Iza-bren granted BTD in China for the treatment of mTNBC

CAR-T Digest - August 2020

22 September 2026: Iza-bren granted BTD in China for the treatment of mTNBC

Biokin announced that Iza-bren, its first-in-class EGFR×HER3 bispecific ADC, has received China NMPA Breakthrough Therapy Designation for use in combination with a PD-1 antibody as first-line treatment for patients with PD-L1-positive locally recurrent, unresectable or metastatic triple-negative breast cancer
The BTD marks the eighth China Breakthrough Therapy designation for Iza-bren across indications, underscoring the breadth of its clinical development; the newly designated first-line TNBC setting further expands its potential use into an earlier line of treatment
The designation addresses an unmet need in first-line PD-L1-positive TNBC, an aggressive breast cancer subtype where treatment outcomes remain limited and patients can develop resistance to immune checkpoint-based therapy, supporting investigation of a targeted ADC plus PD-1 combination
Iza-bren is an EGFR×HER3 bispecific ADC designed to simultaneously engage EGFR and HER3 on tumor cells, enabling targeted delivery of its cytotoxic payload following receptor-mediated internalization
Strategically, the BTD further strengthens Iza-bren’s regulatory positioning in China and triggers a milestone under SystImmune’s 2023 global collaboration with Bristol Myers Squibb; following the US$800 million upfront and US$250 million first near-term milestone, a separate phase 3 IZABRIGHT-Lung02 milestone has triggered a second US$250 million contingent payment, expected to be paid to SystImmune