Medytox's subsidiary Numeco announced that it has obtained a new product license for 100 units of “Newlux” from the Regulation Agency for Medical and Pharmaceutical Activities under Georgia’s Department of Health. This marks the company's third overseas expansion following Thailand in Asia and Peru in Latin America, as well as its first entry into Europe.

Medytox expects that the approval in Georgia, a strategic hub connecting Europe and Asia, will serve as a catalyst for Newlux's global expansion in the second half of the year.

Newlux is a botulinum toxin product developed by Numeco after receiving technology transfer of the toxin candidate material (MBA-P01) from Medytox.

It is the first botulinum toxin formulation in powder form with a molecular weight of 900 kDa (kilodaltons), which excludes animal-derived components during the raw material production process, inspired by the potential for allergic reactions caused by human serum albumin (HSA) used as an excipient. It also minimizes toxin protein denaturation by reducing the number of chemical processing steps, making it a next-generation botulinum toxin formulation.

“With Newlux securing product approval in Georgia in Europe, while pursuing approvals in over 20 countries worldwide, we expect to gain momentum in expediting approval procedures in neighboring regions and establishing local partnerships,” a Numeco official said. “We aim to demonstrate Medytox’s unique competitive edge and excellence through successful market penetration globally.”

Medytox has commenced production of Newlux at its Medytox 3 plant, which is equipped with a large-scale production system, and has been actively pursuing regulatory approvals for overseas expansion since last year. To date, the product has received marketing authorization in three countries and is pending approval in over 20 additional countries.