Yahong Pharmaceutical (688176.SH): APL-2401 clinical trial application approved by the State Drug Administration

Zhitong Finance App News, Yahong Pharmaceutical (688176.SH) announced that the company received the “Drug Clinical Trial Approval Notice” issued by the National Drug Administration (NMPA), and the company's application for APL-2401 (drug name is ASN-8639 tablets) to conduct phase I clinical trials in patients with advanced solid tumors driven by FGFR2/3 was approved.

According to the announcement, APL-2401 is a class 1 innovative drug developed simultaneously around the world. Its international multi-center clinical trial design and application data meet the requirements of the international clinical trial technical standard system, successfully included in the “30-day channel” stipulated in the “Notice on Optimizing the Evaluation and Approval of Innovative Drugs (No. 86 of 2025)” issued by the State Drug Administration on September 12, 2025, and was approved in just 22 working days, making it one of the first batch of projects in the country to be approved by this new policy.