• First regulatory approval for iza-bren (BL-B01D1), a first-in-class EGFR×HER3 bispecific antibody-drug conjugate (ADC)
• Represents an important new treatment option for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy

SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, announced that its parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), has received regulatory approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for iza-bren (BL-B01D1) for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This approval marks the first regulatory approval for iza-bren and represents a significant milestone in the development of SystImmune's proprietary bispecific antibody-drug conjugate platform.

The approval is based on results from the pivotal Phase III BL-B01D1-303 study (NCT06118333). In this study, Iza-bren demonstrated a BICR-assessed confirmed ORR of 54.6% vs. 27.0% for chemotherapy (Odds Ratio 3.3; 95% confidence interval 1.9-5.8; p<0.0001). Median duration of response (DoR) was 8.5 months for iza-bren versus 4.8 months for physician's choice of chemotherapy (Hazard ratio 0.43; 95% CI 0.22 to 0.83). Furthermore, median progression-free survival (PFS) was 8.38 months for iza-bren compared to 4.34 months for chemotherapy (hazard ratio of 0.44; 95% confidence interval 0.32-0.62). At the time of this analysis, the overall survival (OS) data were immature.

"This approval represents a significant milestone for patients with recurrent or metastatic nasopharyngeal carcinoma and for the development of iza-bren," said Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. "Patients who have progressed following platinum-based chemotherapy and immunotherapy face a poor prognosis with limited treatment options. The approval of iza-bren provides a new therapeutic option that has demonstrated clinically meaningful improvements in tumor response and progression-free survival compared to chemotherapy."

"Today marks a historic milestone for Biokin and SystImmune as we celebrate the first regulatory approval of iza-bren anywhere in the world," said Dr. Yi Zhu, Chairman and Chief Executive Officer of Biokin. "In fact, this is the first bispecific ADC approval of any kind globally. This approval validates our innovative EGFR×HER3 bispecific ADC design and the potential of our proprietary brengitecan-based ADC platform. Most importantly, it brings an important new treatment option to patients with recurrent or metastatic nasopharyngeal carcinoma who urgently need better therapies. We thank the patients, investigators, and healthcare professionals who made this achievement possible and look forward to advancing iza-bren for patients worldwide across multiple tumor types."