The New Drug Application (NDA) for DB-1303/BNT323 for unresectable or metastatic HER2-positive adult breast cancer has been accepted by the NMPA

CAR-T Digest - August 2020

Weekly Digest - April 2026

09 April 2026: The New Drug Application (NDA) for DB-1303/BNT323 for unresectable or metastatic HER2-positive adult breast cancer has been accepted by the NMPA

DualityBio’s HER2 ADC DB-1303 (BNT323 / Trastuzumab Pamirtecan) has been accepted by China’s NMPA for BLA review in unresectable/metastatic HER2+ breast cancer
The application is supported by the Phase 3 DB-1303-O-3001 trial, a randomized study conducted in China
DB-1303 showed statistically significant and clinically meaningful improvement in PFS vs T-DM1, meeting its primary endpoint with favorable safety
The trial enrolled pretreated patients (prior trastuzumab + taxane), addressing a high unmet need in HER2+ metastatic breast cancer
DB-1303 is a next-generation HER2-targeting ADC built on DualityBio’s DITAC platform, designed to enhance anti-tumor activity, it is developed globally across multiple cancer types, and has received BTD and FTD from regulatory agencies