DualityBio announced that the BLA for the investigational ADC trastuzumab pamirtecan (“T-Pam”, also known as DB-1303 or BNT323), has been accepted for review by the China National Medical Products Administration (NMPA). With the BLA filing, DualityBio is seeking approval for trastuzumab pamirtecan as second-line treatment for patients with unresectable or metastatic HER2-positive breast cancer. The application is based on positive interim results from the pivotal Phase III clinical trial (Study DB-1303-O-3001).