Bio & Pharma
Jetema applies to test its botulinum toxin in US from July
S.Korea's company seeks FDA approval of phase 2 clinical tests and to build a filler plant in America within 4 years
By Feb 27, 2023 (Gmt+09:00)
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South Korea's bio-esthetic pharmaceutical company Jetema Co. will hold clinical trials in the US to advance to the American market, the world's biggest for botulinum toxin, aka Botox.
"We plan to apply with the US Food and Drug Administration to conduct phase 2 clinical trials in July," said CEO Jae Young Kim on Sunday. The company will hold the trials through its American subsidiary, with the opening of Jetema USA expected to come soon.
In 2017, Jetema introduced a botulinum toxin strain from the now-defunct British agency Public Health England and released the toxin's genetic sequence. The Jetema strain of ATCC 3502 is like those of global pharmaceutical companies like Merz and Ipsen.
Jetema is also preparing to launch on the American market its filler eptq, the company's main product that accounts for 80% of sales. Last year, the company posted 46 billion won ($34.8 million) in sales, up 38.4% from 2021, and 4.4 billion won in operating profit, up 92.1%.
Jetema also plans to build a filler plant in the US over the next four years. "We understand that no place in the US has a filler plant owned by a large global pharmaceutical company," it said. "Jetema will grab the title of the 'world's first' filler production in the US."
Write to Yoorim Kim at youforest@hankyung.com
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