Hugel Obtains Polish Marketing Authorization for Botulinum Toxin Product 'Botulax'

Approved in 10 European Countries... Targeting Expansion to 36 Countries Next Year

Hugel Geodugong Factory Exterior.

[Asia Economy Reporter Lee Gwan-joo] Hugel announced on the 3rd that it has obtained product approval from the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) for the botulinum toxin preparation 'Botulex' (export name Retivo) 50 units (Unit) indicated for glabellar wrinkles.

Earlier, in 2019, Hugel, together with the Austria-based medical aesthetic pharmaceutical company 'Croma', started Phase 3 clinical trials in Poland and Germany aiming to enter the European market, and in 2020 submitted product approval applications to 11 major European countries. Subsequently, in January this year, it received a recommendation for product approval from the Heads of Medicines Agencies (HMA) in Europe, marking the start of its full-scale entry into the European market.

Starting with France in the same month, Hugel has completed approvals in a total of 10 European countries including the UK, Germany, Italy, and now Poland, and aims to enter 36 European countries by next year. In March, it made its first shipment to France and Austria, launching Botulex in the local market as the first domestic botulinum toxin company to do so.

A Hugel official said, “Europe, along with China and the United States, accounts for the vast majority of the global botulinum toxin market,” adding, “Together with Hugel’s hyaluronic acid (HA) filler products, which have shown rapid growth in the existing European market, we plan to accelerate efforts for faster growth within the European market.”

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