Hugel said Friday it obtained marketing approval for Letybo 50Unit, a botulinum toxin (BTX), from Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) on May 25.

Earlier in 2019, Hugel and Austrian pharmaceutical firm Croma began phase 3 trials of the BTX in Poland and Germany. In 2020, the company applied for approval in 11 countries in Europe.

In January this year, Hugel received the Heads of Medicines Agencies (HMA) recommendation for Letybo authorization and began the entry into the European BTX market.

In the same month, Hugel’s Letybo won the nod in France.

So far, the company’s BTX product has obtained a license in 10 European countries, including Poland.

Hugel aims to get the license for Letybo in 36 countries in Europe by next year.

In March, Hugel sent the first batch of Letybo to France and Austria, becoming the first Korean BTX maker to launch a BTX there.

“Europe is one of the three largest BTX markets, along with China and the U.S. Europe will be the key region to lead Hugel’s global growth,” an official at Hugel said. “With Hugels’ hyaluronic acid (HA) filler that has grown rapidly in the existing European market, we will seek more solid growth (of Letybo) in Europe.”