亚虹医药(688176.SH)：APL-2401临床试验申请获得国家药品监督管理局批准

Core Viewpoint - The company, Yahui Pharmaceutical (688176.SH), has received approval from the National Medical Products Administration (NMPA) for its clinical trial application of APL-2401 (ASN-8639 tablets) in patients with advanced solid tumors driven by FGFR2/3 [1] Group 1: Clinical Trial Approval - APL-2401 has been approved for a Phase I clinical trial, marking a significant milestone for the company [1] - The drug is a first-class innovative medication developed globally, designed as a highly selective small molecule inhibitor targeting FGFR2/3 [1] - The approval was granted in just 22 working days, making it one of the first projects to receive approval under the new regulatory pathway established by the NMPA [1] Group 2: Potential Impact - APL-2401 aims to provide a new treatment option for patients with advanced solid tumors, including urothelial carcinoma, cholangiocarcinoma, endometrial cancer, gastric cancer, breast cancer, ovarian cancer, non-small cell lung cancer, and other specific solid tumors [1] - The clinical trial design and submission materials comply with international clinical trial technical standards, enhancing the drug's credibility and potential for success in the market [1]