Toxin Trio Launches Full-Scale Attack on World's Largest Market, the US

Hugel Undergoes FDA Inspection at Chuncheon-si Geodugong Factory
Daewoong Pharmaceutical Achieves Solid Results with ‘Jubo’ Since 2019
Medytox Applies for FDA Approval of Liquid Form Last Month

Domestic botulinum toxin developers are rushing to target the United States, the 'world's largest market.' While Daewoong Pharmaceutical, which entered the market first, continues its growth, Hugel and Medytox are also accelerating preparations through approval from the U.S. Food and Drug Administration (FDA).

Hugel's botulinum toxin 'Letibo' (domestic name Botulex) [Photo by Hugel]

According to the pharmaceutical industry on the 31st, Hugel has been undergoing an FDA inspection of its factory in Geodoo, Chuncheon-si, Gangwon Province since the 25th. This is a production facility inspection for the approval of 'Retivo' (domestic name Botulex), for which marketing authorization was submitted to the FDA last September.

This is the third attempt. The first attempt was in March 2021. However, in March of the following year, the FDA requested additional information. The issues were related to the equipment added to the factory and the literature and data concerning the approval requirements after Hugel applied for the license. Hugel supplemented these and reapplied for approval in October of the same year, but in April last year, they received another request for supplementation related to factory management. After addressing this again, they reapplied for approval in October last year. It is expected that the approval decision will be made within the first quarter of this year following this inspection.

Hugel is attempting a third try to enter the U.S. because it is the world's largest market. The global toxin market is estimated to be worth $7.2 billion (approximately 9.6 trillion KRW). North America, including the U.S., accounts for more than half of this market. Although Hugel is already actively selling in Europe and China, which are considered the three major markets along with the U.S., it must focus all efforts on entering the U.S. for greater growth.

Daewoong Pharmaceutical's botulinum toxin 'Jubo' (domestic name Nabota) [Photo by Daewoong Pharmaceutical]

Among domestic toxin developers, Daewoong Pharmaceutical is the most advanced. 'Jubo' (domestic name Nabota), which was the first Asian product to receive FDA approval in 2019, has already achieved considerable success. Through its partner Evolus, sales have rapidly increased, raising its market share to 11%. More than half of Jubo's global sales of 93.5 billion KRW up to the third quarter of last year, amounting to 44.5 billion KRW, came from the U.S. market.

Daewoong Pharmaceutical is also continuing efforts to improve quality and increase production capacity. Botulinum toxin requires reinjection every 3 to 4 months to maintain cosmetic effects. However, last year, Revens Therapeutics launched 'Daxxify,' which extended the interval to 6 months, and Jubo also confirmed a 6-month long-lasting effect in clinical trials. To enter therapeutic fields beyond cosmetics, Daewoong is researching treatment effects for conditions such as cervical dystonia with another partner, Ion Biopharma. In terms of production capacity, they are building a third plant in Hyangnam-eup, Hwaseong-si, Gyeonggi Province, scheduled for completion this year, capable of producing 13 million vials annually.

Medytox also applied for FDA approval of 'MT10109L' last month. It does not use animal-derived ingredients or albumin extracted from human serum, completely eliminating the risk of animal virus infection. Upon approval, it is expected to become the first liquid-form toxin to enter the U.S. market. Unlike the existing freeze-dried powder form that requires dilution with saline, the liquid form does not require dilution, eliminating infection risks during dilution and allowing medical staff to conveniently administer precise doses. The company expects to receive approval around 2025.

Medytox is also considering increasing profits through direct sales. Although direct sales require building a new sales network and involve significant initial investment costs, they offer the advantage of improving long-term profitability once established. After applying for approval of MT10109L, Medytox announced the establishment of its local subsidiary, Lubantas. Lubantas appointed Thomas Albright, who led Allergan's global launch of 'Botox,' as CEO. Hugel is also contemplating detailed launch strategies, including direct sales through its local subsidiary Hugel America, established in 2018.