Colon Pharmaceuticals (002422.SZ) subsidiary's core product, the new drug application for Bodutrazumab, was accepted

Zhitong Finance App News, Colon Pharmaceutical (002422.SZ) issued an announcement. The company recently learned that the company's holding subsidiary, Sichuan Colunbotai Biomedical Co., Ltd., an antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2), a new drug application (NDA) (previously known as A166) (hereinafter referred to as the “application”) has been accepted by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) for use in the past 2 positive unresectable or Treatment of adult patients with metastatic breast cancer.

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 HER2ADC developed by the 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.