More than a year after a refused filing, CEO Jung Hyun-ho is preparing a renewed push into the U.S. market.
The company is dividing its global strategy between liquid toxin for the United States and freeze-dried products for emerging markets.
Jung Hyun-ho, CEO of Medytox
[Insight Korea = An Hye-wan]
Medytox CEO Jung Hyun-ho is making another attempt to secure U.S. Food and Drug Administration approval for the company’s liquid botulinum toxin product, MT10109L. The renewed push comes more than a year after Medytox first submitted a biologics license application, or BLA, in December 2023, only to receive a refusal-to-file letter in February 2024 because of insufficient documentation.
The U.S. market remains one of the biggest unresolved challenges for Jung. He founded Medytox in 2000 and entered the botulinum toxin market in 2006 with the launch of Meditoxin, South Korea’s first and the world’s fourth botulinum toxin product. As the country’s first doctorate holder in the botulinum toxin field, Jung has spent the past 26 years building the company’s presence in South Korea and emerging markets.
If Medytox succeeds in entering the United States, the market will see three Korean botulinum toxin companies competing on U.S. soil: Hugel with Letybo, Daewoong Pharmaceutical with Jeuveau and Medytox with MT10109L.
Its Own BLA After Eight Years
Jung’s attempt to enter the U.S. market dates back to 2013, when Medytox signed a licensing deal with Allergan, now part of AbbVie. Allergan completed Phase 3 clinical trials but abruptly returned the rights in September 2021.
Medytox then moved to pursue U.S. approval on its own for the same liquid toxin under the internal code name MT10109L. On Dec. 27, 2023, it submitted a BLA to the FDA. The agency declined to accept the filing, citing the absence of a specific validation test report.
Medytox immediately began working to address the deficiencies. The company had aimed to resubmit the application last year, but the process appears to have been delayed as additional verification steps, including the reselection of a clinical research organization, took longer than expected. The supplementary materials are now said to be nearing completion.
If Medytox enters the U.S. market, it will compete with Daewoong Pharmaceutical and Hugel. Daewoong was the first Korean company to enter the U.S. toxin market. In May 2019, it launched Jeuveau, the U.S. name for Nabota, through its partner Evolus. Now in its seventh year in the market, Jeuveau holds about a 14 percent share of the U.S. aesthetic toxin market, ranking second. Its U.S. sales in 2024 were about 365 billion won.
Hugel, now in its second year in the U.S. market, received FDA approval for Letybo in February 2024 and launched the product last year in partnership with Benev. In October, the company recruited former AbbVie executive Carrie Strom as global CEO, accelerating its U.S. expansion.
Starting this year, Hugel is using a hybrid model that combines direct sales and partnerships. Its current U.S. market share is about 3 percent, with a goal of reaching 10 percent by 2028.
Medytox, which is returning to the challenge, is seeking to differentiate itself through formulation. MT10109L is a liquid type A botulinum toxin, unlike other Korean toxin products exported abroad. Among the seven botulinum toxin products currently sold in the United States — AbbVie’s Botox, Ipsen’s Dysport, Merz’s Xeomin, Supernus’s Myobloc, Daewoong’s Jeuveau, Revance’s Daxxify and Hugel’s Letybo — there is no type A liquid formulation positioned as a main product in the aesthetic market.
Medytox also plans to enter the United States through direct sales. A company official said, “The product being filed in the United States is a liquid toxin, and because we have a local subsidiary, we are considering direct sales.”
Medytox’s U.S. subsidiary, Luvantas, was established in Irvine, California, in January 2024. It is led by Thomas Albright, a toxin specialist formerly with Allergan.
Freeze-Dried Products for Emerging Markets, Liquid Toxin for the United States
Separately from its U.S. push, Medytox is expanding globally with a lineup of freeze-dried formulations. At the center of that strategy is Newlux, a product developed by affiliate Newmeco that received approval from Korea’s Ministry of Food and Drug Safety in September 2023.
According to investor relations materials posted by Medytox this month, Newlux added registration in Ukraine in the first quarter and has now been approved in eight countries. Its main markets include Latin American countries such as Peru, Bolivia, the Dominican Republic and El Salvador, as well as Thailand, Georgia, Moldova and Ukraine. Neuronox, the same brand operated by Newmeco, has completed registration in 24 countries.
Overseas toxin sales in the first quarter reached 21.4 billion won, up 53 percent from the previous quarter and 35 percent from a year earlier. The company has also resumed shipments to Brazil, the largest market in Latin America.
In China, Medytox is conducting Phase 3 clinical trials for Newlux, while two hyaluronic acid filler products under the Neuramis brand have entered the registration process. In Europe, two Neuramis products have received CE certification under the Medical Device Regulation, or MDR, and the company is preparing to expand its distribution network.
The company said on the 14th that it may enter Europe and the United States with other products, but no confirmed plans have been set.
Through MDT International, its Japanese subsidiary established in 2015, Medytox has supplied the liquid toxin Innotox to the Japanese market. However, it has not yet received formal product approval from Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA. The company plans to pursue formal approval with MT10109L. In January 2024, it signed a contract with a global clinical research organization and began preparatory work for a clinical trial application. Its target is approval in 2028.
Medytox’s global strategy is built around a dual structure of products, regions and production sites. MT10109L, the liquid toxin produced at the Osong Plant 2, where the company is pursuing FDA cGMP certification, is aimed at the U.S. market. Newlux, the freeze-dried product produced at Osong Plant 3, is intended for emerging markets in Latin America, the Middle East, Asia and Eastern Europe.
Plant 3 is also scheduled for capacity expansion. The company explained that “Plant 3 has the nature of an additional domestic manufacturing site, and in the long term, it is intended to expand capacity by transferring volume from Plant 1.”
A Medytox official said, “Based on the competitiveness of our core botulinum toxin business, we are continuing management strategies to improve profitability.”
“We will continue strengthening our growth foundation by expanding next-generation products in global markets and carrying out major projects without disruption,” the official added.
- This article was translated by ChatGPT. (이 기사는 챗GPT가 번역했습니다.)
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