Ildong Pharmaceutical Group's Idions, Targeted Cancer Drug Designated as Orphan Drug by US FDA

Idions, a subsidiary specializing in new drug development of Ildong Holdings logo

[Asia Economy Reporter Lee Chun-hee] Idience announced on the 9th that its targeted anticancer drug candidate ‘Venadafarib (IDX-1197)’ has received orphan drug designation from the U.S. Food and Drug Administration (FDA).

Idience is a new drug development subsidiary of Ildong Holdings, the holding company of the Ildong Pharmaceutical Group. It is conducting clinical development work on new drug pipelines including Venadafarib. Venadafarib is a new drug candidate with a PARP (poly ADP-ribose polymerase) inhibition mechanism. It is being developed as a targeted therapeutic anticancer agent for solid tumors such as gastric cancer, breast cancer, and ovarian cancer.

Idience explained that based on nonclinical research data and clinical results conducted so far on Venadafarib, it recently received designation from the FDA as a treatment for rare diseases related to gastric cancer. The FDA’s orphan drug designation system is a program that designates drugs necessary for the prevention, diagnosis, and treatment of rare diseases and provides incentives to promote their development.

When designated as an orphan drug, the candidate substance can receive benefits such as clinical research support, regulatory relief, tax reductions, and exemption from application fees during the development process. Additionally, it enjoys exclusivity that prevents other drugs with the same ingredient from entering the same indication field for seven years after marketing approval.

Currently, Idience is conducting a Phase 1b clinical trial related to combination therapy for gastric cancer treatment with Venadafarib in South Korea, the United States, and China.

An Idience official said, “We expect that the orphan drug designation will accelerate clinical and approval processes related to Venadafarib and commercialization efforts. We plan to pursue multinational clinical trials aiming for a new drug application (NDA) in 2026, while also seeking cooperation partners and license-out opportunities.”