BeOne Medicines Sets the Pace in Oncology at ASCO and EHA 2026 with 60+ Abstracts

Long-term and real-world evidence reinforce BRUKINSA as the foundation of CLL treatment

Three oral presentations at ASCO highlight rapid acceleration of BeOne’s solid tumor pipeline

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)

Sonrotoclax

Solid Tumors

BGB-43395 (CDK4i)

BG-C9074 (B7-H4-targeting ADC)

BGB-B2033 (GPC3x4-1BB bispecific antibody)

TEVIMBRA^® (tislelizumab) and ZIIHERA^® (zanidatamab)

TEVIMBRA^® (tislelizumab)

Ociperlimab

BGB-A3055 (anti-CCR8)

Full list of BeOne’s presentations at EHA:

Zanubrutinib

Sonrotoclax

BGB-16673

Tislelizumab

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 BEQALZI^TM (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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260521195975/en/

Investor Contact
Liza Heapes
+1 857-302-5663
ir@beonemed.com

Media Contact
Kyle Blankenship
+1 667-351-5176
media@beonemed.com

Source: BeOne Medicines Ltd.