BeOne (ONC) Secured a Pharmaceutical-Tariff Exemption After More than $1B of U.S. Manufacturing Investment. Are the Pricing Concessions Worth It?

BeOne Medicines presented data at ESMO 2026 on three investigational cancer treatments. GPC3 x 4-1BB bispecific showed 36% ORR in liver cancer, PRMT5 inhibitor demonstrated 25.3% ORR in lung cancer, and CEA-targeting ADC achieved 56% ORR in high-CEA lung cancer. The company plans global trials for these treatments.

BeOne Medicines reported new data from the HERIZON-GEA-01 Phase 3 trial, showing 36-month overall survival of nearly 40% with TEVIMBRA plus ZIIHERA and chemotherapy in first-line HER2+ gastroesophageal cancer. The TEVIMBRA-containing arm had a median OS of 27 months, four months longer than ZIIHERA plus chemotherapy. The results were presented at the ESMO Congress 2026.

BeOne Medicines reported results from its HERIZON-GEA-01 Phase 3 trial, showing median overall survival of 27.0 months for TEVIMBRA plus ZIIHERA and chemotherapy, with a hazard ratio of 0.65. ZIIHERA plus chemotherapy alone showed 22.9 months. The trial met a primary endpoint with a p-value of 0.0088. The study involved 914 patients across 30 countries, with no new safety signals identified.

BeOne Medicines presented data from its solid tumor pipeline at ESMO 2026, including updates on GPC3x4-1BB bispecific antibody, CEA targeting ADC, CDK4 inhibitor, and PRMT5 inhibitor. The company also shared evidence for TEVIMBRA in lung and gastrointestinal cancers, including a combination with ZIIHERA in HER2+ gastroesophageal adenocarcinoma. BeOne aims to advance these therapies toward pivotal development.

BeOne Medicines (ONC) announced FDA approval for TEVIMBRA in combination with ZIIHERA and chemotherapy for HER2-positive gastroesophageal adenocarcinoma. The approval is based on Phase 3 trial data showing a median survival of 26.4 months. The company reported Q2 2026 revenue of $1.7 billion, up 30% YoY, and raised full-year revenue guidance to $6.6B-$6.8B. However, a Phase 3 study for zanubrutinib-sonrotoclax combination did not meet its primary endpoint.

President Trump's administration signed drug-pricing agreements with nine mid-sized pharmaceutical companies, including Astellas Pharma, Teva, and UCB, to lower U.S. drug prices under the MFN proposal. Companies agreed to reduce prices and invest $19.6B in U.S. manufacturing, with some contributing APIs to a government reserve. The deals cover 89% of the branded drug market, expanding beyond initial Big Pharma focus.