Hugel has filed a new drug application (NDA) for Botulax, its botulinum toxin (BTX) brand, to the China Food and Drug Administration (CFDA).
The company said that it submitted the NDA after completing phase 3 clinical trials with Sihuan Pharmaceutical, the company’s Chinese partner, in 2018. Considering that the standard review process for an NDA lasts about 12 months, Hugel expects to receive marketing approval within the first quarter of 2020.
Once the approval takes place, Hugel will become the first Korean company to enter the market of the Greater China Region, which includes mainland China and Taiwan. For China alone, Medytox is likely to become the first Korean company to export its BTX product in the country, as it submitted an NDA in February last year and expects to receive approval in the fourth quarter of this year.
"China’ botulinum toxin market is very attractive, showing about 25 percent growth annually, as compared to 10 percent growth rate of the global botulinum toxin market," the company said.
Based on Hugel’s proven product stability and price competitiveness, it is expected the company seeks to carve out a substantive share of the Chinese market, it added. Currently, there are only two BTX products available in China -- Lanzhou Biological Products Institute BTX-A and Allergen’s Botox.
Hugel plans to secure market share in China rapidly not only through its medical aesthetic forum, "Global H.E.L.F (Hugel Expert Leader’s Forum)" but also through active marketing in China with the help of the Korean medical network.
“Our submission of the NDA in China is a significant milestone as we begin our entry into the global market,” the company official said. “Hugel is also expecting approval in Europe and the U.S. by 2021 and 2022, respectively. With successful entry to the major markets within the next three years, we’ll have the opportunity to expand our global footprint and attain continuous sales growth.”
Hugel has expanded its market share and experienced the sales growth of Botulax in 26 countries, including Russia and Brazil, it said. The company also expects to generate meaningful sales in Taiwan starting from the second quarter of this year.