Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) has established a wholly-owned subsidiary in Japan as part of its plan to directly commercialize QRX003, a treatment candidate for Netherton Syndrome, if the drug receives regulatory approval.

The subsidiary formation follows Japan's Ministry of Health, Labour and Welfare granting Orphan Drug Designation to QRX003. The drug has now received Orphan Drug Designation in the United States, the European Union, and Japan — covering all three of Quoin's core commercial territories.

Japan joins the U.S. and Western Europe as markets where Quoin intends to self-commercialize QRX003. The company previously established Quoin Therapeutics Ireland as its Western European subsidiary. Outside these three territories, Quoin has entered into nine commercial partnerships covering 61 countries.

"Establishing our Japanese subsidiary is another important step forward in our plan to self-commercialize QRX003 in one of our three core markets," said Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals.

QRX003, a 4% lotion, is currently being evaluated in Phase 2 whole-body clinical trials for Netherton Syndrome. Quoin said it expects to initiate a pivotal Phase 3 study in the second half of 2026, with a potential NDA filing targeted for 2027. There are currently no FDA-approved therapies for Netherton Syndrome.

The information in this article is based on a press release issued by Quoin Pharmaceuticals.