[Special Stock] Ildong Pharmaceutical Rises on US FDA Orphan Drug Designation for Pulmonary Fibrosis New Drug

Ildong Pharmaceutical is showing strong performance in the early trading session. It appears that buying sentiment surged after its pulmonary fibrosis drug was designated as an orphan drug by the U.S. Food and Drug Administration (FDA).

As of 9:10 AM on the 14th, Ildong Pharmaceutical is trading at 12,230 KRW, up 890 KRW (7.85%) from the previous trading day.

The day before, the Ildong Pharmaceutical Group announced that its new drug research and development subsidiary, iLeadBMS, received orphan drug designation (ODD) from the FDA for its new drug candidate ‘IL21120033’ targeting idiopathic pulmonary fibrosis (IPF).

The FDA grants orphan drug status to drugs intended to treat diseases or conditions affecting fewer than 200,000 people in the U.S., where it is expected that the costs of development or recovery of investment within seven years after FDA approval will not be feasible.

When designated as an orphan drug, benefits include a 50% tax credit on research and development (R&D) expenses, clinical development grants, and approximately a 25% orphan drug tax credit (ODTC) on clinical trial costs within the U.S. for the approved indication. Additionally, a seven-year market exclusivity period is granted post-approval.