Medytox said it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for MT10109L, a non-animal-derived liquid botulinum toxin (BTX) formulation indicated for improving moderate to severe frown lines and crow's feet.

The submission follows Medytox's completion of five large-scale global phase 3 clinical trials of MT10109L in February, involving 1,300 patients in the U.S., Canada, and European medical institutions.

The trials demonstrated significant improvement in frown lines and crow's feet compared to placebo, and long-term safety was also established through repeated administration.

According to Medytox, the submission makes it the world's first to successfully apply for product approval for such a liquid toxin formulation, as there are no liquid toxin formulations in the U.S.

The self-developed MT10109L eliminates animal-derived ingredients throughout the entire manufacturing process, including strain cultivation and raw material production, and does not use Human Serum Albumin (HSA) as an adjuvant, thereby fundamentally preventing the possibility of animal-derived virus infection.

Also, the manufacturing process minimizes the number of chemical processing steps, reducing the potential for denaturation of the active neurotoxin protein.

Medytox is preparing to manufacture MT10109L in bulk as it has been preparing for the FDA's inspection of its Osong Plant 2, which has been pursuing current good manufacturing certification (cGMP) since earlier this year.

The company said it is fully committed to establishing the optimal promotion strategy, including distribution network operations, marketing, and advertising, to maximize market share in the U.S. with a target launch in 2025.

"Medytox, which has developed the first toxin formulation in Korea and accumulated decades of R&D capability and know-how, has taken the first step towards becoming a global biopharmaceutical company with the U.S. application of MT10109L," Medytox CEO Jung Hyun-ho said. "We have focused on preparations and internal capacity building for a long time for our entry into the U.S. market, and we will show the successful entry of MT10109L into the U.S. market."