Quoin Pharmaceuticals Announces Submission to Japanese MHLW for Orphan Drug Designation for QRX003 in Netherton Syndrome

Core Viewpoint - Quoin Pharmaceuticals has received confirmation from the Japanese MHLW that its lead product candidate QRX003 qualifies for both Orphan Drug Designation and Fast Track regulatory review in Japan, aiming to self-commercialize the product if approved [1][3]. Group 1: Regulatory Designation - QRX003 has been granted Orphan Drug Designation by both the U.S. FDA and the European Medicines Agency in 2025, and is now seeking similar status in Japan [1][2]. - The MHLW's Orphan Drug Designation program offers benefits such as R&D subsidies, tax credits for clinical testing, reduced application fees, priority review, and ten years of market exclusivity if approved [2]. Group 2: Clinical Development - QRX003 lotion (4%) is currently being evaluated in two late-stage pivotal clinical trials for Netherton Syndrome, with enrollment expected to be completed in the first half of 2026 [3]. - Top-line data from these trials is anticipated in the second half of 2026, with a New Drug Application (NDA) submission planned for late 2026 or early 2027 [3]. Group 3: Company Strategy - The company plans to establish its own commercial infrastructure in Japan, which is one of the three core territories for QRX003 and other pipeline products [3]. - Quoin Pharmaceuticals is committed to completing the clinical development of QRX003 urgently to address the needs of patients suffering from Netherton Syndrome [3].