Hugel Accelerates Entry into European Botox Market

Hugel's European export botulinum toxin 'Letibo'.

[Asia Economy Reporter Kim Young-won] Hugel has officially entered the European market. Hugel, the first domestic botulinum toxin company to declare its entry into Europe, completed Phase 3 clinical trials in Poland and Germany in 2019, and submitted marketing authorization applications to 11 major European countries in June 2020.

In January of this year, Hugel received a recommendation for marketing authorization approval from the Heads of Medicines Agencies (HMA) for its botulinum toxin product "Botulax" (export name Retivo), indicated for glabellar lines.

Hugel first obtained marketing authorization in France. Although it usually takes about 1 to 3 months from receiving the HMA opinion to individual country approval, Hugel obtained approval from the French National Agency for Medicines and Health Products Safety (ANSM) just two days after receiving the opinion. Subsequently, Hugel secured approvals from 10 European countries including the UK, Germany, Austria, and Romania, alongside France.

Notably, in March, Hugel made its first shipment to Europe, launching its presence in the French and Austrian markets. Together with its local European partner, Chroma, Hugel participated in the "International Master Course on Aging Science 2022 (AMWC)" held at the Grimaldi Forum in Monte Carlo, Monaco, from March 31 to April 2, successfully achieving the official launch of a botulinum toxin formulation as the first domestic botulinum toxin company.

Having taken its first step into the European market, Hugel plans to establish market entry strategies tailored to each country's characteristics and aims to achieve a 10% market share within five years of market entry. Currently, Botox is dominated by AbbVie, Dysport by Ipsen, and Xeomin by Merz in Europe. Accordingly, Hugel plans to prioritize targeting the five major countries?UK, France, Germany, Italy, and Spain?that account for about 70% of the European market to rapidly expand its market share.

A Hugel representative stated, "Following last year's entry into China, the full-scale entry into the European market this year is realizing the company's goal of becoming a global medical aesthetic company," adding, "We plan to successfully lead market entry into the remaining European countries as well as the US, Canada, and Australia next year, spreading the status and value of 'K-toxin' to the global market."

This content was produced with the assistance of AI translation services.