Obinutuzumab

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that more than 60 abstracts across hematologic malignancies and solid tumors have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29–June 2, Chicago) and the 2026 European Hematology Association (EHA) Congress (June 11–14, Stockholm). Continuing to raise the bar in CLL At ASCO and EHA 2026, BeOne will showcase its hematology leadership with data spanning foundational therapies and next-generation innovation across CLL, mantle cell lymphoma and other B-cell malignancies. The data emphasize impressive long-term outcomes, durability across patient populations, and a disciplined approach to advancing future regimens. Collectively, these data underscore BeOne’s strategy to lead in hematology science and patient impact by setting the standard today – while helping to shape the future of CLL. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said: “Seventy-eight-month follow-up data from SEQUOIA underscore what it truly takes to lead in CLL over the long term: long-term efficacy, ability for sequencing treatments, and confidence in first-line treatment decisions. Building on that leadership, we’re excited to be rapidly advancing the next generation of medicines, including sonrotoclax-based combinations and our BTK degrader BGB-16673, which are designed to extend what is possible for patients across lines of therapy.” Key data presentations in CLL include: New results from the SEQUOIA trial with 78 months follow-up reinforce BRUKINSA ® (zanubrutinib) as the foundational BTK inhibitor in CLL, with durable disease control that continues to raise expectations for what patients and physicians should expect from first-line therapy over the long term. Data will be presented at both ASCO and EHA. A subgroup analysis of SEQUOIA, which includes one of the largest and longest-followed cohorts of patients aged ≥80 years ever reported in a Phase 3 CLL study , showing that age did not limit benefit. Data will be presented at EHA 2026. Oral presentation at EHA 2026 of updated data of BeOne’s foundational BTK degrader – BGB-16673 – in patients with R/R CLL , demonstrating promising and durable activity and a manageable safety profile. An additional poster will be shared featuring never-before-presented data of BGB-16673 in BTK-naïve patients. BGB-16673 is the most advanced BTK degrader in the clinic, with more than 1,100 patients dosed. Data from the all-oral combination of BeOne’s foundational BCL2 inhibitor sonrotoclax plus zanubrutinib (ZS) in CLL , which demonstrated deep responses, unprecedented speed to undetectable MRD, and durable remissions and a generally well-tolerated safety profile. These data reinforce the potential for a next-generation, time-limited approach designed to deliver long-term outcomes without compromising durability or safety. Data will be presented as a poster at ASCO 2026 and an oral presentation at EHA 2026. Accelerating a high-potential solid tumor portfolio BeOne is highlighting strong momentum across its deep and diverse solid tumor portfolio at ASCO, with seven unique assets featured in three oral presentations and eight posters. These data span both in-line and pipeline therapies, including results demonstrating the differentiated profile of PD-1 inhibitor TEVIMBRA® (tislelizumab) across lung and gastrointestinal cancers, as well as in combination with the novel HER2-targeting agent ZIIHERA® (zanidatamab). The Company’s development superhighway is accelerating progress across all stages of development, generating compelling clinical data that support the potential of these therapies to reshape treatment in areas of high unmet need. Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said: “At ASCO 2026, we are demonstrating the strength of BeOne’s science, the scale of our pipeline, and the speed at which we are delivering innovation for patients. With multiple programs moving simultaneously toward pivotal trials, we are building durable disease leadership across breast, gynecologic, lung and gastrointestinal cancers – areas where substantial unmet patient need remains.” Key data presentations across our solid tumor programs include: First disclosure of anti-tumor effects and safety/tolerability profile of the highly selective CDK4 inhibitor BGB-43395 Phase 1 treatment data in first-line HR-positive/HER2-negative breast cancer. Rapid oral presentation on BG-C9074, a promising B7-H4-targeting ADC, with Phase 1 dose escalation and safety expansion data. Rapid oral presentation on BGB-B2033, a potentially first-in-class GPC3 x 4-1BB bispecific antibody , with first clinical data of a Phase 1 study in heavily pre-treated hepatocellular carcinoma patients. Rapid oral presentation with a PD-L1 subgroup analysis of the HERIZON-GEA-01 trial in which TEVIMBRA in combination with ZIIHERA and chemotherapy demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in patients with HER2+ gastroesophageal adenocarcinoma, irrespective of PD-L1 expression (in partnership with Jazz Pharmaceuticals). Investor webcast to highlight pipeline data at ASCO BeOne will host an investor webcast on June 1, 2026, at 7:00 PM CDT/8:00 PM EDT, led by John V. Oyler, Co-Founder, Chairman, and CEO, alongside the Company’s leadership team and invited key opinion leaders. The webcast will review clinical and corporate highlights from ASCO, provide updates on BeOne’s global R&D pipeline and platforms, and discuss the strategic priorities and execution capabilities driving the Company’s long-term growth. Webcast access details are available in the Investors section of BeOne’s website at http://ir.beonemedicines.com, https://hkexir.beonemedicines.com, and https://sseir.beonemedicines.com. An archived webcast will be available on the Company’s website. Full list of BeOne’s presentations at ASCO: Hematology BRUKINSA® (Zanubrutinib) Abstract Title Presentation Details Lead Author Subsequent therapies and time to second progression-free survival events in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with zanubrutinib or bendamustine-rituximab in SEQUOIA Poster Presentation: 544 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Constantine S. Tam Navigating the post–covalent Bruton tyrosine kinase inhibitor landscape in mantle cell lymphoma: Real-world insights on treatment patterns, discontinuation, and healthcare resource utilization Poster Presentation: 556 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Alvaro Alencar Real-world outcomes among Medicare beneficiaries treated with first-line Bruton tyrosine kinase inhibitors for chronic lymphocytic leukemia Poster Presentation: 545 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Daniel A. Ermann Real-world impact of atrial fibrillation on cardiovascular outcomes and healthcare resource utilization in patients with chronic lymphocytic leukemia Poster Presentation: 540 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Michael Fradley Real-world treatment survival outcomes for zanubrutinib and acalabrutinib monotherapy among treatment-naïve patients with chronic lymphocytic leukemia in the United States Poster Presentation: 543 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Ryan Jacobs A real-world comparison of treatment and survival outcomes with zanubrutinib and acalabrutinib monotherapy among patients with relapsed or refractory mantle cell lymphoma in the United States Poster Presentation: 560 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Yucai Wang Incidence of cardiac-related deaths among patients aged ≥65 years with B-cell malignancies treated with ibrutinib Abstract Number: e19020 Ryan Jacobs Risk factors for second primary malignancies in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: A real-world study Abstract Number: e19022 Lili Zhou Characterizing patient self-reported adherence to BTKis and symptoms in CLL/SLL using an electronic patient-reported outcomes platform Abstract Number: e19030 Mustafa Ascha Real-world treatment utilization, sequencing patterns, and healthcare resource utilization in Waldenström macroglobulinemia Abstract Number: e19056 Jorge Castillo Sonrotoclax Abstract Title Presentation Details Lead Author First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetectable minimal residual disease rates of >90%, including in patients with del(17p)/TP53 Poster Presentation: 541 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Constantine S. Tam Sonrotoclax + zanubrutinib vs venetoclax + acalabrutinib in treatment-naive chronic lymphocytic leukemia: A phase 3 randomized trial design (CELESTIAL-TNCLL-2) Poster Presentation: 596a Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Mazyar Shadman Efficacy of sonrotoclax vs pirtobrutinib in post–Bruton tyrosine kinase inhibitor relapsed/refractory mantle cell lymphoma: An indirect comparison Abstract Number: e19050 Alvaro Alencar Solid Tumors BGB-43395 (CDK4i) Abstract Title Presentation Details Lead Author First disclosure of frontline treatment with the selective CDK4 inhibitor BGB-43395 in combination with letrozole for metastatic HR+/HER2− breast cancer: A phase 1 safety expansion Poster Session: 180 Session Title: Poster Session - Breast Cancer - Metastatic Session Date/Time: June 1, 2026, 1:30-4:30 PM CDT Shom Goel BG-C9074 (B7-H4-targeting ADC) Abstract Title Presentation Details Lead Author First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion Rapid Oral Abstract: 3013 Session Title: Rapid Oral Abstract Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology Session Date/Time: June 2, 2026, 9:45-11:15 AM CDT Binghe Xu Consideration of adjusted ideal body weight dosing in BG-C9074 (B7-H4-targeting ADC) from pharmacokinetics, efficacy and safety perspectives Poster Session: 166 Session Title: Poster Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology Session Date/Time: May 30, 2026, 1:30-4:30 PM CDT Hugh Giovinazzo BGB-B2033 (GPC3x4-1BB bispecific antibody) Abstract Title Presentation Details Lead Author A phase 1 study of BGB-B2033 (GPC3 x 4-1BB bispecific antibody) monotherapy in patients with selected advanced or metastatic solid tumors: First disclosure of clinical data Rapid Oral Abstract: 3016 Session Title: Rapid Oral Abstract Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology Session Date/Time: June 2, 2026, 9:45-11:15 AM CDT Hong Jae Chon TEVIMBRA® (tislelizumab) and ZIIHERA® (zanidatamab) Abstract Title Presentation Details Lead Author Zanidatamab + chemotherapy ± tislelizumab for first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma: PD-L1 subgroup analysis from HERIZON-GEA-01 Rapid Oral Abstract: 4010 Session Title: Rapid Oral Abstract Session – Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary Session Date/Time: June 1, 2026, 1:15-2:45 PM CDT SunYoung Rha Characterization and management of gastrointestinal adverse events with zanidatamab + chemotherapy ± tislelizumab in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma: Analysis from HERIZON-GEA-01 Poster Presentation: 25 Session Title: Poster Session – Gastrointestinal Cancer- Gastroesophageal, Pancreatic, and Hepatobiliary Session Date/Time: May 30, 2026, 9 AM-12:00 PM CDT Elena Elimova TEVIMBRA® (tislelizumab) Abstract Title Presentation Details Lead Author RATIONALE-315: Post hoc analysis of event-free survival by surgically relevant subgroups treated with perioperative tislelizumab and neoadjuvant chemotherapy vs neoadjuvant chemotherapy Poster Presentation: 533 Session Title: Poster Session - Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Session Date/Time: May 31, 2026, 9:00 AM-12:00 PM CDT Gustavo Schvartsman Quality-adjusted survival comparison for tislelizumab + chemotherapy (CT) versus placebo + CT as first-line treatment in gastric/gastroesophageal junction adenocarcinoma patients with peritoneal metastasis: Long-term follow-up from RATIONALE-305 Poster Presentation: 17 Session Title: Poster Session - Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Session Date/Time: May 30, 2026, 9:00 AM-12:00 PM CDT Rutika Mehta A novel Bayesian approach for assessing associations between ECOG performance status and patient-reported outcomes in patients with gastric or gastroesophageal junction adenocarcinoma: Post hoc analysis from the RATIONALE-305 trial Abstract Number: e16044 Marcia Cruz-Correa Ociperlimab Abstract Title Presentation Details Lead Author Exploratory biomarker analysis of ociperlimab plus tislelizumab in patients with PD-L1-positive non-small cell lung cancer in AdvanTIG-105 Poster Session: 361 Session Title: Poster Session - Developmental Therapeutics - Immunotherapy Session Date/Time: May 30, 2026, 1:30-4:30 PM CDT Jun Zhang BGB-A3055 (anti-CCR8) Abstract Title Presentation Details Lead Author A phase 1 study of BGB-A3055 (anti-CCR8) with or without tislelizumab (anti-PD-1) in patients with solid tumors Poster Session: 313 Session Title: Poster Session - Developmental Therapeutics - Immunotherapy Session Date/Time: May 30, 2026, 1:30 PM-4:30 PM CDT Judith Raimbourg Full list of BeOne’s presentations at EHA: Zanubrutinib Abstract Title Presentation Details Lead Author Long-term follow-up for safety and efficacy of zanubrutinib in elderly (≥80 years) treatment naïve CLL/SLL patients, including those with del(17p): Subgroup analysis from the SEQUOIA trial Publication Number: PS1703 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Alessandra Tedeschi Subsequent therapies and time to second progression-free survival events in chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with zanubrutinib or bendamustine-rituximab Publication Number: PF601 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Mazyar Shadman Zanubrutinib vs ibrutinib in treatment-naive chronic lymphocytic leukemia (CLL): Implications for interpreting fixed-duration treatment outcomes from CLL17 Publication Number: PS1718 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Talha Munir Associations between ECOG performance status and patient-reported outcomes in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: Post hoc analysis from the ALPINE trial Publication Number: PS2492 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Nicole Lamanna A longitudinal analysis of patients with CLL/SLL with impaired health-related quality of life scores at baseline who were treated with zanubrutinib versus ibrutinib: A post hoc analysis of ALPINE Publication Number: PF1398 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Loic Ysebaert Real-world zanubrutinib treatment patterns in CLL/SLL among US community oncology patients with prior acalabrutinib therapy Publication Number: PF618 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Jing-Zhou Hou Patterns of treatment utilization and sequencing across lines of therapy in Waldenström macroglobulinemia: Real-world evidence from the United States Publication Number: PS2516 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Prashant Kapoor Real-world comparative analysis of treatment discontinuation with covalent Bruton tyrosine kinase inhibitors in first-line chronic lymphocytic leukemia Publication Number: PS1710 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Nakhle Saba Real-world treatment and survival outcomes for zanubrutinib and acalabrutinib monotherapy among treatment-naïve patients with chronic lymphocytic leukemia in the United States Publication Number: PF608 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Ryan Jacobs A real-world comparison of treatment and survival outcomes with zanubrutinib and acalabrutinib monotherapy among patients with relapsed or refractory mantle cell lymphoma in the United States Publication Number: PS2040 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Yucai Wang Clinical outcomes among patients with relapsed/refractory mantle cell lymphoma receiving zanubrutinib or acalabrutinib in real-world practice in the United States Publication Number: PF958 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Javier Munoz Real-world impact of atrial fibrillation on cardiovascular outcomes and healthcare resource utilization in patients with chronic lymphocytic leukemia Publication Number: PS2515 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Rhys Williams Treatment burden among patients aged 75 or older with chronic lymphocytic leukemia and small lymphocytic lymphoma Publication Number: PF605 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Daniel Ermann Real-world effectiveness and safety of zanubrutinib in Waldenström macroglobulinemia: Results from the Belgian WIZARD study Abstract Number: PB3600 Willem Daneels Real-world experience with zanubrutinib in chronic lymphocytic leukaemia - patient profile, treatment patterns, and safety: Preliminary analysis of French ROZALY study Abstract Number: PB2898 Florian Bouclet BRUMIZE: Real-world zanubrutinib use and preliminary safety in R/R marginal zone lymphoma in Europe Abstract Number: PB3632 Côme Bommier Indirect comparison of zanubrutinib vs acalabrutinib and ibrutinib efficacy in patients with treatment-naïve chronic lymphocytic leukemia Abstract Number: PB2895 Mazyar Shadman Patient-reported outcomes and disease progression in chronic lymphocytic leukemia and small lymphocytic lymphoma: A systematic literature review and gap analysis Abstract Number: PB2909 Loic Ysebaert Understanding patients' perspectives and preferences regarding first-line chronic lymphocytic leukemia treatment across Europe Abstract Number: PB2934 Lydia Scarfò Number of deaths avoided with use of zanubrutinib versus ibrutinib for the treatment of chronic lymphocytic leukemia in Europe Abstract Number: PB2944 Talha Munir Real-world intravenous immunoglobulin utilization in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma treated with venetoclax plus obinutuzumab vs zanubrutinib Abstract Number: PB2915 Nicole Lamanna Real-world outcomes among Medicare beneficiaries treated with first-line Bruton tyrosine kinase inhibitors for chronic lymphocytic leukemia Abstract Number: PB2901 Daniel A. Ermann Exploring the patient and hematologist preference of treatment characteristics for chronic lymphocytic leukemia: A qualitative study in Europe Abstract Number: PB4474 Lydia Scarfò Sonrotoclax Abstract Title Presentation Details Lead Author First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetectable minimal residual disease rates of >90%, including in patients with del(17p)/TP53 Publication Number: S145 Session: s424 Prognostication and first line therapy in CLL Session Date/Time: June 12, 2026 17:15 - 18:30 CEST Chan Y. Cheah Updated safety and efficacy of all-oral sonrotoclax + zanubrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, including patients with del(17p)/TP53 Publication Number: PS1697 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Stephen S. Opat Combination treatment with novel BCL2 inhibitor sonrotoclax (BGB-11417) and zanubrutinib in patients with relapsed/refractory mantle cell lymphoma: Results from a phase 1/1b study Publication Number: PF933 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Jacob D. Soumerai Phase 1/2 study of sonrotoclax (BGB-11417) monotherapy in Bruton tyrosine kinase inhibitor–pretreated relapsed/refractory mantle cell lymphoma: A Chinese subpopulation analysis Publication Number: PF961 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Yuqin Song Sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + acalabrutinib in treatment-naive chronic lymphocytic leukemia: A phase 3 randomized trial design (CELESTIAL-TNCLL-2) Abstract Number: PB2966 Mazyar Shadman Efficacy of sonrotoclax versus pirtobrutinib in post–Bruton tyrosine kinase inhibitor relapsed/refractory mantle cell lymphoma: An indirect comparison Abstract Number: PB3626 Toby A. Eyre Navigating the post–covalent Bruton tyrosine kinase inhibitor landscape in mantle cell lymphoma: Real-world insights on treatment patterns, discontinuation, and healthcare resource utilization Abstract Number: PB3617 Toby A. Eyre Risk of tumor lysis syndrome among venetoclax-treated patients with chronic lymphocytic leukemia or mantle cell lymphoma: A real-world study Abstract Number: PB2896 Alessandra Ferrajoli BGB-16673 Abstract Title Presentation Details Lead Author BGB-16673, a Bruton tyrosine kinase degrader, in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: A phase 1 CaDAnCe-101 study update Publication Number: S152 Session: s449 Novel therapies in relapsed/refractory CLL Session Date/Time: June 14, 2026 11:00 - 12:15 CEST Stephan Stilgenbauer Bruton tyrosine kinase (BTK) degrader BGB-16673 in BTK inhibitor–naive patients with CLL/SLL and other B-cell malignancies: Results from the phase 1 CaDAnCe-101 study Publication Number: PS1693 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Irina Mocanu BGB-16673, a Bruton tyrosine kinase degrader, in patients with relapsed/refractory Waldenström macroglobulinemia: A phase 1 CaDAnCe-101 study update Publication Number: PS2033 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Judith Trotman BGB-16673, a Bruton tyrosine kinase degrader, has low risk of CYP3A-mediated drug-drug interaction (DDI): Phase 1 absorption, distribution, metabolism, and excretion and DDI study results Publication Number: PS1711 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Judith Trotman BGB-16673 versus idelalisib + rituximab (R), bendamustine + R, or venetoclax + R re-treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: The phase 3 CaDAnCe-302 trial Abstract Number: PB2925 Paolo Ghia Tislelizumab Abstract Title Presentation Details Lead Author Evaluation of PET-CT metrics and pharmacokinetics in adults receiving tislelizumab for relapsed/refractory classical Hodgkin lymphoma: Ancillary analyses of LYSA phase 2 TIRHOL study BGB-A317-210 Publication Number: PS2028 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Hervé Ghesquières About BRUKINSA® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. With the broadest label globally, BRUKINSA is the foundational BTK inhibitor. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing and the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally. About BEQALZI™ (sonrotoclax) BEQALZI™ (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. BEQALZI has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program. About BGB-16673 BGB-16673 is a foundational and potential first-in-class and best-in-class Bruton’s tyrosine kinase (BTK) degrader for the treatment of B-cell malignancies. With 1,100+ patients dosed to date in an extensive global clinical development program, BGB-16673 is the most advanced BTK degrader in the clinic. This program includes three randomized Phase 3 trials in R/R CLL, including the head-to-head Phase 3 trial versus pirtobrutinib, which began enrolling in Q4 2025. Originating from BeOne’s chimeric degradation activation compound (CDAC) platform, BGB-16673 is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). Additionally, the European Medicines Agency (EMA) granted BGB-16673 PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor. About ZIIHERA (zanidatamab) ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions. ZIIHERA is a registered trademark of Zymeworks BC Inc. About TEVIMBRA (tislelizumab) TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved in over 50 countries, and more than 2 million patients have been treated globally. Select Important Safety Information for BRUKINSA® (zanubrutinib) Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury). In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Please see full U.S. Prescribing Information including U.S. Patient Information. Select Important Safety Information for BEQALZITM (sonrotoclax) Serious and sometimes fatal adverse reactions have occurred with BEQALZI, including tumor lysis syndrome (TLS), serious infections, neutropenia, and embryo-fetal toxicity. BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome. In the safety population (N=115), tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up. Serious infections occurred in 14% of patients, and Grade 3 or 4 infections occurred in 17% (fatal: 2.6%), with pneumonia (10%) being the most common Grade 3 or greater infection. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%), and febrile neutropenia occurred in 1.7% of all patients. The most common adverse reactions (≥15%) were pneumonia (16%) and fatigue (16%). The most common Grade 3–4 laboratory abnormalities (≥15%) were decreases in lymphocytes (29%) and neutrophils (18%). Please see full Prescribing Information. Select Important Safety Information for TEVIMBRA Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity. Please see full U.S. Prescribing Information including the U.S. Medication Guide. The information provided in this press release is intended for a global audience. Product indications vary by region. About BeOne 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 and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement 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 BeOne’s ability to advance future regiments and lead in hematology; BeOne’s ability to build durable disease area leadership in solid tumors; BeOne’s clinical development plans for various programs; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” 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’s 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 “Risk Factors” in BeOne’s 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. To access BeOne media resources, please visit our Newsroom site. ____________________ 1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.).