Shenzhen, China, November 3, 2025 — SHENZHEN IONOVA LIFE SCIENCE CO., LTD. (hereinafter referred to as "IONOVA") today announced that its self-developed, novel CYP11A1 inhibitor, INV-9956, has been granted Fast Track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced metastatic castration-resistant prostate cancer (mCRPC). The designation is expected to accelerate the clinical development and regulatory review of INV-9956, potentially enabling earlier patient access.
Fast Track is an FDA program designed to facilitate development and expedite review for therapies targeting serious conditions with unmet medical needs. Benefits of Fast Track may include more frequent interactions with FDA, more frequent written communications, rolling review of marketing submissions, and potential eligibility for priority review if relevant criteria are met.
About INV-9956
INV-9956, a potent, selective, and orally bioavailable CYP11A1 inhibitor, is an investigational candidate for the treatment of castration-resistant prostate cancer (CRPC). The investigational candidate has exhibited a superior overall profile in preclinical studies. IONOVA previously announced that the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) cleared IND application for INV-9956. The Phase I/II clinical trials of INV-9956 are currently ongoing.
About IONOVA
IONOVA is a clinical-stage biotech company dedicated to developing next-generation cancer therapeutics that offer distinct clinical benefits and global competitiveness.
