Biokin Pharma secures first China approval for Iza-bren in Nasopharyngeal carcinoma

Weekly Digest - June 2026

22 June 2026: SystImmune secures first China approval for Iza-bren in Nasopharyngeal carcinoma

Biokin Pharma has received NMPA approval for Iza-bren for the treatment of recurrent or metastatic nasopharyngeal carcinoma following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy, marking the world’s first approval of an EGFR×HER3 bispecific antibody-drug conjugate and a major milestone for patients with limited treatment options
The approval was supported by results from the pivotal phase 3 BL-B01D1-303 trial, where Iza-bren achieved a confirmed objective response rate of 54.6% compared with 27.0% for chemotherapy, while also demonstrating a median duration of response of 8.5 months versus 4.8 months and a median progression-free survival of 8.38 months versus 4.34 months, significantly outperforming physician’s choice chemotherapy
The approval provides a new treatment option for recurrent or metastatic NPC patients who have progressed after standard chemotherapy and immunotherapy, a population with poor prognosis and a five-year overall survival rate typically below 10%, highlighting the substantial unmet need in this setting
Iza-bren is a first-in-class EGFR×HER3 bispecific ADC that simultaneously blocks EGFR and HER3 signaling pathways while delivering a proprietary brengitecan-based topoisomerase I inhibitor payload, combining dual-target inhibition with targeted cytotoxic activity against tumor cells
Strategically, the approval represents the first regulatory approval of any bispecific ADC globally, validating SystImmune’s proprietary ADC platform and establishing a strong foundation for broader development of Iza-bren across multiple tumor types, while strengthening the company’s position in the increasingly competitive next-generation ADC landscape