BeOne Medicines Showcases Groundbreaking Oncology Pipeline at R&D Day

BRUKINSA, sonrotoclax, and BTK CDAC data, including combinations, are designed to comprehensively address unmet needs across CLL patient populations

Promising new data from pipeline assets in breast, lung, and GI cancer franchises, including CDK4 inhibitor, B7-H4 ADC, and novel PRMT5 inhibitor, will be featured

Pipeline is at an exciting inflection point with 20 near-term milestones in the next 18 months

SAN CARLOS, Calif.--(BUSINESS WIRE)--In a significant showcase for investors, BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will announce major advancements to its industry-leading oncology pipeline during today’s investor R&D Day. The event comes at a pivotal moment for the Company, which has more than 40 clinical and commercial stage assets in development, a signal of both scale and ambition.

“At BeOne, our mission is simple yet bold: to create the world’s first next-generation oncology company,” said John V. Oyler, Co-Founder, Chairman, and CEO. “What we will unveil demonstrates our progress towards this goal today, and the promise for tomorrow. From our innovative discovery engine to one of the broadest pipelines in oncology, we are well-positioned to bring transformative medicines to patients worldwide—and to do so with speed, quality, and purpose.”

BeOne’s integrated, end-to-end R&D model is engineered for efficiency without compromise. The Company’s differentiated approach—combining in-house discovery targeting unmet patient needs, parallel early-stage exploration at low incremental cost, and rapid proof-of-concept generation—enables swift progression from bench to clinic. Our in-house manufacturing around the world, including our flagship facility in Hopewell, NJ, means we have a sustainable business model, purpose built with competitive advantages. This rigorous model has fueled a pipeline of more than 40 clinical and commercial-stage assets, making it one of the most productive in the industry. To complement this research engine, BeOne has built a robust global clinical development platform, with more than 170 trials conducted across 40 countries and more than 25,000 patients enrolled to date.

In hematologic cancers, the Company’s program is driven by its wholly-owned assets including BRUKINSA^® (zanubrutinib), a second-generation covalent BTK inhibitor and the backbone of the hematology franchise, sonrotoclax, a potential best-in-class next-generation BCL2 inhibitor, and BGB-16673, a BTK CDAC. New clinical data from CaDAnCe-101 highlight the promise of BGB-16673, a potential first-in-class BTK degrader, for patients with relapsed or refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL). Meanwhile, early data show the combination of sonrotoclax and BRUKINSA has demonstrated compelling efficacy and the potential to offer a best-in-class fixed-duration treatment in CLL, setting the stage for a possible new standard of care.

In solid tumors, the Company is advancing multiple targeted modalities beyond its foundational PD-1 inhibitor TEVIMBRA^® (tislelizumab-jsgr), including CDK4 inhibitor BGB-43395, which has shown clear pharmacodynamic activity and is expected to enter registration-enabling studies for the treatment of breast cancer within the next six to 12 months.

Promising new data for the B7-H4 ADC (BG-C9074) point to a potential first-in-class therapeutic option for patients with B7-H4 expressing tumors, including those without selection criteria. Additionally, early data from the novel PRMT5 inhibitor suggest a favorable safety profile and promising efficacy, supporting its potential for differentiation in the competitive lung cancer field.

“Our R&D team is running at full speed,” said Lai Wang, Ph.D., Global Head of R&D. “With more than 1,200 scientists and more than 3,700 clinical development and medical affairs colleagues dedicated to pushing the boundaries of oncology, we have built the infrastructure, mindset, and capabilities to deliver sustained innovation. The volume of clinical milestones we anticipate over the next few years is extraordinary, and our agility in moving from idea to execution sets us apart.”

Speakers at today’s event include BeOne’s executive leadership team, senior R&D leaders, and distinguished key opinion leaders, offering a multi-faceted view of the Company’s scientific strategy and execution momentum. The live webcast begins at 8:30 a.m. U.S. Eastern Time and is available on the investor relations section of BeOne’s website, where an archived version will also be accessible.

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 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 the future success of BeOne’s pipeline assets; BeOne’s ability to bring transformative medicines to patients worldwide with both speed and quality; the productivity of BeOne’s pipeline; the ability of BeOne’s assets to provide a new standard of care; the timing for BGB-43395 to enter registration-enabling studies; 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; 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.

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