Core Viewpoint - The announcement highlights that the company has received approval from the National Medical Products Administration of China for clinical trials of its self-developed anti-tumor candidate drug SIM0609, targeting advanced solid tumors [1] Group 1: Drug Development - SIM0609 is a novel antibody-drug conjugate (ADC) targeting Cadherin 17 (CDH17), which is highly expressed in various cancers, including gastric cancer, colorectal cancer, and pancreatic cancer [1] - The drug is composed of a humanized monoclonal antibody linked to a new type of topoisomerase I (TOP-I) inhibitor developed by the company through a proprietary water-soluble cleavable linker [1] Group 2: Clinical Trial Focus - The clinical trials will focus on advanced solid tumors, particularly gastrointestinal tumors, indicating the drug's potential as a therapeutic target in late-stage cancer treatment [1]
先声药业:SIM0609(CDH17抗体偶联药物)获国家药品监督管理局签发药物临床试验批准通知书