Yahong Pharmaceutical (688176.SH): APL-2401 clinical trial application approved by the National Medical Products Administration.

Yahong Pharmaceuticals (688176.SH) announced that the company has received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA). The company's APL-2401 (drug name ASN-8639 tablets) has been approved for Phase I clinical trials in patients with FGFR2/3-driven advanced solid tumors. The announcement states that APL-2401 is a Class 1 innovative drug developed globally. Its international multicenter clinical trial design and application materials meet the requirements of international clinical trial technical standards. It has been included in the "30-day channel" stipulated in the Announcement on Optimizing the Review and Approval of Innovative Drug Clinical Trials issued by the NMPA on September 12, 2025 (No. 86 of 2025), and received approval in just 22 working days, becoming one of the first projects in the country to receive approval under this new policy.