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China Approves Iza-bren for Advanced Esophageal Cancer Treatment

China's National Medical Products Administration has approved iza-bren for adults with recurrent or metastatic esophageal squamous cell carcinoma. This regulatory milestone marks the second indication for the EGFR × HER3 bispecific antibody-drug conjugate, offering a new pathway for patients whose disease progressed after standard platinum-based and PD-1/PD-L1 therapies.

China Approves Iza-bren for Advanced Esophageal Cancer Treatment

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.

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