Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) ("Quoin" or the "Company"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation to QRX003 for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments.

The MHLW grants Orphan Drug Designation to medicines intended to treat rare diseases that affect fewer than 50,000 patients in Japan and for which there is high unmet medical need. The designation provides certain development incentives, including prioritized consultation, reduced consultation and application fees, tax incentives, priority review of applications, and up to 10 years of market exclusivity upon approval.

The MHLW designation adds to the global regulatory recognition QRX003 has received for Netherton Syndrome, which includes Orphan Drug Designation, Pediatric Rare Disease Designation, and Fast Track Designation from the U.S. Food and Drug Administration, and Orphan Drug Designation from the European Medicines Agency. Quoin has also filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority.