Core Insights - The company Kolonbo Tai Biotech-B (06990) has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Bodo Trastuzumab) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have previously received one or more anti-HER2 therapies [1][2] Group 1 - The approval is based on a multicenter, randomized, open-label, controlled Phase 3 study (KL166-III-06) that evaluated the efficacy and safety of Bodo Trastuzumab compared to T-DM1 in HER2-positive patients with unresectable or metastatic BC who had previously received trastuzumab and taxane treatments [1] - In the pre-specified interim analysis, Bodo Trastuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to T-DM1, as assessed by blinded independent central review (BICR) [1] - A trend towards improved overall survival (OS) with Bodo Trastuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [1] Group 2 - The company has initiated an open-label, multicenter Phase 2 clinical study of Bodo Trastuzumab for the treatment of HER2-positive unresectable or metastatic BC previously treated with an effective payload of topoisomerase inhibitor ADC [2] - Bodo Trastuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [2] - The drug specifically binds to HER2 on the surface of tumor cells, leading to internalization and release of the cytotoxic molecule Duo-5, which induces cell cycle arrest in the G2/M phase and triggers apoptosis in tumor cells [2]
科伦博泰生物-B：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