Hugel's botulinum toxin Letibo (domestic name Botulex) has received approval from the U.S. Food and Drug Administration (FDA). With this foothold in the world's largest market, the United States, it has now entered all three of the world's major markets: Europe, China, and the U.S.
Hugel announced on the 4th that it obtained FDA approval for Letibo 50 units and 100 units on the 29th (local time). The indication approved is for the temporary improvement of moderate to severe glabellar lines related to the activity of the corrugator and procerus muscles. This is the second FDA approval for a domestic toxin following Daewoong Pharmaceutical's Jeuveau (domestic name Nabota) in 2019.
This approval marks success on the third attempt since the first FDA challenge in March 2021. The first attempt required supplementation due to issues with additional equipment added to the factory and literature and data related to the approval. The second attempt in October of the following year also required supplementation related to factory management. After addressing all related issues, the re-application in October last year led to this successful approval.
With this approval, Letibo has become the first domestic product to enter all three major global toxin markets: Europe, China, and the U.S. Globally, it is the third product to do so. The global toxin market is estimated to be worth $7.2 billion (approximately 9.6 trillion KRW), with North America, including the U.S., accounting for more than half of the market share, making it the largest market worldwide. Currently, the U.S. botulinum toxin market includes five leading products: Botox (AbbVie), Dysport (Ipsen/Galderma), Xeomin (Mertz), Jeuveau, and Daxxify (Revance).
Hugel plans to launch Letibo in the U.S. market by mid-year. Since Hugel has a local subsidiary, Hugel America, direct sales were expected. However, the company stated in its announcement that it will establish a sales strategy tailored to the local market characteristics with a local partner and will proceed with consignment sales. Jaeju Wi, a researcher at Korea Investment & Securities, analyzed, "Direct sales involve high costs," and "Considering the case of Evolus (Jeuveau's sales partner), the preferred partner for co-sales is likely to be a U.S. company."
A Hugel representative said, "We are very pleased to be able to launch Letibo in the U.S., the world's largest and fastest-growing market," adding, "We will build a differentiated position in the industry by adding value based on the outstanding performance and leadership demonstrated domestically, as well as integrated academic programs."
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