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[2019.04.24] Hugel, Inc. Announces Submission of New Drug Application in China

Hugel, Inc. Announces Submission of New Drug Application in China

- Approval expected in 1Q 2020

-Hugel to be the first Korean company to enter the Greater China Region

Hugel finally begins its entry to the Greater China Region

Hugel, Inc. (145020.KQ) today announced that it has submitted a New Drug Application (NDA) in China for its botulinum toxin product.

Hugel and its Chinese partner, Sihuan Pharm, have successfully completed phase 3 clinical trials in 2018 and submitted NDA today after finalizing the paperwork. Considering that the standard review process for a NDA lasts about 12 months, Hugel expects to receive marketing approval within the first quarter of 2020. Once the approval takes place, Hugel is to become the first Korean company to enter the market of the Greater China Region, which includes mainland China and Taiwan.

China’ botulinum toxin market is very attractive in that it shows approximately 25% growth each year, as compared to 10% growth rate of the global botulinum toxin market, and there are only two approved botulinum toxin products; one from Allergan and the other from the Lanzhou Institute. Based on its proven product stability and price competitiveness, it is expected that Hugel will carry out a strategy to secure a successful Chinese market.

Hugel plans to rapidly secure market share in China 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,” said the company official. “Hugel is also expecting approval in Europe and the US by 2021 and 2022, respectively. With successful entry to all the major markets within the next 3 years, we’ll have the opportunity to greatly expand our global footprint and experience continued sales growth.”

Meanwhile, Hugel has continued to expand its market share and experience sales growth of Botulax in 26 export countries. In addition to steadily increasing sales in Russia and Brazil, the company also expects to generate meaningful sales in Taiwan, starting from this second quarter.  


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