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Last update 03 Jun 2026
BGB-B2033
Last update 03 Jun 2026
Overview
Basic Info
Drug Type Bispecific antibody |
Synonyms GPC3 x 4-1BB BsAb (BeiGene), BGB B2033, BGB-B2033 + [1] |
Target |
Action agonists, inhibitors |
Mechanism 4-1BB agonists(Tumor necrosis factor receptor superfamily member 9 agonists), GPC3 inhibitors(Glypican-3 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 1 |
First Approval Date- |
RegulationOrphan Drug (United States), Fast Track (United States) |
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Related
1
Clinical Trials associated with BGB-B2033NCT06427941
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors
This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors/non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC).
Start Date23 Jul 2024 |
Sponsor / Collaborator |
100 Clinical Results associated with BGB-B2033
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100 Translational Medicine associated with BGB-B2033
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100 Patents (Medical) associated with BGB-B2033
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8
News (Medical) associated with BGB-B203301 Jun 2026
Oral and poster presentations span three priority programs in breast, gynecologic, and gastrointestinal cancers, advancing rapidly toward pivotal development
Company to host investor webcast showcasing momentum across solid tumor pipeline
SAN CARLOS, Calif.--(BUSINESS WIRE)--
$ONC
#BeOne
--
BeOne Medicines Ltd.
(“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from its solid tumor pipeline being presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29–June 2, Chicago). These data underscore the significant acceleration across the Company’s high-priority breast, gynecologic and gastrointestinal (GI) cancer development programs.
Data from three differentiated BeOne pipeline assets will be presented, including:
CDK4 inhibitor (BGB-43395)
(poster presentation): First disclosure of anti-tumor activity in first-line (1L) HR+/HER2- metastatic breast cancer.
B7-H4 ADC (BG‑C9074)
(rapid oral presentation): Phase 1 dose-escalation and safety expansion data in advanced solid tumors.
GPC3x4-1BB (BGB-B2033)
bispecific antibody
(rapid oral presentation): First clinical data in advanced solid tumors, including hepatocellular carcinoma (HCC), the most common type of liver cancer.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said:
“2026 is an inflection year for BeOne’s solid tumor portfolio, marked by the encouraging data we are presenting at ASCO combined with upcoming readouts at other major congresses. These programs validate our strategy of pairing the right biology with the right modality, and support advancing several assets in different indications into pivotal trials in 2026.”
Selective CDK4 inhibitor shows promising efficacy and differentiated safety in first-line breast cancer (Poster Presentation: 180; June 1, 2026, 1:30 PM-4:30 PM CDT)
BeOne will present data about its highly selective CDK4 inhibitor, BGB-43395, in 1L HR+/HER2- metastatic breast cancer, in combination with letrozole, showing promising anti-tumor activity and a favorable safety profile, characterized by infrequent low-grade hematologic toxicities and manageable GI events, which were further mitigated when administered with food. Highlights include:
The 240 mg dose of BGB-43395 plus letrozole resulted in a confirmed overall response rate (ORR) of 68.4% (95% CI: 43.4–87.4) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9).
The 400 mg dose plus letrozole resulted in a confirmed ORR of 63.2% (95% CI: 38.4–83.7) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9).
Low levels of hematologic treatment-related adverse events (TRAEs) with Grade ≥3 neutropenia reported in 5.3% of patients at the 240 mg dose level and 0% at 400 mg, as well as low frequency of fatigue and asthenia; supports pro validates the molecule’s high selectivity for CDK4.
GI TRAEs were mitigated when administered with food, all of which were Grade 1.
Median study follow-up was 12.5 (range, 3.1-15.2) months, 12.4 (range, 8.0-15.0) months, and 10.8 (range, 3.2-12.9) months for the 240 mg, 400 mg, and 600 mg dose groups, respectively.
These compelling safety and efficacy findings support the rationale to initiate a global, randomized Phase 3 clinical trial with BGB-43395 in combination with letrozole in 1L HR+/HER2- metastatic breast cancer. The trial, KANDELA-302 (
NCT07492641
), will begin enrolling patients this month.
B7-H4 ADC demonstrates encouraging efficacy supporting advancement in ovarian cancer (Rapid Oral Abstract: 3013; June 2, 2026, 9:45-11:15 AM CDT)
Data at ASCO from BeOne’s B7‑H4-targeting antibody-drug conjugate (ADC), BG‑C9074, include results from Phase 1 dose‑escalation and safety‑expansion cohorts, demonstrating a combination of early efficacy signals and a favorable tolerability profile. Highlights include:
At doses under consideration for future development, confirmed ORR of 45.5% and unconfirmed ORR of 54.5% in ovarian cancer (OC), and 40.0% in triple-negative breast cancer, with median study follow-up of 6.6 (range, 0.3-20.8) months.
Anti-tumor activity demonstrated in OC regardless of B7-H4 expression level.
Treatment was generally well tolerated with low rates of discontinuation at 5% of patients were limited to increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST), both occurring at Grade ≥3 in only 1.6% of patients.
BGB-B2033
300 mg Q3W
(N=14)
600 mg Q3W
(N=14)
1000 mg Q3W
(N=10)
Confirmed ORR (complete response + partial response), n (%)
4 (28.6)
5 (35.7)
2 (20.0)
Unconfirmed ORR (complete response + partial response), n (%)
4 (28.6)
5 (35.7)
3 (30.0)*
*An additional PR (week 36) was reported at 1000 mg, with patient still on treatment, pending confirmation in the next tumor assessment
With ORR levels in heavily pretreated patients on par with the current first-line immunotherapy combination standard of care and a differentiated safety profile, BeOne is moving rapidly to advance clinical development of BGB-B2033. The Company has already announced the initiation of a potentially registration-enabling pivotal study in late-line HCC and planned expansion into earlier lines of therapy and additional tumor types, with the ambition to establish a new standard of care in this difficult-to-treat cancer.
Investor webcast to highlight solid tumor pipeline data at ASCO
BeOne will hold an investor webcast at 7:00 p.m. CDT/8:00 p.m. EDT, today, June 1, 2026. The Company’s leadership team, with clinical commentary by expert physicians, will highlight key solid tumor programs being presented at ASCO, share progress in BeOne’s global R&D portfolio, and outline the strategies and capabilities supporting the Company’s continued growth trajectory.
Webcast access details are available in the Investors section of BeOne’s website at
,
, and
. An archived webcast will be available on the Company’s website.
About BGB-43395, a CDK4 inhibitor
BGB-43395 is an investigational cyclin-dependent kinase (CDK) 4 inhibitor being studied in a global clinical development program in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The program includes KANDELA-302 (
NCT07492641
), a randomized Phase 3 clinical trial, initiated in Q2 2026 in first-line metastatic HR+/HER2- breast cancer. BGB-43395 is highly potent and selective CDK4 inhibitor and has the potential to reduce the dose-limiting hematologic toxicities that exist with the current CDK4/6 standard of care and may improve tolerability and enable deeper CDK4 inhibition.
About BG-C9074, a B7-H4-targeting ADC
BG-C9074, an investigational topoisomerase I inhibitor ADC that targets the B7-H4 protein, which is broadly expressed in breast and gynecologic cancers, is designed with an innovative drug linker to deliver a potent cancer-killing drug directly to the cancer cells. In a Phase 1 study of BG-C9074 (
NCT06233942
), patients with advanced solid tumors, irrespective of B7-H4 expression, received BG-C9074 every 3 weeks in escalating doses from 1 to 9 mg/kg. A subsequent safety expansion cohort received BG-C9074 in doses ranging from 4 to 8 mg/kg. Endpoints included safety, recommended dose for expansion, preliminary antitumor activity and pharmacokinetic measures.
About BGB-B2033, a GPC3x4-1BB bispecific antibody
BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in hepatocellular carcinoma (HCC),
3
and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.
4
The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity. BGB-B2033 is being investigated in a Phase 1 study (
NCT06427941
) in patients with GPC3-expressing advanced solid tumors with at least one prior line of therapy. Patients received BGB-B2033 every 3 weeks in eight escalating dose levels from 1 to 1000 mg, with various safety and anti-tumor activity endpoints. In December 2025, the FDA granted Fast Track Designation to BGB-B2033 for the treatment of HCC, followed by Orphan Drug Designation in March 2026.
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
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and
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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 its solid tumor pipeline; 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
Samant H, Amiri HS, Zibari GB. Addressing the worldwide hepatocellular carcinoma: epidemiology, prevention and management. J Gastrointest Oncol. 2021 Jul;12(Suppl 2):S361-S373. doi: 10.21037/jgo.2020.02.08. PMID: 34422400; PMCID: PMC8343080.
2
National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER) Program. Accessed April 2026.
3
Fanching Lin et al. Novel GPC3-targeting radiopharmaceutical therapy for hepatocellular carcinoma. J Clin Oncol 42, 525-525(2024).DOI:10.1200/JCO.2024.42.3_suppl.525
4
Kim DY et al. 4-1BB Delineates Distinct Activation Status of Exhausted Tumor-Infiltrating CD8+ T Cells in Hepatocellular Carcinoma. Hepatology, VOL. 71, NO. 3, 2020.
Contacts
Investor Contact
Liza Heapes
+1 857-302-5663
ir@beonemed.com
Media Contact
Kyle Blankenship
+1 667-351-5176
media@beonemed.com
Phase 1Clinical ResultASCOFast TrackPhase 3
21 May 2026
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.).
Phase 1ASCOPhase 3Clinical ResultImmunotherapy
06 May 2026
Total global revenues of $1.5 billion for the first quarter, an increase of 35% from the prior year
Foundational BRUKINSA (zanubrutinib) global revenues of $1.1 billion for the first quarter, an increase of 38% from the prior year
Diluted GAAP Earnings per American Depository Share (ADS) of $1.96 for the first quarter; non-GAAP diluted Earnings per ADS of $3.24 for the first quarter
SAN CARLOS, Calif.--(BUSINESS WIRE)--
$ONC
#BeOne
--
BeOne Medicines Ltd.
(NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the first quarter of 2026.
John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:
“These strong first-quarter results reinforce BeOne’s continued growth as a global oncology leader, driven by disciplined commercial execution, and underpinned by our established hematology leadership, and an impressive, rapidly emerging solid tumor pipeline. The sustained competitive advantages of our global superhighway for clinical development and manufacturing are now clear. BRUKINSA has firmly established itself as the foundational, best-in-class BTK inhibitor with unmatched long-term efficacy and safety data for the treatment of CLL and as the only BTKi with proven efficacy superiority over ibrutinib which has resulted in clear global revenue leadership. The fixed-duration combination of sonrotoclax, a foundational, next-generation BCL2 inhibitor, and BRUKINSA represents a potential new standard-of-care in first-line CLL, with BTK CDAC BGB-16673 emerging as a potential first-in-class therapy in the relapsed or refractory setting. With more than 20 abstracts across our hematology and solid tumor pipeline accepted for presentation at ASCO, BeOne has solidified its position as a leading oncology company.”
(Amounts in thousands of U.S. dollars and unaudited)
Three Months Ended
March 31,
2026
2025
% Change
Net product revenues
$
1,487,329
$
1,108,530
34
%
Other revenue
$
26,109
$
8,749
198
%
Total revenue
$
1,513,438
$
1,117,279
35
%
GAAP income from operations
$
249,902
$
11,102
2,151
%
Adjusted income from operations*
$
414,394
$
139,357
197
%
GAAP net income
$
227,357
$
1,270
17,802
%
Adjusted net income*
$
375,042
$
136,137
175
%
GAAP basic EPS per ADS
$
2.05
$
0.01
20,400
%
Adjusted basic EPS per ADS*
$
3.38
$
1.27
166
%
GAAP diluted EPS per ADS
$
1.96
$
0.01
19,500
%
Adjusted diluted EPS per ADS*
$
3.24
$
1.22
166
%
Free Cash Flow*
$
160,547
$
(12,325
)
1,403
%
* For an explanation of our use of non-GAAP financial measures, refer to the “Note Regarding Use of Non-GAAP Financial Measures” section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.
First Quarter 2026 Financial Results
Product Revenue
totaled $1.5 billion for the first quarter of 2026, representing growth of 34% compared to the prior-year period.
BRUKINSA: Global sales totaled $1.1 billion for the first quarter of 2026, representing growth of 38% compared to the prior-year period; U.S. sales of BRUKINSA totaled $761 million in the first quarter of 2026, representing growth of 35% compared to the prior-year period.
TEVIMBRA (tislelizumab): Global sales totaled $206 million in the first quarter of 2026, representing growth of 20% compared to the prior-year period.
Amgen in-licensed products: Global sales totaled $142 million in the first quarter of 2026, representing growth of 25% compared to the prior-year period.
Gross Margin
as a percentage of global product sales for the first quarter of 2026 was 89%, compared to 85% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA.
Operating Expenses
The following table summarizes operating expenses for the first quarter of 2026:
GAAP
Non-GAAP
(unaudited, in thousands, except percentages)
Q1 2026
Q1 2025
% Change
Q1 2026
Q1 2025
% Change
Research and development
$
541,224
$
481,887
12
%
$
465,904
$
421,195
11
%
Selling, general and administrative
$
555,097
$
459,288
21
%
$
471,993
$
395,511
19
%
Total operating expenses
$
1,096,321
$
941,175
16
%
$
937,897
$
816,706
15
%
Research and Development (R&D) Expenses
increased for the first quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing preclinical programs into the clinic and early clinical programs into late stage.
Selling, General and Administrative (SG&A) Expenses
increased for the first quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth. SG&A expenses as a percentage of product sales were 37% for the first quarter of 2026, compared to 41% in the prior-year period.
Net Income and Basic/Diluted Earnings Per Share
GAAP net income for the first quarter of 2026 was $227 million, an increase of $226 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage.
For the first quarter of 2026, basic and diluted earnings per share were $0.16 and $0.15 per share and $2.05 and $1.96 per American Depositary Share (ADS), compared to basic and diluted earnings per share of $0.00 per share and $0.01 per ADS in the prior-year period.
Free Cash Flow
for the first quarter of 2026 was $161 million, representing an increase of $173 million over the prior-year period.
For further details on BeOne’s First Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the first quarter of 2026 filed with the U.S. Securities and Exchange Commission.
Updated Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
Prior FY 2026 Guidance
Current FY 2026 Guidance
1
Total revenue
$6.2 - $6.4 billion
$6.3 - $6.5 billion
GAAP gross margin %
High-80% range
High-80% range
GAAP operating expenses
2
(combined R&D and SG&A)
$4.7 - $4.9 billion
$4.7 - $4.9 billion
GAAP operating income
2
$700 - $800 million
$750 - $850 million
Non-GAAP operating income
2,3
$1.4 - $1.5 billion
$1.45 - $1.55 billion
1
Assumes May 1, 2026 foreign exchange rates.
2
Does not assume any potential new, material business development activity or unusual/non-recurring items.
3
Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.
BeOne’s total revenue guidance for full year 2026 of $6.3 billion to $6.5 billion includes expectations for strong revenue growth driven by BRUKINSA’s leadership position in the U.S. and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage.
The Company is providing the following additional guidance on items impacting net income and earnings per ADS:
Other income (expense)
: Estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement.
Income tax outlook
: Earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship. See Form 10-Q for additional updates on income tax uncertainties.
Diluted ADS outstanding
: The Company expects diluted ADSs outstanding of approximately 118 million.
First Quarter 2026 Business Highlights
Core Marketed Products
BRUKINSA
(zanubrutinib)
Received Orphan Drug Designation in Japan for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL).
Submitted New Drug Application in Japan for R/R MZL and tablet formulation.
Sonrotoclax (BCL2 inhibitor)
Launched and commercially available in China for the treatment of adult patients with R/R mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Included in the European Society of Medical Oncology (ESMO) guidelines as a recommended third-line treatment for R/R MCL patients.
TEVIMBRA
(tislelizumab)
Received acceptance of a Supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) with Priority Review for the treatment of adult patients with first-line HER2-positive gastroesophageal adenocarcinoma (GEA) in combination with ZIIHERA (zanidatamab) and chemotherapy, based on results of the HERIZON-GEA-01 trial which demonstrated statistically significant and clinically meaningful improvement in overall survival versus trastuzumab plus chemotherapy.
Received acceptance of sBLA by the Center for Drug Evaluation (CDE) in China for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
ZIIHERA (zanidatamab)
Received acceptance of sBLA by the CDE in China for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
Select Clinical-Stage Programs
Hematology
BGB-16673 (BTK CDAC): Initiated Phase 2 cohorts in R/R MZL and Richter’s Transformation.
Breast and Gynecological Cancers
BGB-43395 (CDK4 inhibitor): Received acceptance of Phase 1 study data as a poster presentation at ASCO.
BG-C9074 (B7-H4 ADC): Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO.
Gastrointestinal Cancers
BGB-B2033 (GPC3x41BB bispecific antibody):
Received FDA Orphan Drug Designation for hepatocellular carcinoma (HCC).
Initiated potentially registrational study in patients with HCC.
Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO.
Lung Cancer
BG-C0979 (ADAM9-targeting ADC): Initiated first-in-human study.
Inflammation and Immunology
BG-A3004 (KLRG1 mAb): Initiated first-in-human study.
Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•
Interim analysis in the Phase 3 MANGROVE study data in combination with rituximab versus bendamustine plus rituximab for the treatment of adult patients with first-line MCL.
1H 2026
•
Japan regulatory action for the treatment of adult patients with first-line gastric cancer.
1H 2026
•
U.S. FDA regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA.
2H 2026
TEVIMBRA
•
China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA.
1H 2027
Hematology
•
Sonrotoclax (BCL2 inhibitor):
◦
FDA regulatory action on New Drug Application as monotherapy treatment of adult patients with R/R MCL.
1H 2026
◦
Phase 3 study initiation for the treatment of adult patients with R/R multiple myeloma t(11;14).
2H 2026
•
BGB-16673 (BTK CDAC):
◦
Phase 2 potential accelerated approval submission (if data support) for the treatment of adult patients with R/R CLL.
2H 2026
Breast/Gynecologic
•
BGB-43395 (CDK4 inhibitor):
Cancers
◦
Phase 3 study initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer.
1H 2026
Lung Cancer
•
BON-110 (PD-1xVEGF-AxCTLA-4 trispecific antibody):
◦
First-in-human study initiation.
1H 2026
Gastrointestinal
•
BGB-B2033 (GPC3x41BB bispecific antibody):
Cancers
◦
Pivotal Phase 3 study initiation.
2H 2026
Inflammation and
•
BGB-16673 (BTK CDAC):
Immunology
◦
Phase 2 study initiation for the treatment of adult patients with chronic spontaneous urticaria.
2H 2026
Corporate Updates
Entered into an exclusive option with Huahui Health to license worldwide rights to HH160 (BON-110), a novel trispecific antibody targeting PD-1, VEGF-A and CTLA-4.
BeOne’s Earnings Results Webcast
The Company’s earnings conference call for the first quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, May 6, 2026, and will be accessible through the Investors section of BeOne’s website at
. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.
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
and follow us on
LinkedIn
,
X
,
Facebook
and
Instagram
.
Forward-Looking Statements
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 continued growth as a global oncology leader; the fixed-duration combination of sonrotoclax and BRUKINSA as a potential new standard-of-care in first-line CLL; the emergence of BGB-16673 as a potential first-in-class therapy for R/R CLL; BeOne’s future revenue, gross margin percentage, operating expenses, operating income, other income or expense, income tax and diluted ADS outstanding; BeOne’s expectations regarding continued global expansion and investment to support growth; upcoming R&D milestones to be achieved by BeOne; the timing of clinical and regulatory developments and data readouts; and BeOne’s plans, commitments, aspirations and goals under the caption “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; BeOne’s 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 periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. 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. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.
Condensed Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)
Three Months Ended
March 31,
2026
2025
(Unaudited)
Revenues
Product revenue, net
$
1,487,329
$
1,108,530
Other revenue
26,109
8,749
Total revenues
1,513,438
1,117,279
Cost of sales - products
167,215
165,002
Gross profit
1,346,223
952,277
Operating expenses:
Research and development
541,224
481,887
Selling, general and administrative
555,097
459,288
Total operating expenses
1,096,321
941,175
Income from operations
249,902
11,102
Interest income
27,664
12,850
Interest expense
(32,887
)
(7,002
)
Other income, net
14,536
3,950
Income before income taxes
259,215
20,900
Income tax expense
31,858
19,630
Net income
$
227,357
$
1,270
Earnings per share
Basic
$
0.16
$
0.00
Diluted
$
0.15
$
0.00
Weighted-average shares outstanding—basic
1,442,451,870
1,390,052,966
Weighted-average shares outstanding—diluted
1,505,027,338
1,445,253,219
Earnings per American Depositary Share (“ADS”)
Basic
$
2.05
$
0.01
Diluted
$
1.96
$
0.01
Weighted-average ADSs outstanding—basic
110,957,836
106,927,151
Weighted-average ADSs outstanding—diluted
115,771,334
111,173,325
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
As of
March 31,
December 31,
2026
2025
(unaudited)
(audited)
Assets:
Cash, cash equivalents and restricted cash
$
4,853,425
$
4,609,647
Accounts receivable, net
938,019
865,080
Inventories
681,590
608,227
Property, plant and equipment, net
1,640,918
1,641,678
Total assets
$
8,553,619
$
8,188,573
Liabilities and equity:
Accounts payable
$
423,546
$
479,035
Accrued expenses and other payables
1,079,283
1,109,120
R&D cost share liability
35,700
64,345
Sale of future royalty liability
904,399
906,956
Debt
1,078,655
1,019,206
Total liabilities
3,793,177
3,827,379
Total equity
$
4,760,442
$
4,361,194
Select Condensed Consolidated Statements of Cash Flows (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
Three Months Ended
March 31,
2026
2025
(unaudited)
Cash, cash equivalents and restricted cash at beginning of period
$
4,609,647
$
2,638,747
Net cash provided by operating activities
201,336
44,082
Net cash used in investing activities
(45,510
)
(121,941
)
Net cash provided by (used in) financing activities
68,632
(33,777
)
Net effect of foreign exchange rate changes
19,320
3,480
Net increase (decrease) in cash, cash equivalents, and restricted cash
243,778
(108,156
)
Cash, cash equivalents and restricted cash at end of period
$
4,853,425
$
2,530,591
Note Regarding Use of Non-GAAP Financial Measures
BeOne provides certain non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Operating Loss, Adjusted Net Income, Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeOne’s operating performance. Adjustments to BeOne’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Non-GAAP adjustments are tax effected to the extent there is U.S. GAAP current tax expense. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. BeOne maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeOne believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeOne’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeOne’s management uses for planning and forecasting purposes and measuring BeOne’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by BeOne may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES
(Amounts in thousands of U.S. Dollars, except for per share and per ADS data)
(unaudited)
Three Months Ended
March 31,
2026
2025
Reconciliation of GAAP to adjusted cost of sales - products:
GAAP cost of sales - products
$
167,215
$
165,002
Less: Depreciation
4,326
2,613
Less: Amortization of intangibles
1,742
1,173
Adjusted cost of sales - products
$
161,147
$
161,216
Reconciliation of GAAP to adjusted research and development:
GAAP research and development
$
541,224
$
481,887
Less: Share-based compensation cost
53,856
41,767
Less: Depreciation
21,464
18,925
Adjusted research and development
$
465,904
$
421,195
Reconciliation of GAAP to adjusted selling, general and administrative:
GAAP selling, general and administrative
$
555,097
$
459,288
Less: Share-based compensation cost
69,492
53,684
Less: Depreciation
13,595
10,076
Less: Amortization of intangibles
17
17
Adjusted selling, general and administrative
$
471,993
$
395,511
Reconciliation of GAAP to adjusted operating expenses
GAAP operating expenses
$
1,096,321
$
941,175
Less: Share-based compensation cost
123,348
95,451
Less: Depreciation
35,059
29,001
Less: Amortization of intangibles
17
17
Adjusted operating expenses
$
937,897
$
816,706
Reconciliation of GAAP to adjusted income from operations:
GAAP income from operations
$
249,902
$
11,102
Plus: Share-based compensation cost
123,348
95,451
Plus: Depreciation
39,385
31,614
Plus: Amortization of intangibles
1,759
1,190
Adjusted income from operations
$
414,394
$
139,357
Reconciliation of GAAP to adjusted net income:
GAAP net income
$
227,357
$
1,270
Plus: Share-based compensation expenses
123,348
95,451
Plus: Depreciation
39,385
31,614
Plus: Amortization of intangibles
1,759
1,190
Plus: Impairment of equity investments
—
12,376
Plus: Discrete tax items
3,535
5,473
Plus: Income tax effect of non-GAAP adjustments
1
(20,342
)
(11,237
)
Adjusted net income
$
375,042
$
136,137
Reconciliation of GAAP to adjusted EPS - basic
GAAP earnings per share - basic
$
0.16
$
0.00
Plus: Share-based compensation expenses
0.09
0.07
Plus: Depreciation
0.03
0.02
Plus: Amortization of intangibles
0.00
0.00
Plus: Impairment of equity investments
0.00
0.01
Plus: Discrete tax items
0.00
0.00
Plus: Income tax effect of non-GAAP adjustments
1
(0.01
)
(0.01
)
Adjusted earnings per share - basic
$
0.26
$
0.10
Reconciliation of GAAP to adjusted EPS - diluted
GAAP earnings per share - diluted
$
0.15
$
0.00
Plus: Share-based compensation expenses
0.08
0.07
Plus: Depreciation
0.03
0.02
Plus: Amortization of intangibles
0.00
0.00
Plus: Impairment of equity investments
0.00
0.01
Plus: Discrete tax items
0.00
0.00
Plus: Income tax effect of non-GAAP adjustments
1
(0.01
)
(0.01
)
Adjusted earnings per share - diluted
$
0.25
$
0.09
Reconciliation of GAAP to adjusted earnings per ADS - basic
GAAP earnings per ADS - basic
$
2.05
$
0.01
Plus: Share-based compensation expenses
1.11
0.89
Plus: Depreciation
0.35
0.30
Plus: Amortization of intangibles
0.02
0.01
Plus: Impairment of equity investments
0.00
0.12
Plus: Discrete tax items
0.03
0.05
Plus: Income tax effect of non-GAAP adjustments
1
(0.18
)
(0.11
)
Adjusted earnings per ADS - basic
$
3.38
$
1.27
Reconciliation of GAAP to adjusted earnings per ADS - diluted
GAAP earnings per ADS - diluted
$
1.96
$
0.01
Plus: Share-based compensation expenses
1.07
0.86
Plus: Depreciation
0.34
0.28
Plus: Amortization of intangibles
0.02
0.01
Plus: Impairment of equity investments
0.00
0.11
Plus: Discrete tax items
0.03
0.05
Plus: Income tax effect of non-GAAP adjustments
1
(0.18
)
(0.10
)
Adjusted earnings per ADS - diluted
$
3.24
$
1.22
1. Tax effect of Non-GAAP adjustments is based on the statutory tax rate in the relevant tax jurisdiction. Please note that the Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects.
Contacts
Investor Contact
Liza Heapes
+1 857-302-5663
ir@beonemed.com
Media Contact
Kyle Blankenship
+1 667-351-5176
media@beonemed.com
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Phase 1Phase 2Phase 3Financial StatementOrphan Drug
100 Deals associated with BGB-B2033
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Endodermal Sinus Tumor | Phase 1 | United States | 23 Jul 2024 | |
| Endodermal Sinus Tumor | Phase 1 | China | 23 Jul 2024 | |
| Endodermal Sinus Tumor | Phase 1 | Japan | 23 Jul 2024 | |
| Endodermal Sinus Tumor | Phase 1 | Brazil | 23 Jul 2024 | |
| Endodermal Sinus Tumor | Phase 1 | France | 23 Jul 2024 | |
| Endodermal Sinus Tumor | Phase 1 | Italy | 23 Jul 2024 | |
| Endodermal Sinus Tumor | Phase 1 | New Zealand | 23 Jul 2024 | |
| Endodermal Sinus Tumor | Phase 1 | South Korea | 23 Jul 2024 | |
| Hepatocellular Carcinoma | Phase 1 | United States | 23 Jul 2024 | |
| Hepatocellular Carcinoma | Phase 1 | New Zealand | 23 Jul 2024 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1 | Solid tumor GPC3-expressing | 61 | jgcrgyiykp(vfepwblrpu) = qrfkwcmgyv jlikjmgwuz (xrlewnytck ) View more | Positive | 29 May 2026 |
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