CHENGDU, China I January 07, 2025 I The board (the “Board”) of directors (“Directors”) of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) is pleased to announce that the new drug application (NDA) (the “Application”) for human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) trastuzumab botidotin (formerly A166) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with HER2 positive unresectable or metastatic breast cancer (BC) who have received at least one prior anti-HER2 therapy.
The approval is based on a multi-center, randomized, open-label, controlled, phase III KL166-III-06 study that evaluates the efficacy and safety results of trastuzumab botidotin monotherapy versus T-DM1 in patients with HER2 positive unresectable or metastatic BC who have received prior trastuzumab and Taxane-containing regimens. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent central review (BICR) compared with T-DM1.
Trastuzumab botidotin is an innovative HER2 ADC developed by the Company, which conjugates a novel, MMAF derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a drug-to-antibody-ratio (DAR) of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.
SOURCE: Sichuan Kelun-Biotech Biopharmaceutical Co
Post Views: 29
CHENGDU, China I January 07, 2025 I The board (the “Board”) of directors (“Directors”) of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) is pleased to announce that the new drug application (NDA) (the “Application”) for human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) trastuzumab botidotin (formerly A166) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with HER2 positive unresectable or metastatic breast cancer (BC) who have received at least one prior anti-HER2 therapy.
The approval is based on a multi-center, randomized, open-label, controlled, phase III KL166-III-06 study that evaluates the efficacy and safety results of trastuzumab botidotin monotherapy versus T-DM1 in patients with HER2 positive unresectable or metastatic BC who have received prior trastuzumab and Taxane-containing regimens. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent central review (BICR) compared with T-DM1.
Trastuzumab botidotin is an innovative HER2 ADC developed by the Company, which conjugates a novel, MMAF derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a drug-to-antibody-ratio (DAR) of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.
SOURCE: Sichuan Kelun-Biotech Biopharmaceutical Co
Post Views: 29
