先声药业:SIM0610(EGFR/cMET双特异性抗体偶联药物)获国家药监局签发药物临床试验批准通知书

Core Viewpoint - The company announced that its self-developed bispecific antibody-drug conjugate (BsADC) candidate SIM0610 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: Product Development - SIM0610 targets both epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (cMET), releasing topoisomerase I inhibitors (TOP1i) to induce apoptosis in tumor cells [1] - The activation of EGFR and cMET is abnormally high in various solid tumors, including non-small cell lung cancer, with cMET activation being a significant mechanism for resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] - Preclinical studies have shown that SIM0610 exhibits significant anti-tumor activity across various tumor models [1] Group 2: Company Overview - The company is an innovation and research-driven pharmaceutical firm, operating a "National Key Laboratory for Neuroscience and Oncology Drug Development" [1] - The company focuses on neuroscience, anti-tumor, autoimmune, and anti-infection fields, while proactively positioning itself in areas with significant clinical needs [1] - The company emphasizes its mission of "born for patients" through self-innovation and collaborative innovation, establishing strategic partnerships with various innovative enterprises and research institutions [1]