Biokin Pharma announces approval of Iza-bren in China for the treatment of recurrent/metastatic ESCC

CAR-T Digest - August 2020

Weekly Digest - July 2026

17 July 2026: Biokin Pharma announces approval of Iza-bren in China for the treatment of recurrent/metastatic ESCC

Biokin Pharma announced that China’s NMPA has approved Iza-bren for the treatment of adults with recurrent or metastatic esophageal squamous cell carcinoma following progression on platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy, marking the second approved indication in China for the first-in-class EGFR×HER3 bispecific antibody-drug conjugate
The approval is supported by the pivotal phase 3 PANKU-Esophagus01 trial, where Iza-bren significantly improved median overall survival (9.8 vs. 7.2 months; HR=0.64) and median progression-free survival (4.2 vs. 2.0 months; HR=0.50) versus chemotherapy, while demonstrating a manageable safety profile with low treatment discontinuation and a low incidence of interstitial lung disease
The approval addresses a significant unmet need in recurrent or metastatic ESCC, where patients progressing after platinum-based chemotherapy and immunotherapy have historically faced limited second-line treatment options and poor clinical outcomes, with median overall survival generally remaining below one year
Iza-bren is an EGFR×HER3 bispecific ADC that combines dual receptor blockade with targeted intracellular delivery of a proprietary topoisomerase I inhibitor payload, enabling simultaneous inhibition of EGFR/HER3 signaling and potent cytotoxic activity across EGFR/HER3-expressing epithelial tumors
Strategically, the second approval further strengthens SystImmune’s leadership in bispecific ADC development, expands the clinical footprint of Iza-bren beyond nasopharyngeal carcinoma, and reinforces the company’s strategy of establishing the EGFR×HER3 ADC across multiple solid tumors through an extensive global development program in partnership with Bristol Myers Squibb