DUALITYBIO-B (09606) has announced that its Biologics License Application (BLA) for DB-1303/BNT323 has been accepted by the National Medical Products Administration (NMPA). This submission is based on positive outcomes from the pivotal Phase III clinical trial, designated DB-1303-O-3001, and feedback received during pre-submission communications with the Center for Drug Evaluation of the NMPA.

The DB-1303-O-3001 trial is a randomized, controlled, open-label, multicenter Phase III study designed to evaluate the efficacy and safety of DB-1303 compared to T-DM1 in adults with HER2-positive unresectable or metastatic breast cancer who have previously been treated with trastuzumab and a taxane.

Following an assessment by the Independent Data Monitoring Committee (IDMC), the Phase III trial has met its primary endpoint of progression-free survival (PFS). A prespecified interim analysis demonstrated that DB-1303 showed a statistically significant and clinically meaningful improvement in the primary endpoint compared to the control group, with a favorable safety and tolerability profile.