Medytox Applies for FDA Approval of Non-Animal Liquid Toxin Formulation 'MT10109L' in the US

Medytox has applied for U.S. approval of its liquid toxin formulation 'MT10109L,' making its entry into the world's largest toxin market, the United States, more tangible.

Global biopharmaceutical company Medytox announced on the 27th that it has submitted an application to the U.S. Food and Drug Administration (FDA) for approval of its non-animal-derived liquid botulinum toxin formulation 'MT10109L,' indicated for the improvement of moderate to severe glabellar lines and crow's feet (lateral canthal lines). With this, Medytox is launching its attack on the world's largest U.S. market through the next-generation liquid toxin formulation 'MT10109L.' To date, no liquid formulations of toxin products have been marketed in the U.S.

Medytox's self-developed non-animal-derived liquid toxin formulation 'MT10109L' excludes the use of animal-derived components throughout the entire manufacturing process, including strain cultivation and bulk production, and does not use human serum albumin (HSA) as an excipient, thereby fundamentally eliminating the possibility of animal-derived viral infections. Additionally, the chemical treatment steps in the bulk manufacturing process have been minimized to reduce the potential denaturation of the active neurotoxin protein.

To prepare for the FDA inspection of Osong Plant 2, which is pursuing cGMP certification for the production of 'MT10109L,' Medytox has been operating an internal preparation system since early this year and has also initiated pre-inspection procedures. The company is making every effort to establish an optimal promotional strategy that combines distribution network operation, marketing, and advertising, aiming for a U.S. launch in 2025.

Jung Hyun-ho, CEO of Medytox, said, "Medytox, which developed the first toxin formulation in Korea and has accumulated decades of R&D capabilities and know-how, has opened the first chapter toward becoming a global biopharmaceutical company with the U.S. approval application for 'MT10109L.' We have focused on long-term preparation for inspections and internal capability improvements to enter the world's largest market, the U.S., and we will definitely show successful entry of the advanced next-generation liquid toxin formulation 'MT10109L' into the U.S. market."

Meanwhile, in February, Medytox completed five large-scale global Phase 3 clinical trials of 'MT10109L' involving a total of 1,300 patients at medical institutions in the U.S., Canada, and Europe. The trials demonstrated significant improvements in glabellar lines and crow's feet compared to placebo and secured long-term safety through repeated administration.