亚虹医药APL-2401临床试验申请获批准

Group 1 - The core point of the article is that Yahui Pharmaceutical (688176) 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] - APL-2401 is a globally developed innovative drug classified as a Class 1 new drug, and its clinical trial design and application materials meet international clinical trial technical standards [1] - The approval process for APL-2401 was expedited under the new policy announced by the NMPA on September 12, allowing for a review period of only 30 days, and the approval was granted in just 22 working days, making it one of the first projects to receive approval under this new regulation [1]