SKB BIO-B(06990): the new drug application for the core product Bortezomib monoclonal antibody has been accepted by the National Medical Products Administration.

SKB BIO-B (06990) announced that the new drug application (NDA) for the antibody-drug conjugate (ADC) Bodetuzumab monokine antibody (formerly known as A166), targeting human epidermal growth factor receptor 2 (HER2), has been accepted by the National Medical Products Administration Drug Evaluation Center (CDE) in China for the treatment of HER2-positive unresectable or metastatic breast cancer in adults who have previously received at least one anti-HER2 therapy. This application is based on a multicenter, randomized, open-label, controlled, Phase III clinical study, KL166-III-06, evaluating the efficacy and safety of Bodetuzumab monokine antibody monotherapy compared to Trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic breast cancer patients who have previously received trastuzumab and taxane therapy. In a pre-specified interim analysis, Bodetuzumab monokine antibody monotherapy demonstrated a significant and clinically meaningful improvement in progression-free survival (PFS) assessed by blinded independent central review (BICR) compared to T-DM1. Bodetuzumab monokine antibody is an innovative HER2 ADC developed by the company, which conjugates a novel MMAF derivative (highly cytotoxic microtubule inhibitor Duo-5) with HER2 monoclonal antibody through a stable enzyme cleavable linker, with a drug antibody ratio (DAR) of 2. Bodetuzumab monokine antibody specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 intracellularly. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. Bodetuzumab monokine antibody can also inhibit HER2-mediated signaling pathways after binding to HER2 and exhibits antibody-dependent cell-mediated cytotoxicity (ADCC) activity.