DUALITYBIO's core product DB-1303/BNT323 listing application has been accepted
DualityBio-B (09606.HK) announced that the company's core products DB-1303/BNT323 have received positive results from the pivotal Phase III clinical study, and based on the feedback from the communication with the Center for Drug Evaluation of the National Medical Products Administration regarding the new drug application, the submitted new drug application for the biological product has been accepted by the National Medical Products Administration.
The Phase III clinical trial aims to evaluate the efficacy and safety of DB-1303 compared to T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane treatment
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