The approval stems from the phase 3 PANKU-Esophagus01 trial, which involved 497 patients across 80 centers. Data presented at the 2026 American Society of Clinical Oncology meeting showed the drug outperformed chemotherapy in both overall survival and progression-free survival. Patients treated with iza-bren achieved a median overall survival of 9.8 months, compared to 7.2 months in the chemotherapy cohort, with a manageable safety profile and only 2.0% treatment discontinuation due to adverse events.

Dr. Yi Zhu, CEO of parent company Biokin, noted that the result validates the potential of their bispecific platform to address difficult-to-treat cancers. Esophageal squamous cell carcinoma remains a significant health challenge, accounting for roughly 90% of esophageal cancer cases in China. With limited second-line options available, the introduction of iza-bren provides a targeted alternative for those who have exhausted initial immunochemotherapy. SystImmune continues to evaluate the drug across other malignancies, including breast and non-small cell lung cancers.