Supports Quoin's planned direct commercialization of QRX003 in Japan, one of its three core commercial territories
Follows recent grant of Orphan Drug Designation to QRX003 by Japan's MHLW
ASHBURN, Va., June 18, 2026 (GLOBE NEWSWIRE) -- 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 it has completed the establishment of a wholly-owned subsidiary in Japan as part of its strategy to directly commercialize QRX003 for the treatment of Netherton Syndrome, if approved. The formation follows the recent grant of Orphan Drug Designation to QRX003 by Japan's Ministry of Health, Labour and Welfare (MHLW) and supports Quoin's long-term commercial plans in one of its three core markets.
A local corporate presence allows Quoin to engage directly with Japanese regulators, clinicians, and patient advocacy organizations as it builds the commercial infrastructure to support a potential launch. Japan is one of Quoin's core territories, along with the United States and Western Europe, in which Quoin intends to self-commercialize QRX003 and its other pipeline products. Outside of these territories, Quoin has established nine commercial partnerships for QRX003 spanning sixty one countries, which combined with the company's core territories, could facilitate almost global availability of the product if approved.
QRX003 has now received Orphan Drug Designation for Netherton Syndrome in the United States, the European Union, and Japan, providing development and commercial incentives across all three of Quoin's core commercial territories.
"Establishing our Japanese subsidiary is another important step forward in our plan to self-commercialize QRX003 in one of our three core markets and follows the earlier establishment of Quoin Therapeutics, Ireland, our Western European subsidiary," said Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals. "With Orphan Drug Designation now secured in the United States, Europe, and Japan, we are continuing to build the commercial infrastructure in advance of a potential approval. Establishing our presence in Japan now reflects both our confidence in QRX003 and our long-term commitment to this very attractive market."
QRX003 lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin's pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027. If approved, QRX003 has the potential to become the first approved treatment for Netherton Syndrome. Quoin is working closely with leading Japanese clinicians to refine the clinical and regulatory pathway for approval of QRX003 for the treatment of Netherton Syndrome.
About Netherton Syndrome
Netherton Syndrome is a rare, inherited skin disorder caused by mutations in the SPINK5 gene, leading to severe skin barrier dysfunction, chronic inflammation, and a heightened risk of infections and allergic complications. Patients often experience widespread skin redness, scaling, persistent itching, and significant impairment in quality of life. There are currently no FDA-approved therapies for the treatment of Netherton Syndrome, and treatment options are limited to supportive care and off-label therapies.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities, and care teams. Quoin's innovative pipeline is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, microcystic lymphatic malformations, venous malformations, angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
Forward-Looking Statements
The Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as "expect," "intend," "hope," "plan," "potential," "anticipate," "look forward," "believe," "may," and "will," among others. This press release contains forward-looking statements. All statements that reflect the Company's expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: Quoin's strategy to directly commercialize QRX003 for the treatment of Netherton Syndrome, if approved; engaging directly with Japanese regulators, clinicians, and patient advocacy organizations as Quoin builds the commercial infrastructure to support a potential launch; self-commercializing QRX003 and the Company's other pipeline products in Japan, the United States and Western Europe; facilitating almost global availability of the product if approved; continuing to build the commercial infrastructure in advance of a potential approval; initiating Quoin's pivotal Phase 3 study in the second half of 2026, with a potential NDA filing in 2027; QRX003 having the potential to become the first approved treatment for Netherton Syndrome; working closely with leading Japanese clinicians to refine the clinical and regulatory pathway for approval of QRX003 for the treatment of Netherton Syndrome; and Quoin's products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company's ability to pursue its regulatory strategy; the Company's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company's ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
For further information, contact:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
