ALPHAMAB-B (09966) announced that JSKN003 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers (collectively referred to as PROC), regardless of human epidermal growth factor receptor 2 (HER2) expression levels. This marks another significant milestone in the global development of JSKN003.

Additionally, JSKN003 has received FDA approval to initiate a Phase II clinical trial for PROC patients irrespective of HER2 expression status. The drug has also been awarded Breakthrough Therapy Designation by China's Center for Drug Evaluation (CDE) for PROC and colorectal cancer (CRC), as well as Orphan Drug Designation by the FDA for gastric/gastroesophageal junction cancer (GC/GEJ).

A Phase III clinical trial for JSKN003 in PROC patients, regardless of HER2 expression, is currently progressing smoothly in China. The FTD further underscores international regulatory confidence in JSKN003's clinical potential and its significance as a novel therapeutic candidate.