Medytox, led by Hyun-Ho Jung, announced on December 27th its submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for 'MT10109L (NivobotulinumtoxinA).' The liquid botulinum toxin targets moderate to severe glabellar and crow's feet lines, signifying the company's U.S. market re-entry after a decade-long partnership with AbbVie (formerly Allergan). Notably, 'MT10109L' stands as the only liquid botulinum toxin among existing U.S. products.

Distinguished by its non-animal derived nature, 'MT10109L' avoids animal components in its production, including cultivation and raw material sourcing. Medytox sidesteps potential animal-based virus contamination by eschewing Human Serum Albumin (HSA) as a stabilizer and diminishes denaturation risks of the neurotoxin protein through minimal chemical treatment in raw material processing.

Preparation for FDA inspection of Osong Plant 2, geared for cGMP certification, has been underway since earlier this year by Medytox. Beyond this, the company is strategically aligning distribution, marketing, and advertising for an optimal market share grab upon the anticipated 2025 launch in the United States.

Hyun-Ho Jung, CEO of Medytox, remarked, "Our submission of MT10109L to the U.S. signifies a significant global stride for Medytox, built on decades of R&D and the pioneering of Korea's first botulinum toxin product." He emphasized the company's readiness and determination for a successful introduction of 'MT10109L' into the largest market, stating, "Our advanced next-generation liquid botulinum toxin product is poised for a successful U.S. market entry."