Huons Global said Tuesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) to go ahead with domestic phase 3 clinical trials for Hutox, a botulinum toxin (BTX) strain used for forehead wrinkle treatment.
Hutox is a BTX strain developed by Huons’ research institute. It has excellent fermentation productivity and high purification technology and uses ATCC3502 strain, which is different from other domestic companies.
The approval came after Huons successfully finished phase 1 and phase 2 clinical trials for treating adults with a moderate or severe improvement of wrinkles in June. The tests proved the safety and efficacy of the treatment against forehead wrinkles.
“Currently, the BTX market is worth 4 trillion won ($3.5 billion) in worldwide, and 100 billion won in Korea,” said Kim Wan-seop 김완섭, CEO of Huons Global 휴온스 글로벌. “The company plans to complete phase 3 trials and enter the domestic market in the first quarter of 2019.”
The company is also aiming to expand global sales. The company has exported Hutox to some countries after it received approval for export at the end of last year.
Huons Global is building a second factory that complies with EU and U.S. GMP factory regulations to expand their global market. The second plant, located in North Chungcheong Province, will complete its construction in the first half of 2018. The new plant will expand production capacity by five times compared with the current production volume and produce more than 3 million vials annually.
<© Korea Biomedical Review, All rights reserved.>