'53 domestic biopharmaceutical sites designated as FDA orphan drugs'

23-02-15

[Press Nine] It was found that there are 53 domestic pharmaceutical and bio companies that have received Orphan Drug Designation (ODD) designation from the US Food and Drug Administration (FDA).

When designated as an orphan drug by the FDA, it receives benefits such as tax cuts, research subsidies, marketing exclusivity, expedited review, and exemption from review costs. In addition, after the completion of the phase 2 clinical trial, the path to obtain conditional approval will be opened.

According to the industry on the 14th, 'Hanmi Pharm', which received 6 orphan drug designations from the FDA, obtained the most rare drug approvals.

'PRG S&T' followed with 4 cases. 'Immunophage', 'GC Cell', and 'Medpacto' each had three cases each, indicating a relatively high number of FDA orphan drug designations.

There are nine companies designated by the FDA as two orphan drugs: LG Chem, Daewoong Pharmaceutical, Qurient, Alteogen, Neuramedi, Biopharm Solutions, Genexine, GC Green Cross, and Pharos iBio.

Others ▲Canaria Bio ▲Samjin Pharmaceutical ▲Apta Bio ▲Immunomet Therapeutics ▲HLB ▲CrystalGenomics ▲Qurient ▲Idians ▲Future Medicine ▲BioLeaders ▲Nzychem Life Sciences ▲First Biotherapeutics ▲Antrogen ▲Boryeong ▲Bridge Biotherapeutics ▲Cellatoz Therapeutics ▲Chong Kun Dang ▲Corestem ▲Curom Bioscience ▲GI Innovation ▲GNT Pharma ▲HanAll Biopharma ▲Intron Biotechnology ▲LegoChem Bioscience ▲Mezzion ▲Nuroventi ▲On A total of 39 companies, including Konic Therapeutics, Oscotec, PharmAbcine, Shinpoong Pharmaceutical, Sillajen, and Eupexmed, received approval for one orphan drug each.

Recently, 'KF1601', which is being developed by ImmunoForge, obtained approval as an orphan drug (January).

The FDA has designated KF1601 as an orphan drug for chronic myeloid leukemia (CML).

In addition, Immunophage received orphan drug designation for indications for polymyositis (PF1801, October 2021) and Duchenne muscular dystrophy (PF1801, December 2020).