---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-070501"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2026-06-04T20:04:26+00:00"
generated_at: "2026-06-04T20:05:09.032859+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Quoin Pharma gets Japan MHLW Orphan Drug Designation for QRX003 in Netherton Syndrome

## Summary
- Japan MHLW granted Orphan Drug Designation to QRX003 lotion (4%) for Netherton Syndrome, a rare genetic skin disorder with no approved treatments.
- Designation provides incentives including up to 10 years of market exclusivity upon approval, priority review, and tax breaks.
- Adds to prior U.S. FDA Orphan Drug, Pediatric Rare Disease, and Fast Track designations, plus EMA Orphan Drug Designation.
- Quoin plans to self-commercialize QRX003 in Japan, U.S., and Western Europe; pivotal Phase 3 study expected H2 2026, NDA filing in 2027.
- Company working with Japanese clinicians to refine clinical/regulatory pathway for approval.

## SEC filing metadata
- accession: 0001104659-26-070501
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2026-06-04T20:04:26+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671502/000110465926070501/0001104659-26-070501-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465926070501/tm2616916d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-070501
- JSON: https://secwatch.observer/filing/0001104659-26-070501.json
- Plain text: https://secwatch.observer/filing/0001104659-26-070501.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.