【South Korea】Hugel's Toxin 'Botulax' Goes Global: From South Korea to the World

Hugel's flagship botulinum toxin product, Botulax (export name: Letibo), is expanding beyond the domestic market into the global arena. Used for wrinkle improvement and other indications, Botulax covers five indications spanning aesthetic and therapeutic areas, with a diverse dosage lineup. Leveraging its production and quality management expertise, the product has entered markets in China, Europe, and the United States. Botulinum toxin is a biopharmaceutical that temporarily reduces muscle movement, used for wrinkle improvement or muscle spasticity relief. Botulax is Hugel's brand name for this toxin; it is sold as Botulax in South Korea and as Letibo overseas. Hugel succeeded in purifying botulinum toxin protein in 2003, continued product development, and officially launched Botulax in 2010. Currently, Botulax is used for five indications: blepharospasm, glabellar lines, post-stroke upper limb spasticity, equinus deformity due to pediatric cerebral palsy, and crow's feet. Botulax's competitiveness lies in its range of indications and dosage options. It covers both aesthetic and therapeutic indications and offers a variety of dosage forms, allowing clinicians to choose the appropriate dose based on the treatment area and purpose. Notably, the 300-unit product is the only such dosage available in South Korea for Botulax, expanding options for therapeutic use or large-area treatments. Hugel has supplied Botulax based on its in-house production and quality management system. Since botulinum toxin is a biopharmaceutical derived from purified microbial proteins, the entire process—strain management, toxin production, purification, and quality control—is critical. Manufacturing processes and quality management levels directly impact product reliability. Hugel produces the active ingredient, botulinum toxin type A protein, in-house. According to industry sources, botulinum strains and toxins are regulated under the Biological Weapons Convention, making manufacturing, possession, and import/export procedures stringent. Establishing a stable production system itself acts as a market entry barrier. Hugel handles R&D and production of botulinum toxin at its headquarters and supplies Botulax through domestic and international sales organizations. Domestically, it manages accounts by dividing channels between clinics and general hospitals. Overseas, it has continued facility approvals and modification procedures in line with each country's regulatory standards. This approach is seen as the foundation for expanding Botulax's overseas approvals based on domestic sales experience. **Overseas Market Diversification: US, Europe, China** After establishing itself as the leading product in the domestic market, Botulax accelerated overseas expansion. According to industry data, Botulax has maintained its lead in the South Korean botulinum toxin market since 2016. Building on this, it has increased approvals and sales countries, now entering major global toxin markets including the US, Europe, and China. In 2020, Hugel became the first South Korean company to receive a botulinum toxin sales license in China. It launched Letibo in the Chinese market in 2021. According to Hugel, Letibo achieved a 10% market share in its first year and is now estimated to hold around a third-place position in the local market. European expansion followed. Hugel received a positive opinion from the European Medicines Agency in 2022. Since then, it has obtained approvals in over 30 countries, including major European markets such as Germany, the UK, France, Italy, and Spain.

The US market is central to Botulax's global strategy. Hugel spent years on clinical trials and regulatory procedures for US entry. In February 2024, the US Food and Drug Administration (FDA) approved Letibo 50-unit and 100-unit products for glabellar lines. The first shipment to the US was sent in July 2024, and local sales began in 2025. Industry analysts view the FDA approval as a key milestone for Botulax. The US has a large aesthetic and cosmetic market, including botulinum toxin. The FDA approval also signifies that the product's quality management and clinical data meet US standards, serving as a benchmark for further global expansion. **Direct Sales in the US Planned Amid Growth** Botulax's global expansion is reflected in Hugel's financial results. According to public filings, Hugel's consolidated revenue for the first quarter of 2026 reached KRW 116.6 billion, up 29.9% year-on-year. Operating profit was KRW 47.6 billion, a 22.3% increase. Overseas business drove growth. Hugel's first-quarter overseas revenue rose 48% year-on-year, accounting for 63% of total revenue. Notably, North and South American revenue surged to KRW 15.7 billion, up 317.2% year-on-year, reflecting the initial impact of Botulax's US sales. Botulax sales have steadily increased: from KRW 109.5 billion in 2020 to KRW 124.6 billion in 2021, KRW 160.8 billion in 2022, KRW 168.5 billion in 2023, KRW 201.6 billion in 2024, and KRW 230.5 billion in 2025—more than doubling in five years. In the US, Hugel sells Letibo through local partner Beneve. The partnership leverages Beneve's sales network for product distribution, medical professional training programs, and academic activities. This strategy aims to expand local touchpoints, given the importance of treatment experience and medical professional networks in the US market. Looking ahead, Hugel plans to add direct sales. The company is pursuing a structure that combines Beneve's distribution with its own sales organization. It intends to accelerate US market penetration by increasing investment in local personnel and distribution networks through its US subsidiary, Hugel America. Hugel has set a target to expand its botulinum toxin market presence to 80 countries by 2028. The key question is whether Botulax, which started in the domestic market, can grow into a global toxin product after entering the US, Europe, and China. A Hugel representative stated: "The increase in North and South American revenue is seen as the result of Letibo's US market entry effects being fully reflected. Currently, sales in the US are based on the partnership with Beneve, but from the second half of the year, we plan to implement a structure that combines direct sales through Hugel America to enhance execution in the US market and drive revenue growth."

Source: Read the original report | Published: May 27, 2026