Medytox to Enter Chinese Market with 'Newlux' Instead of Meditoxin

NewLux, Next-Generation Freeze-Dried Toxin Formulation
Withdrawal of Meditoxin Imported Drug Registration Application

Medytox aims to enter the Chinese market with its next-generation botulinum toxin (BTX) product, NewLux.

Next-generation toxin formulation 'NEWLUX' by Newmeco, a subsidiary of Medytox.
[Photo by Medytox]

On the 24th, Medytox announced that it has withdrawn the import drug registration application for Medytoxin (export name: Neuronox), which was submitted to the China National Medical Products Administration (NMPA) in 2018, and will actively pursue entry into China with NewLux, the next-generation toxin product developed by its affiliate NewMeco.

This decision reflects the anticipated growth potential of the Chinese market. Medytox explained that entering China with NewLux, a next-generation product equipped with a mass production system and the latest manufacturing processes, is considered a better option than the previous plan.

Supply issues also played a role in the decision to promote NewLux’s entry into the Chinese market. Medytoxin, which is already supplied to several overseas countries, is produced only at the Ochang Plant 1, raising concerns that supply could be disrupted even if Chinese approval is obtained in the future. Unlike Medytoxin, NewLux is produced separately at the Osong Plant 3.

Medytox has started mass production of NewLux, which has obtained domestic approval, at Osong Plant 3, where production capacity is several times larger than Ochang Plant 1. At the same time, discussions with multiple overseas pharmaceutical companies have begun to expedite entry into China.

A Medytox official stated, "The decision to enter China with NewLux is a strategic move for Medytox to successfully target the global toxin market," adding, "It is a proactive measure to establish a more stable global supply chain in response to the market."

The official continued, "We are in discussions with multiple pharmaceutical companies to ensure that NewLux, the next-generation toxin product developed by NewMeco using the latest manufacturing processes, can enter the Chinese market as soon as possible, and we will accelerate negotiations to achieve tangible results."

NewLux is a next-generation freeze-dried toxin product that received product approval from the Ministry of Food and Drug Safety on August 31. NewLux enhances safety by excluding animal-derived ingredients during the raw material production process and minimizes denaturation of the active neurotoxin protein through non-chemical processing. The application of the latest manufacturing processes has also improved production yield and quality (purity).

This content was produced with the assistance of AI translation services.