Sonrotoclax

Company outlines foundational hematology leadership, multiple 2026 data catalysts, a unique global clinical development superhighway, and continued financial excellence SAN CARLOS, Calif.--(BUSINESS WIRE)-- $ONC #BeOne -- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will outline the pillars of its growing global oncology leadership during its presentation today at the 44 th Annual J.P. Morgan Healthcare Conference in San Francisco. John V. Oyler, Co-Founder, Chairman, and CEO at BeOne, will highlight the Company’s transformative leadership in treating B-cell malignancies. The presentation will feature BRUKINSA ® , the global leader among Bruton’s tyrosine kinase (BTK) inhibitors, as well as foundational hematology assets: sonrotoclax, a next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor that received its first global regulatory approvals on December 30, and BGB-16673, a potentially first-in-class and best-in-class BTK chimeric degradation activation compound (CDAC). In addition, Mr. Oyler will share further information on BeOne’s global development superhighway, which encompasses global, wholly internal, and competitively advantaged clinical capabilities that can greatly reduce the cost and time to develop a new medicine, thereby increasing the speed of access to innovation for patients around the world. “BeOne is emerging as the world’s leading oncology company with established leadership in the treatment of B-cell malignancies, an industry-leading pipeline and a unique set of internal capabilities to address tremendous unmet patient need around the world,” Mr. Oyler said. “BRUKINSA has entrenched itself as the best-in-class, foundational BTK inhibitor and global revenue leader with an unparallelled long-term efficacy and safety pro all approved indications. The investigational combination of BRUKINSA and BCL2 inhibitor sonrotoclax has the potential to change the fixed-duration treatment landscape for CLL with best-in-class rates and kinetics of minimal residual disease. BGB-16673 is the most advanced BTK degrader in the clinic and continues to emerge as a potential first-in-class and best-in-class treatment. Combining one of the industry’s most innovative research teams with our vertically integrated clinical development capabilities puts us in a strong position for our next phase of growth with a solid financial pro a growing global footprint.” Key themes from BeOne’s presentation (7:30 a.m. PT, Tuesday, Jan. 13, 2026) at the J.P. Morgan Healthcare Conference include: BeOne is the only company with potentially best-in-class, foundational medicines in three key MOAs in CLL BeOne is the leading company in the treatment of chronic lymphocytic leukemia (CLL) with three approved or clinical-stage foundational medicines addressing all patient subtypes. BRUKINSA is now the global revenue leader in the BTKi class and the only BTKi to demonstrate superior progression-free survival (PFS) and cardiac safety pro ibrutinib in a Phase 3 head-to-head trial. At the American Society of Hematology (ASH) Annual Meeting in December, the Company presented landmark six-year results from the global, Phase 3 SEQUOIA trial of BRUKINSA versus bendustamine plus rituximab (BR) in treatment-naïve CLL or small lymphocytic lymphoma with an estimated 74% PFS compared with 32% PFS for BR. The overall survival (OS) at 72 months was 84% for BRUKINSA and 80% with BR. After adjusting for COVID-19, the OS rates were 88% and 82%, respectively. BeOne is rapidly advancing the investigational combination of BRUKINSA and sonrotoclax as a potential best-in-class fixed-duration regimen for the treatment of first-line CLL with clinical results showing potential best-in-class rates of undetectable minimal residual disease (uMRD) at the earliest time as exploratory endpoints. The Company anticipates uMRD results from the Phase 3 CELESTIAL trial of zanubrutinib plus sonrotoclax (ZS) versus venetoclax plus obinutuzumab (VO) in 2026. In addition, the Company continues to advance BGB-16673 as a potentially first-in-class and best-in-class targeted degrader of BTK with Phase 1 trial results in heavily pretreated CLL patients at a median follow-up of 18 months demonstrating an overall response rate of 86% and 12-month progression-free survival of 79%. The Company anticipates potentially pivotal Phase 2 trial results for BGB-16673 in R/R CLL in 2026. BeOne’s peerless global development superhighway combined with an industry-leading oncology R&D team drives faster development, accelerated regulatory registrations, and broader global patient access BeOne is leveraging one of the largest oncology research teams in the industry alongside nearly 6,000 clinical development and manufacturing colleagues supporting the Company’s wholly internal, strategically advantaged global development superhighway to rapidly bring our medicines to cancer patients around the world. The Company’s dedicated team of research scientists holds deep expertise in designing innovative small-molecule inhibitors, biologics, targeted protein degraders, multispecific antibodies and antibody drug conjugates. In the past 18 months, the Company has advanced 15 New Molecular Entities (NME) into the clinic across a broad range of modalities and expects to deliver an additional eight to 10 NMEs per year into the clinic starting in 2026. BeOne plans to share updates for the following programs, each of which has achieved clinical proof of concept and presents a significant market opportunity: CDK4 inhibitor, B7-H4 ADC, PRMT5 inhibitor, GPC3x41BB bispecific antibody, and CEA ADC. A strong financial pro investment for BeOne’s future growth BeOne’s strong financial position enables the Company to achieve greater global scale while maintaining profitability in 2026 and beyond. The Company generated more than $350 million in free cash flow in the third quarter of 2025 with more than $4 billion in cash on hand. BeOne will continue to invest in driving innovation across its hematology and solid tumor pipelines to maximize long-term value for patients and shareholders while pursuing value-creating business development, including opportunities to leverage the Company’s global development superhighway. Live webcast of BeOne’s presentation can be accessed from the investors section of the Company’s website at . Archived replays will be available on the Company’s website. About BeOne Medicines BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more 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. The Company has a growing global team of nearly 12,000 colleagues 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 anticipated presentation at the 44 th Annual J.P. Morgan Healthcare Conference; the potential of sonrotoclax to be a best-in-class BCL2 inhibitor and BGB-16673 to be a first-in-class BTK CDAC; BeOne’s internal capabilities to drive innovation to address unmet patient need around the world; the potential of the combination of BRUKINSA and sonrotoclax to treat CLL; BeOne’s positioning for growth; anticipated timing of results from BeOne’s clinical trials of ZS versus VO and BGB-16673; BeOne’s expectations with respect to advancing NMEs into the clinic; BeOne’s ability to achieve greater global scale while maintaining profitability; BeOne’s plans to continue to invest in commercial assets and geographies that drive profitable growth; 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 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. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Contacts Investor Contact Liza Heapes +1 857-302-5663 ir@beonemed.com Media Contact Kyle Blankenship +1 667-351-5176 media@beonemed.com