Quoin Advances Global Regulatory Strategy with Japan Orphan Drug Submission for QRX003
Quoin Pharmaceuticals (Nasdaq: QNRX) announced that it has submitted an application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orphan Drug Designation (ODD) for QRX003, its lead late-stage topical product candidate for the treatment of Netherton Syndrome.
Following a successful meeting with the MHLW, the agency confirmed that QRX003 qualifies for both Orphan Drug Designation and Fast Track regulatory review status in Japan. If granted, the designation would extend orphan drug status for QRX003 across all three of Quoin’s core commercial territories: the United States, Europe, and Japan.
Japan’s Orphan Drug Designation program is designed to support the development and approval of treatments for rare diseases affecting fewer than 50,000 patients nationwide. Benefits associated with the designation include eligibility for research and development subsidies, tax incentives for qualified clinical activities, reduced regulatory fees, priority review, and up to ten years of market exclusivity following approval.
According to the company, QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome, a devastating, life-long genetic skin disorder with no approved treatments. Confirmation from the MHLW that QRX003 also qualifies for Fast Track review could further accelerate the regulatory pathway in Japan, subject to approval of the application.
In parallel with the regulatory submission, Quoin announced plans to establish a Japanese subsidiary to support potential self-commercialization of QRX003 in the region, reflecting the company’s intention to build a sustainable commercial presence in one of the world’s largest pharmaceutical markets.
“Following a successful meeting with MHLW, we are optimistic that QRX003 will be granted ODD status in Japan. We are also pleased to learn that MHLW has confirmed QRX003 will also qualify for Fast Track regulatory review status in Japan,” said Dr. Michael Myers, CEO of Quoin Pharmaceuticals.
QRX003 lotion (4%) is currently being evaluated in two late-stage, whole-body pivotal clinical trials for the treatment of Netherton Syndrome. Enrollment in both studies is expected to be completed in the first half of 2026, with top-line data anticipated in the second half of the year. Subject to successful clinical outcomes, Quoin plans to submit a New Drug Application in the United States and other territories in late 2026 or early 2027.
In 2025, QRX003 was granted Orphan Drug Designation by both the U.S. Food and Drug Administration and the European Medicines Agency, further supporting its global regulatory positioning as Quoin advances toward potential first-in-class approval.
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