Core Viewpoint - The approval of the antibody-drug conjugate (ADC) Bodo-Tuzumab (A166) by the National Medical Products Administration (NMPA) for the treatment of HER2-positive breast cancer represents a significant advancement in targeted therapy for patients with previously treated, unresectable, or metastatic conditions [1][2]. Group 1: Product Approval - The NMPA has approved Bodo-Tuzumab for adult patients with HER2-positive breast cancer who have received one or more prior anti-HER2 therapies [1]. - The approval is based on the results of a multicenter, randomized, open-label, controlled Phase III study (KL166-III-06) comparing Bodo-Tuzumab to Trastuzumab Emtansine (T-DM1) [2]. Group 2: Clinical Study Results - The study demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) for Bodo-Tuzumab compared to T-DM1, as assessed by blinded independent central review (BICR) [2]. - A trend towards improved overall survival (OS) with Bodo-Tuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [2]. Group 3: Product Characteristics - Bodo-Tuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [3]. - The drug specifically targets HER2 on tumor cells, leading to internalization and release of the cytotoxic agent Duo-5, which induces cell cycle arrest and apoptosis in tumor cells [3]. - Bodo-Tuzumab also exhibits antibody-dependent cell-mediated cytotoxicity (ADCC) activity and inhibits HER2-mediated signaling pathways [3].
科伦博泰生物-B(06990)：核心产品博度曲妥珠单抗治疗2L+ HER2+乳腺癌获国家药品监督管理局批准上市