Medytox said on Feb. 9 it filed a new drug application with the China Food and Drug Administration to sell its botulinum neurotoxin product Meditoxin there.
If the Seoul-based company clears the final regulatory hurdle, which typically takes one to two years, it will become the first to launch its anti-wrinkle injectable botulinum toxin in China among Korean firms.
Medytox laid the groundwork for market entry when it partnered with Hong Kong-based Bloomage BioTechnology to establish a joint venture, called Medybloom in 2015.
“Given Bloomage’s status as the biggest or second-biggest player in the Chinese dermal filler market, we expect that the joint venture will have a bigger impact than if other Korean companies decided to go it alone,” a Medytox official told The Investor.
The firm is banking on the plastic surgery boom in China to boost its revenue from overseas operations, which already account for 70 percent of total sales. “The Chinese cosmetic market, which is growing at 20-30 percent per year, is an attractive market with great growth potential,” the official said.
Currently, there are only two botulinum toxin products that are officially registered in China -- BTXA developed by the Lanzhou Institute of Biological Product of China and US Allergan’s Botox.
Medytox’s competitors Hugel and Daewoong Pharmaceuticals are currently conducting phase 3 clinical trials on their neurotoxins in China. Hugel hopes to launch Botulax in 2019 while Nabota from Deawoong is planned for a 2020 launch.
By Park Han-na (firstname.lastname@example.org