Hugel said Tuesday that it has received sales approval from the Taiwan Food and Drug Administration for Botulax, its botulinum toxin product (BTX).
The Korean company is the first to win the go-ahead for marketing a BTX product in the island state. The company started conducting phase 1 clinical trials for its treatment in Taiwan in 2015. Hugel plans to launch the product by the end of this year and expects sales to increase at the first quarter of next year.
“The launch in Taiwan has a symbolic meaning as it can set the foundation for the advancement of the company’s product into the Chinese economic sphere,” the company said. “Taiwan is one of the top five BTX markets in Asia, which is growing more than 11 percent annually.”
There are only three overseas suppliers approved for sale in Taiwan -- Allergan, Merz, and Ipsen – and Hugel expects a market preemption effect as the first Korean company.
Also, the company has completed its phase 3 clinical trials in China earlier this year and is aiming for marketing approval at the end of next year.
“The entry into the Taiwan market is meaningful because it is a testbed to judge the entry into the Chinese market, which is one of the three major global markets,” Hugel CEO Sohn Ji-hoon said. “We plan to concentrate all possible resources with the aim of achieving 30 percent market share within three years.”
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