Core Viewpoint - The announcement highlights that the bi-specific antibody-drug conjugate candidate SIM0610 developed by the company has received clinical trial approval from the National Medical Products Administration of China for trials targeting patients with locally advanced or metastatic solid tumors [1] Group 1: Drug Development - SIM0610 targets both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (cMET) as a bi-specific antibody-drug conjugate (BsADC) [1] - The drug induces apoptosis in tumor cells by releasing topoisomerase I inhibitors (TOP1i) through internalization [1] - Preclinical studies have shown significant anti-tumor activity of SIM0610 across various tumor models [1] Group 2: Mechanism of Action - EGFR and cMET are abnormally activated in several solid tumors, including non-small cell lung cancer [1] - Activation of cMET is a key mechanism for resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] - The dual-target approach of SIM0610 is expected to enhance anti-tumor activity and overcome drug resistance [1]
先声药业(02096.HK)：SIM0610获国家药监局签发药物临床试验批准通知书