https://www.ajpharm.com/news/index/2/208?lang=en

2025-10-22

AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for AJ201, the first-in-class for therapy for spinal and bulbar muscular atrophy (SBMA, also known as Kennedy’s disease).

“Receiving the Fast Track Designation for AJ201 marks a significant milestone for AnnJi,” said Dr. Wendy Huang, CEO and Chairperson of the Board of AnnJi. “Alongside the Orphan Drug Designations granted by both the U.S. FDA and EMA, this recognition reinforces AJ201’s potential to address the unmet needs of patients with SBMA. Backed by a strong global patent portfolio, we remain committed to advancing AJ201 into Phase 3 development and to working closely with the FDA to potentially deliver the first approved treatment for SBMA in more than two decades.”