Columbotai Bio-B (06990): The application for the new drug, the core product Bodutrastuzumab, was accepted by the State Drug Administration

Zhitong Finance App News, Colunbotai Bio-B (06990) announced that the new drug application (NDA) (NDA) (NDA) (previously known as A166), an antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2), has been accepted by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) for the treatment of adult patients with HER2-positive unresectable or metastatic breast cancer who have received at least one anti-HER2 treatment in the past.

The application is based on a multicenter, randomized, open, controlled, phase III KL166-III-06 clinical study to evaluate the efficacy and safety results of bodutrazumab monotherapy compared with emmetrotuzumab (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously been treated with trastuzumab and taxus. In the pre-set mid-term analysis, compared with T-DM1, bodutrastuzumab monotherapy showed significant statistically significant and clinically significant improvements in progression-free survival (PFS) assessed by the main study endpoint blind independent center assessment (BICR).

Bodutrastuzumab is an innovative HER2 ADC developed by our company. It couples a novel MMAF derivative (highly cytotoxic microtubulin inhibitor Duo-5) with a HER2 monoclonal antibody through a stabilized enzyme. The drug antibody ratio (DAR) is 2. Bodutrazumab specifically binds to HER2 on the surface of tumor cells and is endocytosed by tumor cells to release the toxin molecule Duo-5 within the cell. Duo-5 induces tumor cell cycle to block the G2/M phase, causing tumor cell apoptosis. Bodutrastuzumab can also inhibit the HER2-mediated signaling pathway after targeting HER2; it has antibody-dependent cell-mediated cytotoxic (ADCC) activity.