Hugel is to become the first Korean company to enter the greater China region, which includes mainland China and Taiwan.
Hugel and its Chinese partner, Sihuan Pharm, completed phase 3 clinical trials in 2018 and submitted the application Wednesday after finalizing the paperwork.
Hugel expects to receive marketing approval within the first quarter of 2020, as the standard review process for a new drug application lasts about a year.
China’s botulinum toxin market grows roughly 25 percent each year, as compared with the 10 percent annual growth rate of the global botulinum toxin market.
Currently, China only has two approved botulinum toxin products: one from Allergan and the other from the Lanzhou Institute.
Hugel said it plans to rapidly secure market share in China through its medical aesthetic forum “Global H.E.L.F (Hugel Expert Leader’s Forum)” and through active marketing with the help of its Korean medical network in China.
“Our submission of the (new drug application) in China is a significant milestone as we begin our entry into the global market,” said Hugel’s representative.
Hugel is also anticipating approval in Europe and the US by 2021 and 2022, respectively.
By Lim Jeong-yeo (firstname.lastname@example.org)