Botanix Pharmaceuticals (ASX:BOT) has welcomed news that its partner Dongwha Pharm has secured regulatory approval for ECCLOCK gel, 5% (sofpironium bromide) in South Korea, paving the way for the product’s commercial launch in the first quarter of 2026.
The approval, granted by South Korea’s Ministry of Food and Drug Safety on 29 August 2025, follows a two-year process that began when Dongwha submitted its application in September 2023.
ECCLOCK will be manufactured at Kaken Pharmaceutical’s Shizuoka plant in Japan and distributed in Korea under a sublicense and distribution agreement signed between Kaken and Dongwha in June 2023.
Kaken first introduced ECCLOCK to the Japanese market in November 2020, marking the drug’s commercial debut. Now, with the South Korean approval in hand, Dongwha will add the treatment to its broad portfolio of prescription and over-the-counter medicines. Founded in 1897, Dongwha is Korea’s oldest pharmaceutical company and remains one of its most established players, reporting revenues of 464.87 billion South Korean Won in 2024.
>ECCLOCK represents a significant advance for patients, offering a topical treatment option in the dermatology field. While Kaken holds rights to commercialise ECCLOCK across several Asian markets, including South Korea and China, Botanix has structured the agreement to capture a portion of the royalties. Under the terms of the arrangement, Botanix will receive 50 per cent of the royalties Kaken earns from Dongwha’s net sales in Korea, while 55 per cent of Botanix’s share will flow to the drug’s originator.
Botanix cautioned that revenues from the South Korean sublicense agreement are not expected to be material at this stage. However, the company emphasised the importance of the approval as a milestone in ECCLOCK’s international rollout and as validation of its commercial strategy. Beyond Asia, Botanix retains the right to sublicense sofpironium bromide in all territories outside the United States, with the potential for upfront income, milestone payments, and royalties to contribute to its future growth.
The company is positioning ECCLOCK’s progress in Korea as part of a broader strategy to expand the drug’s global footprint. For Botanix, the South Korean approval underscores its ability to leverage regional partnerships while maintaining flexibility to strike additional deals across other international markets.