Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities

This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.

Start Date07 Feb 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06854003

/ Not yet recruitingPhase 2IIT

A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma

This study aims to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with Mantle Cell Lymphoma (MCL).
The names of the study drugs involved in this study are:
* bendamustine (a type of alkylating agent)
* rituximab (a type of monoclonal antibody)
* cytarabine (a type of antineoplastic)
* zanubrutinib (a type of kinase inhibitor)
* sonrotoclax (a type of BCL2 inhibitor)

Start Date01 Aug 2025

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06849713

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Start Date28 Jul 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

100 Clinical Results associated with Sonrotoclax

100 Translational Medicine associated with Sonrotoclax

100 Patents (Medical) associated with Sonrotoclax

Literatures (Medical) associated with Sonrotoclax

01 Aug 2025·CANCER LETTERS

Sonrotoclax (BGB-11417) synergistically amplifies the radiotherapy-elicited anti-tumor immune response

Article

Author: Liu, Xu ; Yu, Jinming ; Ma, Mengmeng ; Chen, Dawei ; Wu, Meng ; Tian, Chen ; Zhang, Zengfu ; Yuan, Jupeng

Escape from apoptosis is one of the main hallmarks of cancer. The imbalance of BCL-2 family members is a key factor leading to radiotherapy resistance. Targeting BCL-2 can overcome radiotherapy resistance by promoting apoptosis. Nevertheless, the function of BCL-2 in regulating the tumor immune microenvironment (TIME) is still not well understood. Herein, we discovered that the specific BCL-2 inhibitor sonrotoclax (BGB-11417) boosted the effectiveness of radiotherapy in an immune-mediated manner. Using flow cytometry, we found that sonrotoclax combined with radiotherapy polarized tumor-associated macrophages (TAMs) toward the M1-type and promoted the infiltration of Gzmb⁺ CD8⁺ T cells into the tumor. Mechanistically, we demonstrated that the combination of sonrotoclax and radiotherapy induced immunogenic ferroptosis of cancer cells by inhibiting GPX4 expression, released tumor-associated damage-associated molecular patterns (DAMPs) and subsequently activated the NF-κB pathway in TAMs. Moreover, the combination therapy also led to aberrant cytosolic DNA abundance and activated the cGAS-STING pathway in cancer cells, leading to the release of type I interferons and enhanced activation of CD8⁺ T cells. Meanwhile, the activation of cGAS-STING pathway also led to the upregulation of PD-L1 expression. Further combination of sonrotoclax and radiotherapy plus anti-PD-L1 exerted the most significant anti-tumor effects. Overall, our study indicated that sonrotoclax enhanced the anti-tumor immune response of radiotherapy through non-apoptotic roles of BCL-2, and shed light on the further clinical evaluation of the triple combination therapy of sonrotoclax, radiotherapy and immunotherapy.

01 Jun 2025·HEMATOLOGICAL ONCOLOGY

Diagnosis and Management of Waldenstrom's Macroglobulinemia.

Review

Author: Treon, Steven P ; Sarosiek, Shayna ; Castillo, Jorge J

Waldenström macroglobulinemia (WM) is an IgM secreting lymphoplasmacytic lymphoma. Mutations in MYD88 (95%-97%) and CXCR4 (30%-40%) are common in patients with WM. TP53 is also altered in up to 30% of WM patients, particularly those previously treated. Mutated MYD88 triggers the expression and activation of HCK that drives multiple pro-survival signaling cascades, including BTK. There are over 40 CXCR4 mutation types in WM. WM patients bearing nonsense CXCR4 variants can present with symptomatic hyperviscosity and show greater resistance to covalent BTK inhibitors (cBTK-i). The cBTK-i zanubrutinib shows greater response activity and/or improved progression-free survival in WM patients with wild-type MYD88, mutated CXCR4, or altered TP53. New or emerging options for patients progressing on c-BTKi include pirtobrutinib, BGB-16673, venetoclax, and sonrotoclax. Combinations of BTK inhibitors with chemoimmunotherapy and BCL2 antagonists have advanced. Algorithms for patients with treatment-naïve and previously treated WM based on genomics, disease characteristics, and co-morbidities are discussed.

28 Mar 2025·Future Oncology

Risk-stratified treatment of sonrotoclax with chemotherapy in newly diagnosed acute myeloid leukemia: a study protocol

Article

Author: Zhu, Hongming ; Liu, Ligen ; Huang, Xufei ; Jin, Zhen ; Li, Weiming ; Chen, Qiusheng ; Yang, Li ; Li, Junmin ; Zhang, Yunxiang ; Wu, Min ; Wang, Shaoyuan ; Chen, Zhichao ; Wang, Wenfang

Acute myeloid leukemia (AML) treatment relied on anthracyclines and cytarabine based intensive chemotherapy. However, clinical outcomes are unsatisfied for patients with intermediate/adverse cytogenetics based on European Leukemia Net (ELN) risk stratification 2022 (ELN 2022), and relapses also remain common even in patients with favorable-risk cytogenetics with measurable residual disease (MRD). There is an urgent unmet need for optimizing intensive chemotherapy regimens with novel agents, to enhance the MRD-negative rate, achieve durable remission, and improve the prognosis of AML. Preliminary results showed that adding a B-cell lymphoma-2 (BCL-2) inhibitor to intensive chemotherapy could improve treatment efficacy. Sonrotoclax is a potent, selective, next-generation BCL-2 inhibitor that effectively inhibits both the wide-type BCL-2 and several BCL-2 mutants. We hypothesize that the addition of sonrotoclax to intensive chemotherapy may enhance the treatment efficacy for AML without untoward toxicity. Here, we describe the rationale and design of a single-arm, multicenter, phase 2 study evaluating the efficacy and safety of sonrotoclax combined with chemotherapy as an induction therapy in newly diagnosed patients with AML who are fit for intensive chemotherapy, followed by stratified subsequent consolidation and maintenance treatment based on patients' ELN2022 at diagnosis and MRD results after induction.Clinical Trail Registration: NCT06497062.

News (Medical) associated with Sonrotoclax

12 Jun 2025

·www.businesswire.com

BeOne Medicines Showcases Breakthrough Data in CLL and MCL at EHA 2025

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will present new clinical data from three cornerstone hematology assets at the European Hematology Association (EHA) Congress. Four oral presentations highlight the promising clinical activity of BeOne’s next-generation BCL2 inhibitor sonrotoclax, BTK protein degrader BGB-16673, and the backbone of our hematology franchise, BTK inhibitor BRUKINSA (zanubrutinib), which has the broadest label globally of any approved BTK inhibitor. These data reinforce the company’s strategic vision to redefine the standard of care for B-cell malignancies. “The data presented at EHA 2025 underscore the strength of BeOne’s comprehensive hematology pipeline, built on the success of BRUKINSA, the only BTK inhibitor to demonstrate superior progression-free survival over ibrutinib in a Phase 3 trial,1” said Lai Wang, Ph.D. Global Head of R&D at BeOne. “With our potentially best-in-class BCL2 inhibitor, sonrotoclax, and first-in-class BTK degrader, BGB-16673, we are advancing innovative therapies aimed at addressing resistance mechanisms and improving outcomes for patients with B-cell malignancies.” The data presented at EHA 2025 support the ongoing advancement of sonrotoclax and BGB-16673 into Phase 3 studies and lay the groundwork for BeOne’s first regulatory submissions for these programs. The company’s integrated development approach—anchored in differentiated mechanisms and translational science—positions its programs to address key areas of unmet need in hematologic oncology. “While existing therapies have improved outcomes in CLL and related malignancies, many patients still relapse or develop resistance and continue to face limited options,” said Stephan Stilgenbauer, Professor of Medicine and Medical Director of the Comprehensive Cancer Center Ulm (CCCU), Head of the Early Clinical Trials Unit (ECTU), and Head of the Division of CLL Dept. of Internal Medicine III at Ulm University. “The updated data presented at EHA underscore the potential of novel approaches, including BTK degradation and BCL2-based combinations, to overcome known mechanisms of resistance and expand treatment options for patients.” Sonrotoclax + BRUKINSA Demonstrates Deep Responses in CLL and MCL BeOne’s data will highlight the emerging potential of its next-generation assets to address the unmet needs of patients with B-cell malignancies. Updated results from Phase 1 studies evaluating sonrotoclax in combination with BRUKINSA in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and with R/R mantle cell lymphoma (MCL) demonstrated consistent, deep responses and a manageable safety profile. Sonrotoclax is well-positioned to improve key aspects of the BCL2 inhibitor class and has demonstrated robust and durable antitumor activity and a tolerable safety profile across all dose levels. R/R CLL/SLL ( Oral Presentation S159 ): Overall response rate (ORR): 96%; complete response (CR): 52% across all dose levels Undetectable minimal residual disease (uMRD) was achieved in 82% of patients overall, with responses deepening over time No tumor lysis syndrome (TLS) or febrile neutropenia observed Overall response rate (ORR): 96%; complete response (CR): 52% across all dose levels Undetectable minimal residual disease (uMRD) was achieved in 82% of patients overall, with responses deepening over time No tumor lysis syndrome (TLS) or febrile neutropenia observed R/R MCL ( Oral Presentation S234 ): ORR: 79%; CR rate: 66%, with 84% of responders in ongoing response at data cutoff No TLS or atrial fibrillation/flutter reported; the most common grade ≥3 adverse event was neutropenia (19.6%) ORR: 79%; CR rate: 66%, with 84% of responders in ongoing response at data cutoff No TLS or atrial fibrillation/flutter reported; the most common grade ≥3 adverse event was neutropenia (19.6%) Robust Early Results in CLL and WM with Potentially First-in-Class BTK Degrader As the most clinically advanced BTK degrader, BGB-16673 continues to show potential in patients with various hematological malignancies. Updated data from the ongoing Phase 1 CaDAnCe-101 study of BGB-16673 in R/R CLL/SLL and R/R Waldenström macroglobulinemia (WM) showed substantial antitumor activity and a tolerable safety profile across heavily pretreated populations. R/R CLL/SLL ( Oral Presentation S158 ): ORR: 84.8% across all dose levels and 93.8% at the recommended phase 2 dose of 200mg Patients were heavily pretreated, with most previously treated with BTK and BCL2 inhibitors. The median number of prior therapies was four. Responses deepened over time Grade ≥3 adverse events included neutropenia (24%) and pneumonia (11%); no reported deaths were attributed to study drug ORR: 84.8% across all dose levels and 93.8% at the recommended phase 2 dose of 200mg Patients were heavily pretreated, with most previously treated with BTK and BCL2 inhibitors. The median number of prior therapies was four. Responses deepened over time Grade ≥3 adverse events included neutropenia (24%) and pneumonia (11%); no reported deaths were attributed to study drug R/R Waldenström Macroglobulinemia ( Oral Presentation S231 ): ORR: 84.4%; major response rate: 75.0%; very good partial response rate (VGPR): 31.3% Rapid onset of response (median: 1.0 month), with continued deepening over time Efficacy observed across genetic backgrounds and prior BTKi exposure Most common grade ≥3 TEAE was neutropenia/neutrophil count decreased (31%); no reported atrial fibrillation or febrile neutropenia. ORR: 84.4%; major response rate: 75.0%; very good partial response rate (VGPR): 31.3% Rapid onset of response (median: 1.0 month), with continued deepening over time Efficacy observed across genetic backgrounds and prior BTKi exposure Most common grade ≥3 TEAE was neutropenia/neutrophil count decreased (31%); no reported atrial fibrillation or febrile neutropenia. BRUKINSA Monotherapy Showed Sustained OS and PFS Benefit Data from Arm D of the SEQUOIA Phase 3 trial will also be presented at the meeting (Abstract PS1566), demonstrating that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. SEQUOIA Arm D investigated BRUKINSA plus venetoclax in 114 patients with treatment-naïve (TN) CLL / SLL with or without del(17p) and/or TP53 high-risk mutations. At a median follow-up of 31.2 months, the combination induced a high 24-month progression-free survival (PFS) rate of 92% (95% CI, 85-96%) and an impressive overall response rate (ORR) of 97%. The 24-month overall survival (OS) rate was 96% (95% CI, 90%-98%). Notably, these benefits were observed regardless of del(17p)/TP53 mutational status. The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. Arm C of the SEQUOIA study investigated BRUKINSA monotherapy in patients with TN CLL / SLL and del(17p) mutations, representing the largest prospective cohort of CLL/SLL patients with del(17p), will be presented at EHA (Abstract: PS1565). At a median follow-up of over 5.5 years (65.8 months), most patients remained progression-free. Notably, at 60 months, 72.2% of patients who received BRUKINSA remained progression-free (95% CI, 62.4, 79.8). When adjusted for the impact of the COVID-19 pandemic, 73.0% of patients in the cohort remained progression-free (95% CI, 63.3, 80.6) at 60 months. The 60-month OS rate was 85.1% (95% CI, 76.9, 90.6) and 87.0% (95% CI, 79.0, 92.1) when adjusted for COVID-19. At the time of data cut-off, the ORR was 97.3%, and 62.2% of patients were still receiving treatment with BRUKINSA. The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. BeOne will host an investor R&D Day on June 26 at 8:30 am ET covering our deep and broad global innovation pipeline and platforms, as well as the Company's vision, differentiated capabilities, and value creation drivers. The live webcast can be accessed from the investors section of BeOne’s website at https://ir.beonemedicines.com/, https://hkexir.beonemedicines.com/, or https://sseir.beonemedicines.com/. An archived replay will be available to investors for 90 days following the event. About Sonrotoclax (BGB-11417) Sonrotoclax is designed to block the B-cell lymphoma 2 (BCL2) protein, which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a potent and specific inhibitor of BCL2 with a short half-life and no accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and more than 1,900 patients have been enrolled to date across the global development program. The U.S. Food and Drug Administration (FDA) granted sonrotoclax Fast Track Designation for the treatment of adult patients with mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM). About BGB-16673 BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting protein degrader 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. BGB-16673 is the most advanced BTK protein degrader in the clinic, with an extensive global clinical development program. 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). 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. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate PFS superiority to a first-generation BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved for at least one indication in more than 75 markets, and more than 200,000 patients have been treated globally. Select Important Safety Information 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. 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 domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to 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. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. 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 the strength of BeOne’s hematology pipeline; BeOne’s ability to advance innovative therapies and improve outcomes for patients with B-cell malignancies; the ability of BeOne’s assets to address unmet needs of patients with B-cell malignancies and areas of hematologic oncology; the ability of sonrotoclax to improve the BCL2 inhibitor class and the asset’s future capabilities; the future potential of BGB-16673 in patients with hematological malignancies; the ability for BTK degradation and BCL2-based combinations to expand treatment options for patients; 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 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. 1 Brown, Jennifer R et al. “Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: final comparative analysis of ALPINE.” Blood vol. 144,26 (2024): 2706-2717. doi:10.1182/blood.2024024667

Clinical ResultPhase 3Phase 1Fast TrackDrug Approval

27 May 2025

·www.businesswire.com

BeOne Medicines Launches Following Redomiciliation to Switzerland, Marking a New Chapter in Global Oncology

SAN CARLOS, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company formerly known as BeiGene, Ltd., today announced its new name and redomiciliation to Switzerland are officially in effect, marking a significant milestone in the Company’s evolution. “BeOne represents more than a name change—it’s not only a reflection of who we are today as a leading global oncology company, but also our ambition to redefine what’s possible in oncology as we unite patients, families, scientists, physicians, governments, and other oncology public health stakeholders around the world in our shared mission against cancer,” said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. “While I know that our work is not done, I am extremely proud of the progress we have made with the explosive growth of BRUKINSA as the backbone of our hematology franchise, the expansion of our PD-1 inhibitor, TEVIMBRA, and our potentially transformative oncology pipeline of more than 50 investigational assets, one of the most prolific in the industry. After 15 years of relentless innovation and strategic investment to boost our internal global capabilities, we are just getting started, and I look forward to working together as BeOne.” The new name and redomiciliation to Switzerland from the Cayman Islands were approved by shareholders on April 28. The transition to the BeOne name across the Company’s worldwide operations on six continents will happen in phases. The redomiciliation to Switzerland strengthens BeOne’s presence and deepens its roots in a global biopharmaceutical hub, further enabling its growth strategy of bringing innovative medicines to patients around the world. Industry-Leading Innovation and Global Scale BeOne has built a differentiated and sustainable advantage through strategic investments to bolster its internal research, clinical development, and manufacturing capabilities. This unique model harnesses time and cost efficiencies to improve patient access, enables close oversight to enforce high standards across R&D and manufacturing, and safeguards our operational resilience for long-term growth. BRUKINSA has the broadest label in its treatment class and leads in new patient starts across all of its approved indications in the U.S. It also is the cornerstone of BeOne’s hematology franchise as a foundational treatment alongside late-stage BCL2 inhibitor sonrotoclax and potential first-in-class BTK protein degrader, BGB-16673, which was developed from the Company’s proprietary CDAC platform. BeOne also is focused on building future solid tumor franchises in breast, lung, and gastrointestinal cancers. By leveraging its platforms in multi-specific antibodies, protein degraders and antibody-drug conjugates, the Company is positioned to transform the future of oncology treatment. BeOne’s entrepreneurial research team, comprising more than 1,100 colleagues, advanced 13 new molecular entities into the clinic in 2024 alone, outpacing even the largest pharmaceutical companies. Further, its nearly 3,700-strong clinical development team has active or planned trials across more than 45 countries and regions, accelerating early-stage innovation through its “Fast to Proof-of-Concept” approach. To date, the Company has enrolled more than 25,000 patients in more than 170 trials, delivering speed and cost advantages that set it apart from industry peers. In addition, BeOne continues to expand its global manufacturing network with its $800 million flagship clinical R&D and manufacturing facility at the Princeton West Innovation Campus in Hopewell, N.J. This state-of-the-art site enables scalable production capacity to support the Company’s rapidly growing pipeline, operational resilience, and global ambitions. About BeOne BeOne Medicines, formerly known as BeiGene, is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to 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. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com 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 ability to deliver transformative treatments to patients worldwide; the potential and future success of BeOne’s oncology pipeline; BeOne’s presence in Switzerland and its ability to enable further growth; the sustainable advantage of BeOne’s strategic investments and its ability to improve patient access; the future long-term growth of the Company; BeOne’s ability to transform the future of oncology treatment; 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 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.

14 May 2025

·www.businesswire.com

BeiGene Showcases Strength of Hematology Portfolio at EHA 2025 with New Data Highlighting BRUKINSA’s Leadership and Next-Generation Innovation

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that will change its name to BeOne Medicines Ltd., today announced it will share data across a range of hematologic malignancies at the European Hematology Association (EHA) Congress in Milan, Italy, June 12–15. BeiGene has 31 abstracts accepted at EHA 2025, with four selected for oral presentations, featuring data from its best-in-class Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA® (zanubrutinib) and its investigational pipeline assets – a next-generation BCL2 inhibitor, sonrotoclax, and BTK protein degrader, BGB-16673. These data reflect BeiGene’s vision to redefine standards of care in hematology through next-generation science and patient-focused innovation. “With three cornerstone hematology assets – BRUKINSA, sonrotoclax and BGB-16673 – we are advancing a potentially best-in-class portfolio in B-cell malignancies,” said Lai Wang, Ph.D. Global Head of R&D. “At EHA 2025, we’ll share 31 accepted abstracts that highlight the progress of our hematology clinical development program and our commitment to targeted therapies that raise the standard of care. As BRUKINSA continues to expand its impact and our next-generation assets advance, we hope to transform the future of treatment for patients facing B-cell malignancies.” BeiGene’s next-generation pipeline assets, including BGB-16673 and sonrotoclax, continue to demonstrate promising clinical activity and generally well-tolerated safety profiles across multiple B-cell malignancies. Together, these programs have enrolled more than 2,500 patients globally (1,900+ patients for sonrotoclax and 600+ patients for BGB-16673) and are positioned to potentially play a significant role in treatment strategies for chronic lymphocytic leukemia (CLL), Waldenström’s macroglobulinemia (WM) and mantle cell lymphoma (MCL). Additionally, presentations further reinforce BRUKINSA’s durable efficacy and consistent safety profile, as well as its position as a foundational therapeutic option in frontline CLL. Key highlights include: Two oral presentations featuring updated results from the ongoing Phase 1 CaDAnCe-101 study of BGB-16673 in patients with relapsed or refractory (R/R) CLL/SLL and patients with R/R WM, showing continued and promising early efficacy and a tolerable safety profile. Two oral presentations showcasing updated Phase 1 results of sonrotoclax in combination with BRUKINSA in R/R CLL/SLL and R/R MCL, which demonstrate deep and durable responses. This combination is now under evaluation in the ongoing registrational Phase 3 fixed-duration CELESTIAL-TNCLL study ( NCT06073821 ) in patients with treatment-naïve CLL/SLL, which completed enrollment earlier this year, and CELESTIAL-RRMCL study ( NCT06742996 ) in patients with relapsed / refractory MCL, which is currently enrolling. Results from Arm C and D of the SEQUOIA study, which evaluated BRUKINSA in patients with TN CLL/SLL and del(17p) (Arm C) and BRUKINSA plus venetoclax in patients with TN CLL/SLL with del(17p) and/or TP53 mutation or without either mutation (Arm D). Robust analyses across clinical trials and real-world evidence that deepen understanding of treatment patterns, safety, and outcomes in CLL/SLL, MCL and diffuse large B-cell lymphoma (DLBCL). BeiGene Presentations and Publications at EHA2025 Abstract Title Presentation Details (CEST) Lead Author BGB-16673 (BTK CDAC) Updated efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory CLL/SLL: results from the ongoing phase 1 CaDAnCe-101 study Oral Presentation: S158 Session Title: Chronic lymphocytic leukemia and related disorders - Clinical Session Date/Time: Sunday, June 15, 11:00 - 12:15 L. Scarfò Updated efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed/refractory Waldenström macroglobulinemia: ongoing phase 1 CaDAnCe-101 study results Oral Presentation: S231 Session Title: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical Session Date/Time: Saturday, June 14, 17:00 – 18:15 A.M. Frustaci Sonrotoclax (BCL2 Inhibitor) Updated results from the phase 1 study of sonrotoclax (BGB-11417), a novel BCL2 inhibitor, in combination with zanubrutinib for relapsed/refractory CLL/SLL show deep and durable responses Oral Presentation: S159 Session Title: Chronic lymphocytic leukemia and related disorders - Clinical Session Date/Time: Sunday, June 15, 11:00 - 12:15 C.Y. Cheah Combination treatment with novel BCL2 inhibitor sonrotoclax (BGB-11417) and zanubrutinib induces high rate of complete remission for patients with relapsed/refractory mantle cell lymphoma Oral Presentation: S234 Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical Session Date/Time: Saturday, June 14, 17:00 – 18:15 C.S. Tam Sonrotoclax monotherapy for treatment of patients with relapsed/refractory CLL: data from an ongoing phase 1/1b study (BGB-11417-101) Poster #: PF580 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 S.S. Opat Updated safety and efficacy results of a phase 1 study of the novel BCL2 inhibitor sonrotoclax (BGB-11417) for relapsed/refractory Waldenström's macroglobulinemia Poster #: PF887 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 C.Y. Cheah Primary analysis results of novel BCL2 inhibitor sonrotoclax (BGB-11417) monotherapy in patients with relapsed/refractory b-cell malignancies Poster #: PF574 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 C. Li Updated safety and antileukemic activity data for sonrotoclax (BGB-11417), a potent and selective BCL2 inhibitor, in patients with relapsed/refractory acute myeloid leukemia Poster #: PF491 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 P. Montesinos Updated safety and antileukemic activity data of sonrotoclax (BGB-11417), a potent and selective BCL2 inhibitor, in treatment-naive patients with acute myeloid leukemia unfit for intensive chemotherapy Poster #: PF477 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 J. Shortt Updated interim results of sonrotoclax plus dexamethasone in patients with t(11;14)-positive relapsed/refractory multiple myeloma: an all-oral treatment Poster #: PF721 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 B. Dhakal BGB-11417-302, a phase 3, randomized, double-blind study of sonrotoclax (BGB-11417) plus zanubrutinib versus placebo plus zanubrutinib in patients with relapsed or refractory mantle cell lymphoma Publication Only M. Hughes BRUKINSA SEQUOIA 5-year follow-up in arm C: frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma Poster #: PS1565 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 C.S. Tam Combination of zanubrutinib plus venetoclax for treatment-naive CLL/SLL: results in SEQUOIA arm D Poster #: PS1566 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 M. Shadman Final analysis of a phase 1 study of zanubrutinib plus lenalidomide in patients with relapsed/refractory diffuse large b-cell lymphoma Poster #: PS1918 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 Z. Song Additional Abstracts Integrative Evidence Generation and Health Economics Related to Zanubrutinib Final independent review data supports sustained benefit of zanubrutinib over ibrutinib in patients with R/R CLL/SLL in ALPINE Publication Only J. Brown Preference Survey and Patient Experience Study Preferences for treatment in first-line chronic lymphocytic leukemia: A multi-criteria decision analysis in Italy Publication Only P. Sportoletti A qualitative study to explore the patient experience of continuous covalent Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia: study methodology Publication Only L. Scarfò Real-World Evidence Real-world burden of disease, treatment patterns and outcomes in patients with mantle cell lymphoma Poster #: PF899 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 A. Alencar Real-world comparative effectiveness of first-line Bruton tyrosine kinase inhibitors in patients with chronic lymphocytic leukemia Poster #: PS1578 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 R. Jacobs Real-world treatment utilization patterns, discontinuation and healthcare resource utilization of first-line Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia: age-related disparity Poster #: PF585 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 K. Yang Risk of hypertension in patients newly diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and treated with covalent Bruton tyrosine kinase inhibitors: a real-world study Poster #: PF588 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 A. Ali Real-world Bruton tyrosine kinase inhibitor use and clinical outcomes among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma Publication Only J. Hou Real-world zanubrutinib treatment patterns in chronic lymphocytic leukemia/small lymphocytic lymphoma among US community oncology patients with prior acalabrutinib therapy Publication Only J. Hou Real-world zanubrutinib treatment patterns in mantle cell lymphoma among US community oncology patients with prior Bruton tyrosine kinase inhibitor therapy Poster #: PF914 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 R. Choksi Evaluating uptake of targeted agents by race/ethnicity in patients receiving first-line treatment for chronic lymphocytic leukemia Publication Only A.S. Kittai Serious infections in patients with CLL/SLL treated with combination venetoclax and obinutuzumab compared with those treated with zanubrutinib: a real-world study Poster #: PS1571 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 N. Lamanna Matching-Adjusted Indirect Comparison Comparative efficacy of zanubrutinib versus fixed-duration acalabrutinib plus venetoclax for first-line treatment of chronic lymphocytic leukemia: a matching-adjusted indirect comparison Poster #: PS1581 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 T. Munir Efficacy of continuous zanubrutinib vs fixed-duration venetoclax in combination with obinutuzumab in treatment-naive chronic lymphocytic leukemia: a matching-adjusted indirect comparison Publication only T. Munir Adverse events of interest with zanubrutinib vs fixed-duration combination of venetoclax plus obinutuzumab in treatment-naive chronic lymphocytic leukemia Publication only N. Lamanna Network Meta-Analysis A network meta-analysis of efficacy of zanubrutinib versus fixed-duration acalabrutinib plus venetoclax in treatment-naïve chronic lymphocytic leukemia Publication Only M. Shadman Ociperlimab (BGB-A1217) Advantig-101: a phase 1b/2 study of ociperlimab plus tislelizumab or rituximab in relapsed/refractory diffuse large b-cell lymphoma Poster #: PS1995 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 Q. Cai About Sonrotoclax (BGB-11417) Sonrotoclax is designed to block the B-cell lymphoma 2 (BCL2) protein, which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a potent and specific inhibitor of BCL2 with a short half-life and no accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and more than 1,900 patients have been enrolled to date across the global development program. The U.S. Food and Drug Administration (FDA) granted sonrotoclax Fast Track Designation for the treatment of adult patients with mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM). About BGB‑16673 BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting protein degrader from BeiGene’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. BGB-16673 is the most advanced BTK protein degrader in the clinic, with an extensive global clinical development program. 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). 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. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets, and more than 200,000 patients have been treated globally. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström’s macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Adverse Reactions The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Drug Interactions CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Specific Populations Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily. Please see full U.S. Prescribing Information including U.S. Patient Information. This information is intended for a global audience. Product indications vary by region. About BeiGene BeiGene, which will change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeiGene, please visit www.beigene.com. 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 the strength of BeiGene’s hematology portfolio; BeiGene’s commitment to transform treatment for B-cell malignancies; BeiGene’s commitment to targeted therapies that raise the standard of care; the future impact of BRUKINSA; the advancement of BeiGene’s next-generation assets including clinical activities and safety profiles; the role BGB-16673 and sonrotoclax will play in treatment strategies for CLL, WM and MCL; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene'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; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’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 BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene'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 BeiGene undertakes no duty to update such information unless required by law. To access BeiGene media resources, please visit our News & Media site.

Phase 1Phase 3Clinical ResultDrug ApprovalFast Track

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Indication	Highest Phase	Country/Location	Organization	Date
Mantle-Cell Lymphoma	NDA/BLA	China	BeiGene (Suzhou) Co. Ltd.	12 May 2025
Chronic Lymphocytic Leukemia	NDA/BLA	China	BeiGene (Suzhou) Co. Ltd.	29 Apr 2025
Small Lymphocytic Lymphoma	NDA/BLA	China	BeiGene (Suzhou) Co. Ltd.	29 Apr 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	United States	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	China	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Argentina	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Australia	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Austria	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Belgium	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Brazil	BeOne Medicines Ltd.	11 Jun 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04883957 (BGB-11417-102, EHA2025)	Phase 1	-	64	Sonrotoclax 80 mg	bomswifwvi(zxfdwnqiry) = not reached up to 640 mg once daily mfrwnkiaab (aycnbjqnks ) View more	Positive	14 May 2025
				Sonrotoclax 160 mg
NCT04277637 (BGB-11417-101, EHA2025)	Phase 1	Recurrent Chronic Lymphoid Leukemia del(17p) \| unmutated IGHV genes	18	Sonrotoclax 80 mg	jxjbrglszz(btuejlxvra) = qkitiiioaa vzfoffbqph (wtqsmzhtwl ) View more	Positive	14 May 2025
				Sonrotoclax 160 mg	jxjbrglszz(btuejlxvra) = oirooyifmg vzfoffbqph (wtqsmzhtwl ) View more
NCT04771130 (BGB-11417-103, EHA2025)	Phase 1/2	Acute Myeloid Leukemia BCL2	79	Sonrotoclax + Azacitidine	cqsssnveuv(tbzqphcefm) = kxuvxmfzib dfihgqqpcx (fvgmjsrfxr ) View more	-	14 May 2025
NCT04973605 (BGB-11417-105, EHA2025)	Phase 1/2	Multiple Myeloma t(11;14)-positive	50	Sonrotoclax 320 mg + Dexamethasone 40 mg	vnpbahdlpz(pijjutjuyy) = occurred in 5 pts (35.7%) in the 320-mg cohort and 17 pts (47.2%) in the 640-mg cohort ifvqghzvga (zdblyicyjk ) View more	Positive	14 May 2025
				Sonrotoclax 640 mg + Dexamethasone 40 mg
NCT04277637 (BGB-11417-101, EHA2025)	Phase 3	Mantle cell lymphoma refractory	49	Sonrotoclax	djhmdozatz(uapatmzhwk) = 30.6% hjjiwgnswp (beupveanrh ) View more	Positive	14 May 2025
NCT04277637 (BGB-11417-101, EHA2025)	Phase 1	Chronic Lymphocytic Leukemia del(17p) \| unmutated IGHV	47	Sonrotoclax + Zanubrutinib	pjzlzjrqnm(gzktjrymvs) = olycjaqxsa hxmrfeodgb (hdxwcziphj ) View more	Positive	14 May 2025
NCT04277637 (BGB-11417-101, EHA2025)	Phase 1	Waldenstrom's macroglobulinaemia refractory BCL2	23	Sonrotoclax 80 mg	qiexlcprxc(vgriokllvi) = COVID-19 (n=8; 34.8%) qorxdkjzzb (wzfoccuubc ) View more	-	14 May 2025
				Sonrotoclax 160 mg
NCT04771130 (BGB-11417-103, EHA2025)	Phase 1/2	Refractory acute myeloid leukemia	68	Sonrotoclax + Azacitidine	fbeiynfvse(dboovtvovt) = ywructahbx kcdiilavwx (lannijbtiw ) View more	Positive	14 May 2025
NCT04277637 (BGB-11417-101, ASH2024) Manual	Phase 1	Chronic Lymphocytic Leukemia	112	zanubrutinib + Sonrotoclax 160 mg	bnhivuoqay(mtjbauqrus) = neutropenia (41%), contusion (38%), COVID-19 (30%), and diarrhea (29%; 78% had grade 1 events). Neutropenia was the most common grade ≥3 TEAE (n=29, 26%). pirxtsfeuv (rtjigzxpgm )	Positive	09 Dec 2024
				zanubrutinib + Sonrotoclax 320 mg
NCT04277637 (BGB-11417-101, EHA 12024 \| EHA 22024) Manual	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	45	SONROTOCLAX + ZANUBRUTINIB	vggoytpqtx(kudvagfkun) = Any-grade treatment-emergent AEs (TEAEs) that occurred in ≥20% of patients wereCOVID-19 (n=12; 27%), contusion (n=12 [27%]), neutropenia (n=12 [27%]), diarrhea (n=11 [24%]), nausea(n=11 [24%]) and fatigue (n=11 [24%]) kadvqicfaw (ediociftym )	Positive	14 May 2024

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