江苏亚虹医药科技股份有限公司自愿披露关于APL-2401完成I期临床试验首例受试者入组公告

Core Viewpoint - Jiangsu Yahon Pharmaceutical Technology Co., Ltd. has completed the first subject enrollment in the Phase I clinical trial of APL-2401, a selective FGFR2/3 dual-target small molecule inhibitor for advanced solid tumors [2][4]. Group 1: Drug Information - APL-2401 is a high-selectivity small molecule inhibitor targeting FGFR2/3, potentially providing a new treatment option for patients with advanced solid tumors such as urothelial carcinoma, cholangiocarcinoma, endometrial cancer, gastric cancer, breast cancer, ovarian cancer, non-small cell lung cancer, and other specific solid tumors [2][3]. - The drug was optimized through the TAIDD platform, demonstrating superior dual kinase inhibition activity and reduced side effects compared to existing FGFR2 or FGFR3 selective inhibitors [3]. Group 2: Clinical Trial and Regulatory Approval - APL-2401 is a globally developed Class 1 innovative drug, with its clinical trial design and submission materials meeting international standards. It was approved by the National Medical Products Administration (NMPA) in just 22 working days, becoming one of the first projects to benefit from the new regulatory policy [4]. - The first administration of the drug occurred only 15 working days after approval, marking it as one of the projects that significantly benefited from the expedited clinical development process [4].