Update on Amgen’s bemarituzumab Phase 3 FORTITUDE-101 Study

According to Amgen, Zai Lab’s partner and study sponsor, the final analysis of the Phase 3 FORTITUDE-101 trial evaluating bemarituzumab in combination with chemotherapy (mFOLFOX6) in first-line gastric cancer has been completed.At the pre-specified interim analysis, which was the primary analysis, the bemarituzumab plus chemotherapy regimen demonstrated a clinical and statistically significant improvement in overall survival (OS) compared to chemotherapy alone. However, at the final analysis, the magnitude of the previously observed survival benefit has attenuated. Amgen has indicated that the results from both the interim analysis and final analysis will be presented at an upcoming major medical meeting.Based on the updated results of the FORTITUDE-101 trial, Zai Lab intends to await the results of FORTITUDE-102, evaluating bemarituzumab in combination with nivolumab and chemotherapy in the same patient population, prior to regulatory filing. Data readout from FORTITUDE-102 is anticipated by the end of 2025 or the first half of 2026.Please refer to Amgen’s public statements made during the Wells Fargo Healthcare Conference on September 3, 2025. The link is provided below:https://event.webcasts.com/starthere.jsp?ei=1731776&tp_key=346b98b330&tp_special=8For more information, please contact:Investor Relations:Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 6943christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.comMedia:Shaun Maccoun/ Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 5011shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com