BeOne Medicines AG

BeOne Presents Compelling Data in Hard-to-Treat Liver and Lung Cancers at ESMO 2026

BeOne presented broad positive solid tumor data at ESMO 2026, headlined by its first-in-class GPC3 x 4-1BB bispecific BGB-B2033 hitting a 36.0% confirmed ORR at the recommended Phase 3 dose in heavily pretreated hepatocellular carcinoma, versus roughly 5% for TKIs in the late-line setting. First-in-human data also impressed in NSCLC: the brain-penetrant PRMT5 inhibitor BGB-58067 posted a 25.3% confirmed ORR in MTAP-deficient disease with 7.7-month median PFS and 30.8% intracranial ORR in brain metastases, while the CEA-targeting ADC BG-C477 achieved a 56.0% ORR in CEA-high NSCLC. BeOne plans registrational HCC trials for BGB-B2033 by end of 2026, late-stage development for both NSCLC assets in 2027, and is enrolling the global Phase 3 KANDELA-302 study of its CDK4 inhibitor in first-line HR+/HER2- breast cancer. Both NSCLC assets hold FDA Fast Track Designations, and the data strengthen BeOne's expansion beyond its established TEVIMBRA (tislelizumab) franchise.

•9d ago

BeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal Cancer

BeOne Medicines reported new long-term survival data from the Phase 3 HERIZON-GEA-01 trial, with the TEVIMBRA plus ZIIHERA and chemotherapy regimen delivering median overall survival of 27.0 months in first-line HER2+ gastroesophageal cancer. After 35.3 months of follow-up, nearly 40% of patients on the TEVIMBRA-containing arm were alive at three years (39.8% 36-month OS), with an OS hazard ratio of 0.65 versus trastuzumab plus chemotherapy; the benefit held regardless of PD-L1 status. Adding TEVIMBRA to ZIIHERA plus chemotherapy added four months of median OS (27.0 vs 22.9 months) but did not reach statistical significance (P=0.0502) in what the company described as an underpowered analysis; no new safety signals were identified. Presented as a late-breaking abstract at ESMO 2026, the data reinforce the regimen the FDA approved in August as a potential new standard of care in first-line HER2+ GEA.

•9d ago

BeOne Medicines Highlights Rapidly Accelerating Solid Tumor Franchise at ESMO 2026

BeOne Medicines will present data across its solid tumor portfolio at the ESMO 2026 Congress in Madrid on October 23-27, including a late-breaking rapid oral on TEVIMBRA plus ZIIHERA in HER2+ gastroesophageal adenocarcinoma (second interim analysis of Phase 3 HERIZON-GEA-01). Priority pipeline data include updated Phase 1 results for the GPC3x4-1BB bispecific in advanced HCC and first-in-human reads for a CEA-targeting ADC in NSCLC and a brain-penetrant PRMT5 inhibitor in MTAP-deleted tumors. A trial-in-progress abstract covers KANDELA-302, a global Phase 3 study of the CDK4 inhibitor BGB-43395 in first-line HR+/HER2- metastatic breast cancer. No new results are disclosed in this announcement; the data become available at the congress.

•13d ago

BeOne Medicines Announces Voluntary Agreement with U.S. Government to Expand Access to Innovative Cancer Medicines

BeOne Medicines entered a voluntary agreement with the U.S. government to participate in the GENEROUS Model, securing an exemption from Section 232 pharmaceutical tariffs. The tariff exemption supports the company's $1 billion total U.S. manufacturing investment, which includes a recently announced $300 million expansion at its New Jersey facility. BeOne also committed to pricing future FDA-approved products in line with other key developed markets to broaden patient access.

•2mo ago

BeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal Cancer

BeOne Medicines reported positive topline results from the second interim analysis of the Phase 3 HERIZON-GEA-01 trial, demonstrating a statistically significant overall survival benefit for ZIIHERA plus chemotherapy versus the standard of care. The data reinforced the efficacy of the TEVIMBRA plus ZIIHERA and chemotherapy regimen, which recently received FDA approval based on prior interim results showing median overall survival exceeding two years. These findings are strategically significant for BeOne given its exclusive rights to ZIIHERA in Asia, Australia, and New Zealand, regions with a high burden of gastroesophageal cancer.

•2mo ago

BeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEA

The FDA approved BeOne Medicines' TEVIMBRA in combination with ZIIHERA and chemotherapy for first-line treatment of HER2-positive gastric or gastroesophageal junction adenocarcinoma. Approval is backed by Phase 3 HERIZON-GEA-01 data showing median overall survival of 26.4 months, a significant improvement over the control arm's 19.2 months, with benefits observed across all PD-L1 subgroups. This regimen is the first immunotherapy-based option to deliver more than two years of median survival in this setting, marking a key milestone for TEVIMBRA as BeOne's foundational solid tumor asset.

•2mo ago

BeOne Medicines and Revolution Medicines Announce Clinical Development and Regional Commercialization Collaboration

BeOne Medicines entered a strategic collaboration with Revolution Medicines to evaluate combinations of its own oncology assets with Revolution's four clinical-stage RAS(ON) inhibitors. Under a regional rights agreement, BeOne gained exclusive development and commercialization rights to these four Revolution assets in select Asian markets, while Revolution retains rights in other regions including Japan and South Korea. BeOne will fund and conduct a global registrational Phase 3 study for one of the RAS(ON) inhibitors as part of the arrangement.

•2mo ago

BeOne Medicines Announces Second Quarter 2026 Financial Results and Business Updates

BeOne Medicines reported Q2 2026 revenue of $1.7 billion, up 30% year-over-year, with Non-GAAP diluted EPS of $3.84. The company raised full-year 2026 revenue guidance to $6.6 billion to $6.8 billion, citing momentum in its foundational hematology franchise led by BRUKINSA, which generated $1.2 billion in Q2 sales. Strategic highlights included FDA accelerated approval for BEQALZI in relapsed or refractory mantle cell lymphoma and positive Phase 3 results for BRUKINSA.

•2mo ago

BeOne Medicines Expands U.S. Manufacturing with Total Investment of More Than $1 Billion to Advance Innovative Cancer Medicines

BeOne Medicines announced a $300 million expansion of its flagship manufacturing facility in Hopewell, New Jersey, adding small molecule drug product capabilities to its existing biologics production. This investment brings the total capital commitment to the Princeton West Innovation Campus to over $1 billion and is expected to create 120 new full-time jobs, with operations slated for 2029. CFO Aaron Rosenberg cited supportive federal tax policies and state manufacturing programs as key enablers of the company's long-term growth and U.S. footprint expansion.

•3mo ago