Humedix said Thursday that its single-shot formulation Humia for osteoarthritis has obtained Conformite Europeenne certification, and the company would speed up marketing the new medicine in global markets.

Humedix said Thursday that its one-shot injection Humia for osteoarthritis has obtained Conformite Europeenne (CE) certification.
Humedix said Thursday that its one-shot injection Humia for osteoarthritis has obtained Conformite Europeenne (CE) certification.

According to the company, osteoarthritis patients have only need to take one Humia shot per six months. Considering that existing osteoarthritis medicines require three or five injections once a week, the new drug will significantly reduce hospital visits.

The company said the CE mark implies that Humia has won recognition for the technology, quality, and efficacy in the European pharmaceutical market. Pharmaceutical companies have to acquire the CE mark for marketing their products in Europe. The medicines have to meet European Union’s rigid quality, efficacy, durability, and safety requirements.

Humedix made Humia’s structure similar to the synovial fluid of healthy people by grafting high-purity hyaluronic acid technology to its original biotechnology applied with biopolymer.

The Ministry of Food and Safety approved the drug in 2019, and the company has since marketed it as Hihyalonce in Korea.

“Humia is a product developed with our biopolymer biotechnology and has won recognition for convenience and excellent therapeutic efficacy in Korea,” Humedix CEO Kim Jin-hwan said. “We will focus on overseas marketing to lead the global hyaluronic acid-based osteoarthritis drug market estimated to reach about 25 trillion won ($22.3 billion).”

The company also has been receiving royalty payments since it signed a technology transfer deal with China’s drug developer Haibin in 2015.

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