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

TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status

Regimen poised to become standard of care in this difficult-to-treat disease.

SAN CARLOS, Calif., August 25, 2026--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive (HER2+) gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA). The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which were published in The New England Journal of Medicine earlier this year.

GEA, which includes adenocarcinomas of the stomach, gastroesophageal junction and esophagus, remains an area of substantial unmet need in the United States, with more than 31,000 new stomach cancer cases diagnosed each year.1 Approximately 20% of patients with GEA have HER2+ disease, a subtype that has historically been difficult to treat.2,3,4

Despite recent advances, long-term outcomes for patients with advanced or metastatic HER2+ GEA remain challenging and the need for more effective first-line options is urgent. In the U.S., fewer than 40% of patients survive beyond two years. These outcomes highlight the need for additional treatment options that may help extend survival for patients facing this disease.

Jaffer A. Ajani, M.D., Professor of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, said:

"For patients with advanced HER2-positive gastroesophageal adenocarcinoma, first-line treatment represents a critical opportunity to make the greatest possible impact and change the course of disease at the start of care, making it especially important to provide the most effective treatment options and combinations upfront to give patients the best possible chance for improved outcomes. The median overall survival of more than two years observed with this regimen demonstrates meaningful progress in a setting where outcomes have historically been challenging to improve. With benefit observed across PD-L1 subgroups, this approval gives physicians greater freedom to select treatment regardless of PD-L1 status."