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

Hugel becomes the first and only Korean company that have market approvals in all three major aesthetic markets – U.S., Europe and ChinaU.S. is the largest and fastest growing aesthetic market globally at USD 2.5 bn in 2023, and expected to nearly double to USD 4.9 bn by 2031

SEOUL, South Korea, March 3, 2024 /PRNewswire/ — Hugel, a global total medical aesthetics company, announced that the company has received marketing approval from the U.S. Food and Drug Administration(FDA) on the 29th(local time) for 50 units and 100 units of its botulinum toxin Letybo.

The FDA approval of Letybo, represents a strong recognition of Hugel’s product quality and credibility, meeting the rigorous standards by one of the world’s leading regulatory authorities. It also further underscores the Company’s international leadership position.

With the approval, Hugel becomes the first and only Korean company and one of the top 3 players globally that have garnered market approvals in three major aesthetic markets—the United States, China, and Europe. To date, it has received marketing approvals in a total of 63 countries, continue to expand its global coverage.

The United States is the world’s largest medical aesthetic market, accounting for over 50% of the total market share. According to data from global research firms, the market is expected to nearly double from USD 2.5 bn in 2023 to USD 4.9 bn in 2031.

Hugel is currently in the process of finalizing the go-to-market strategy, aiming to commercially launch the product by the middle of this year. The launch of Letybo in Canada last year laid a solid foundation for our entry into the North American market, setting the stage for accelerated penetration 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.”

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SOURCE Hugel