Medytox Korea Applies for Approval of Next-Generation Botulinum Toxin 'Newlux'

[Asia Economy Reporter Lee Chun-hee] Medytox's affiliate Medytox Korea announced on the 31st that it has applied for product approval from the Ministry of Food and Drug Safety for a new toxin formulation 'Newlux (MBA-P01)' indicated for the improvement of glabellar lines.

Newlux is the official product name of MBA-P01, developed as a next-generation botulinum toxin formulation, combining "new" and "lux" (meaning light intensity) to signify "new light." Newlux features an improved latest manufacturing process that reduces the possibility of contamination from impurities. It uses only non-animal-based media during strain cultivation and completely excludes chemical treatment processes, minimizing the denaturation of toxin proteins and enhancing product stability.

Newlux completed Phase 2 clinical trials in Australia in September 2020 and subsequently demonstrated efficacy and safety through Phase 3 clinical trials in April of this year.

Joo Hee-seok, CEO of Medytox Korea, said, "With this approval application, the launch of the next-generation toxin formulation Newlux has entered its final stage," adding, "We will focus all our capabilities on the successful market entry of Newlux and grow it into a game changer dominating the global toxin market." He further stated, "We will also promptly proceed with clinical trials to obtain approvals in overseas countries and secure additional indications."