The authorization from the Center for Drug Evaluation of the China National Medical Products Administration marks a breakthrough for Sichuan Biokin Pharmaceutical, the parent company of Redmond-based SystImmune. The approval is anchored in the Phase III BL-B01D1-303 study, which evaluated iza-bren against physician-choice chemotherapy. Patients receiving the new therapy achieved an objective response rate of 54.6%, compared to 27.0% in the control group. Furthermore, the drug extended median progression-free survival to 8.38 months, nearly doubling the 4.34-month outcome observed with traditional chemotherapy.

Iza-bren functions by simultaneously targeting EGFR and HER3 receptors, which are frequently overexpressed in epithelial cancers. Once the antibody binds to these receptors and is internalized, it releases a novel Topo1i payload to induce cancer cell death. For patients with nasopharyngeal carcinoma—a cancer endemic to southern China and Southeast Asia—the treatment addresses a critical gap in care. With five-year survival rates for recurrent cases historically falling below 10%, medical professionals view the dual-action mechanism as a vital addition to the oncology toolkit. SystImmune is currently coordinating with partners to advance the drug’s development for additional tumor types globally.