Quoin Pharmaceuticals Submits Orphan Drug Designation Application To Japan's MHLW For QRX003 To Treat Netherton Syndrome

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 following a successful meeting with the Japanese MHLW that it has submitted an application for Orphan Drug Designation (ODD) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome. At the meeting, the MHLW confirmed that QRX003 qualifies for both ODD and Fast Track regulatory review in Japan. If granted, QRX003 will have ODD status in Quoin's three core commercial territories of the US, EU and Japan.

The MHLW's Orphan Drug Designation program provides orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 50,000 people in Japan. This designation provides certain benefits, including R&D subsidies, tax credits for qualified clinical testing, reduction of MHLW application fees, priority review and ten years of market exclusivity, if approved. QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome.