMO, we are showing how our strategy of matching the right modality to disease biology is translating into meaningful clinical progress. Our GPC3 x 4-1BB bispecific antibody continues to be well tolerated and demonstrates durable activity with longer follow up in patients with heavily pre-treated hepatocellular carcinoma, while the first clinical data from our brain-penetrant PRMT5 inhibitor and CEA-targeting ADC expand our innovation in non-small cell lung cancer. Alongside the global Phase 3 KANDELA-302 study of our CDK4 inhibitor in breast cancer, these advances mark a clear step forward as BeOne\u2019s solid tumor pipeline moves from promising science toward medicines with the potential to improve outcomes in difficult-to-treat cancers.\u201d<\/p>\n Potential first-in-class GPC3\u00d74-1BB bispecific continues to demonstrate compelling and durable activity in heavily pretreated HCC (Proffered Paper: 1679O; October 24, 10:15\u201311:45 CET)<\/b><\/p>\n \nPatients with advanced HCC who progress after immunotherapy face a high unmet need, with no established standard of care and five-year survival of only approximately 20%1,2<\/sup>. BGB-B2033 is an investigational bispecific antibody designed to address this gap by activating 4-1BB on T cells in the presence of GPC3-expressing tumor cells, concentrating immune activation at the tumor site, and limiting systemic toxicity, a key consideration for HCC patients who frequently suffer from underlying liver disease.<\/p>\n \nUpdated Phase 1 results include the first disclosure of dose-optimization data and longer follow-up from dose escalation. Among 94 patients, 93.6% had received prior PD-(L)1 therapy and 61.7% had received both PD-(L)1 therapy and a tyrosine kinase inhibitor (TKI). Highlights include:<\/p>\n \nBGB-B2033 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in December 2025, as well as Orphan Drug Designation from the FDA in March 2026 and the European Commission in October 2026 for hepatocellular carcinoma (HCC). BeOne plans to initiate global registrational clinical trials in late-line HCC by the end of 2026, while also developing plans for registrational studies in earlier treatment settings.<\/p>\n Initial first-in-human data from two differentiated assets advance BeOne\u2019s emerging NSCLC portfolio<\/b><\/p>\n \nAt ESMO 2026, BeOne is presenting initial clinical data in NSCLC from two biomarker-led programs with distinct mechanisms: the oral, brain-penetrant PRMT5 inhibitor, BGB-58067, and the CEA-targeting antibody-drug conjugate (ADC), BG-C477. Based on these promising data, both programs are intended to advance toward late-stage development in 2027, continuing to build BeOne\u2019s footprint in lung cancer alongside its established program with TEVIMBRA (tislelizumab).<\/p>\n Brain-penetrant PRMT5 inhibitor, BGB-58067, demonstrates systemic and intracranial activity in MTAP-deficient NSCLC (Poster: 1043P; October 23, 3:15\u20134:00 PM CET)<\/b><\/p>\n \nBGB-58067 is a highly potent, brain-penetrant methylthioadenosine (MTA)-cooperative PRMT5 inhibitor designed to exploit the vulnerability created by MTAP deficiency. In this, the largest publicly shared data set in MTAP-deficient solid tumors, initial Phase 1 findings from 182 patients, including 83 with NSCLC, showed:<\/p>\n CEA-targeting ADC BG-C477 achieves encouraging response rate in previously-treated CEAhigh<\/sup> NSCLC (Poster: 2567P; October 26, 12:00\u201312:45 PM CET)<\/b><\/p>\n \nBG-C477 is the first ADC to emerge from BeOne\u2019s internal drug discovery organization. With a proprietary CEA (or CEACAM5) targeting antibody, a highly stable conjugator, and a cleavable linker, BG-C477 is designed to deliver a potent topoisomerase I inhibitor payload directly to CEA-expressing tumor cells.<\/p>\n \nAs of April 9, 2026, preliminary Phase 1 monotherapy findings from 43 heavily pretreated patients with NSCLC, including 25 with high CEA expression, showed:<\/p>\n \nUpdated results, with a more recent data cut-off, will be presented in the Locally Advanced NSCLC poster session on Monday, October 26 at 12:00 CET. BG-C477 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in October 2026.<\/p>\n Pivotal-study update: Phase 3 KANDELA-302 trial of CDK4 inhibitor BGB-43395 now enrolling in first-line HR+\/HER2-negative breast cancer (1885TiP; October 24, 12:00\u201312:45 PM CEST)<\/b><\/p>\n \nBuilding on previously reported Phase 1 activity and tolerability findings, BeOne is advancing BGB-43395, an investigational selective CDK4 inhibitor, in the global Phase 3 KANDELA-302 study (NCT07492641<\/a>). The study compares BGB-43395 plus letrozole with investigator\u2019s choice of abemaciclib, palbociclib or ribociclib plus letrozole in first-line HR+\/HER2-negative advanced or metastatic breast cancer.<\/p>\n \nEnrollment began in May 2026, with patients planned across North and South America, Europe, Asia and Australia. The primary endpoint is progression-free survival by blinded independent central review, with overall survival as the key secondary endpoint.<\/p>\n About BGB-B2033 About BGB-58067 About BG-C477 About BGB-43395 About BeOne Forward-Looking Statement \nTo access BeOne media resources, please visit ourNewsroom<\/b><\/a>site.<\/p>\n\n
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<\/b>BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in HCC4<\/sup>, and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.5<\/sup> The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity.<\/p>\n
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<\/b>BGB-58067 is an investigational, oral small molecule designed to inhibit protein arginine methyltransferase 5 (PRMT5) in an MTA-dependent manner, enabling selective targeting of MTAP-deleted cancer cells. Preclinical data demonstrate enhanced selectivity compared with MTAP wild-type cells, as well as strong potency and brain penetration.<\/p>\n
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<\/b>BG-C477 is an investigational ADC designed to target CEA, also known as CEACAM5, a protein highly expressed in several epithelial cancers, including certain lung and gastrointestinal cancers. The molecule is designed to work as a targeted delivery system, using an antibody that specifically recognizes CEA to deliver a potent anti-cancer payload to CEA-expressing tumor cells. BG-C477 incorporates a highly stable conjugator and cleavable linker, aiming for a strong bystander effect and manageable toxicity.<\/p>\n
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<\/b>BGB-43395 is an investigational cyclin-dependent kinase (CDK) 4 inhibitor being studied in a global clinical development program that includes the KANDELA-302 (NCT07492641<\/a>) Phase 3 clinical trial, in hormone receptor-positive (HR+)\/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. BGB-43395 is a highly potent and selective CDK4 inhibitor that may reduce dose-limiting hematologic toxicities associated with the current CDK4\/6 standard of care and improve tolerability, thereby enabling deeper CDK4 inhibition.<\/p>\n
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<\/b>BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com<\/a> and follow us on LinkedIn<\/a>, X<\/a>, Facebook<\/a> and Instagram<\/a>.<\/p>\n
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<\/b>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential of BGB-B2033, BGB-58067, BG-C477 and BGB-43395 to improve outcomes for patients; BeOne\u2019s plans to initiate global registrational clinical trials of BGB-B2033 in late-line HCC by the end of 2026 and to develop registrational studies in earlier treatment settings; the expected advancement of BGB-58067 and BG-C477 toward late-stage development in 2027;<\/span> the conduct and enrollment of the KANDELA-302 study; and BeOne\u2019s plans, commitments, aspirations, and goals under the heading \u201cAbout BeOne.\u201d Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne\u2019s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled \u201cRisk Factors\u201d in BeOne\u2019s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.<\/p>\n