Newmeco Receives Product Approval for Next-Generation Botulinum Toxin 'Newlux' in Georgia

Successful Expansion into Three Countries:
After Thailand in Asia and Peru in Latin America, Now Georgia in Europe

Newmeco, a subsidiary of the biopharmaceutical company Meditox, announced on August 13 that it has obtained new product approval for the 100-unit size of 'Newlux' from the Medical and Pharmaceutical Activities Regulatory Agency under the Ministry of Health of Georgia. This marks the company’s third overseas entry following Thailand in Asia and Peru in Latin America, and its first entry into a European country.

Newmeco's 'Newlux' product in 100-unit size. Photo by Meditox

Meditox expects that securing approval in Georgia, a strategic hub connecting Europe and Asia, will serve as a launching point for 'Newlux' to further expand its global presence in the second half of the year. 'Newlux' is a botulinum toxin formulation developed by Newmeco after receiving a technology transfer of the toxin candidate (MBA-P01) from Meditox. Noting that human serum albumin (HSA), used as an excipient, can cause allergic reactions, Newmeco applied an animal component-free process during raw material production for the first time among 900 kDa (kilodalton) botulinum toxin powder formulations. By reducing chemical processing steps, the company also minimized toxin protein denaturation, making 'Newlux' a next-generation botulinum toxin product.

A Newmeco representative stated, "With Newlux obtaining product approval in Georgia, located in Europe, while pursuing approvals in over 20 countries worldwide, we anticipate faster regulatory procedures and the formation of local partnerships in neighboring regions." The representative added, "Through successful entry into the global market, we aim to showcase Meditox's unique competitiveness and excellence."

Meanwhile, Meditox has begun production of Newlux at its third plant, which is equipped for mass production, and has been actively seeking regulatory approvals for overseas expansion since last year. So far, the company has obtained product approvals in Peru, Thailand, and Georgia, with registrations pending in more than 20 additional countries, raising expectations for explosive sales growth in the future.