Hugel Receives U.S. FDA Approval for Botulinum Toxin Letybo

• Hugel achieves the distinction of being the inaugural and sole Korean company to obtain market approvals in the three primary aesthetic markets: the U.S., Europe, and China.
• The United States stands as the foremost and swiftest expanding aesthetic market worldwide, reaching USD 2.5 billion in 2023 and projected to almost double to USD 4.9 billion by 2031.

Hugel, a global leader in medical aesthetics, has announced that it has secured marketing approval from the U.S. Food and Drug Administration (FDA) on the 29th (local time) for two variants of its botulinum toxin, Letybo: 50 units and 100 units.

The FDA's endorsement of Letybo signifies a significant validation of Hugel's product excellence and reliability, meeting the stringent criteria set by one of the world's foremost regulatory bodies. This further reinforces the company's standing as a leader in the international arena.

With this approval, Hugel became the inaugural and exclusive Korean company and one of the top three players globally to attain market endorsements in three major aesthetic markets - the United States, China, and Europe. It has thus far secured marketing approvals in 63 countries and continues to expand its global reach.

The United States represents the largest medical aesthetic market globally, commanding more than 50% of the total market share. According to data from leading global research firms, this market is anticipated to nearly double from USD 2.5 billion in 2023 to USD 4.9 billion in 2031.

Hugel is currently finalising its go-to-market strategy, with plans to commercially introduce Letybo by the middle of this year. The successful launch of Letybo in Canada last year provided a robust foundation for their entry into the North American market, paving the way for accelerated expansion into the U.S. market.

Chairman Cha stated:

"As a leading global medical aesthetic company, we are delighted to enter the United States, the world's largest and yet still fast-growing market. We believe our long-standing track record in South Korea, growing global market position and premium brand positioning, thought leadership in the field and the comprehensive medical affairs programs will create significant value to all constituents including our global customers, strategic partners and shareholders."