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
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.
