Hugel said that the EU's Heads of Medicines Agencies (HMA) has issued a positive opinion for the approval of Letybo, its botulinum toxin (BTX) product, for treating forehead wrinkles.
HMA is an association of drug safety management organizations in each European country.
The company expects to enter into 11 European markets, including the top five – U.K., Germany, Italy, France, and Spain -- which account for 70 percent of the regional market. The first shipment to Europe is expected to be made in the first quarter after obtaining approval from individual countries.
Hugel also plans to follow up on the registration process in other European countries soon.
Hugel submitted the product approval application in the 11 European countries in June 2020 after completing two phase 3 clinical trials -- Bless 1 and 2 -- in Germany and Poland in 2019 in partnership with Croma Pharma, an Austria-based pharmaceutical company.
In November, the company also completed its final step before entering the final stage of European market entrance after receiving the good manufacturing practice (GMP) certificate for its plant.
Hugel plans to conduct localized marketing activities with Croma Pharma to penetrate the European market. Croma Pharma specializes in medical aesthetics with a wide portfolio of HA fillers, skin care products, lifting threads, and PRP devices.
Hugel expects Croma to conduct strategic marketing activities based on its sales network in 10 major European countries and 40 years of accumulated marketing experience.
Croma is distributing Saypha, its filler product, in more than 60 countries globally, and Hugel expects to benefit from the synergy between Letybo and Saypha.
The two companies aim to achieve more than 10 percent market share in Europe within five years of the launch.
"Hugel's botulinum toxin has maintained its top market share position in Korea for six consecutive years, and the company proved its product excellence and growth potential into the global markets by becoming the first Korean botulinum toxin company to enter into China and achieving 10 percent market share in its first year of launch," Hugel CEO Sohn Ji-hoon said.
The company will contribute to the presence and reputation of the Korean biopharmaceutical industry by quickly penetrating the European market and satisfying the needs of both consumers and medical aesthetics practitioners around the world, he added.
The European botulinum toxin market, estimated to be worth around 500 billion won ($417.7 million), is one of the three primary markets that account for 80 percent of the global botulinum toxin market, along with China and the U.S.
According to Hugel, the consumers’ ages have been diversifying, and the number of male consumers has been continuously increasing in the EU, where interest and demand for medical aesthetic procedures are rapidly growing amid increasing exposure to social media.