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映恩生物-B:DB-1303/BNT323用于HER2阳性不可切除或转移性乳腺癌患者的III期临床试验达到主要研究终点
Zhi Tong Cai Jing· 2025-09-05 09:19
Core Viewpoint - The announcement indicates that the clinical trial for DB-1303/BNT323 has met its primary endpoint of progression-free survival (PFS) compared to the control group in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane treatments [1] Group 1: Clinical Trial Details - The trial is a randomized, controlled, open-label, multi-center Phase III clinical study conducted in China [1] - The objective of the trial is to evaluate the efficacy and safety of DB-1303 compared to T-DM1 in the specified patient population [1] Group 2: Regulatory Plans - Following the interim analysis results, the company plans to communicate with the Center for Drug Evaluation of the National Medical Products Administration in China regarding the submission of a Biologics License Application (BLA) for DB-1303/BNT323 [1]