Alphamab Oncology (9966) announced that its investigational drug JSKN003 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This milestone extends to cases not restricted by HER2 expression.

According to the announcement, JSKN003 has also received U.S. FDA approval for a phase II clinical trial in this indication. In China, the Centers for Drug Evaluation has granted Breakthrough Therapy Designations for JSKN003 targeting the same indication, as well as colorectal cancer. Additionally, it has received Orphan Drug Designation in the U.S. for gastric cancer and gastroesophageal junction cancer.

Latest trial data, presented at the 2025 Annual Meeting of the American Society of Clinical Oncology, included 46 patients with platinum-resistant recurrent epithelial ovarian cancer. Among all patients, the objective response rate was 63.0%, with a median progression-free survival of 7.7 months. In patients with HER2 IHC 1+, 2+, and 3+, the objective response rate rose to 72.2%, and median progression-free survival reached 9.4 months.

JSKN003 is described as a biparatopic HER2-targeting antibody-drug conjugate that employs site-specific conjugation for enhanced stability, facilitating potent antitumor activity across HER2-expression tumors. Alphamab Oncology highlights the significant unmet clinical need and expects that this Fast Track Designation will further expedite JSKN003’s global clinical development and regulatory review.