Biokin：BL-B01D1 has been formally accepted for review.
On June 11, the CDE official website showed that a new indication New Drug Application (NDA) for Biokin Pharmaceutical’s BL-B01D1 for Injection has been accepted. Based on clinical trial progress, the Insight database speculates that the indication is for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) that has failed prior taxane-based therapy. This marks the third indication for which BL-B01D1 has been submitted for marketing approval.
BL-B01D1 (iza-bren) is an EGFR×HER3 bispecific ADC developed by Biokin Pharmaceutical. It blocks EGFR- and HER3-mediated signaling to tumor cells through a dual mechanism of action, thereby inhibiting their proliferation and survival signals. Additionally, through antibody-mediated internalization, BL-B01D1 releases its therapeutic payload, inducing genotoxic stress and ultimately leading to tumor cell death.
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