Huons Global said that China’s National Medical Products Administration Center for Drug Evaluation has approved its investigational new drug (IND) application for Hutox, the company’s botulinum toxin (BTX) product that treats forehead wrinkles, last Thursday.
Huons' BTX Hutox
e company submitted its application in February.
Huons Global said it would confirm the effectiveness of the treatment in improving moderate or severe forehead wrinkles through phase 3 clinical trials in China.
The company has been exporting the treatment to various countries around the world and completed phase 1, 2, and 3 clinical trials for forehead wrinkle improvement in Korea, under the brand name Liztox.
The company plans to advance into the Chinese market as soon as possible by completing phase 3 clinical trials by 2021 and obtain sales approval from the Chinese authorities the following year.
“With the IND approval, our entry into the Chinese market will get on the full swing,” Huons Global CEO Kim Wan-sup said. “As Hutox has completed all clinical procedures in Korea and collected necessary data, we will be able to conduct phase 3 clinical trials in China with few problems, and make a successful entry into the Chinese market.”
As part of its efforts to accelerate the BTX’s launch in China, the company selected Imeik Technology Development, a Chinese aesthetic firm, as a partner in September 2018, and signed a local exclusive supply contract for the next decade.
According to Huons, Imeik Technology Development has established a cooperative relationship with more than 3,000 plastic surgery and dermatology clinics across China.
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