In a strategic pivot, Medytox has altered its primary botulinum toxin (BTX) product to enter the Chinese market.

According to the company, it recently decided to withdraw its drug registration application for Meditoxin (export name: Neuronox) with China's National Medical Products Administration (NMPA) that was originally filed in 2018.

Instead, it has resolved to spearhead its China expansion with Newlux, a next-generation BTX product in a freeze-dried powder formulation developed by its subsidiary, Numeco.

The BTX is characterized by enhanced safety by excluding animal-derived ingredients in the production process, minimizing denaturation of the active neurotoxin protein through a non-chemical treatment process, and improving production yield and quality (purity) by applying the latest manufacturing process.

The decision was based on the judgment that given the future growth of the Chinese market, entering the country with the Newlux, which is fully equipped with a mass production system and the latest manufacturing process, has a strategic advantage over Meditoxin.

Medytox has begun mass production of its next-generation toxin product, Newlux, which obtained domestic approval in September, at its Osong 3 plant, which has a much larger production scale than its Ochang 1 plant.

The company concluded that the difference in plant size would also help the company supply Newlux more smoothly.

"Newlux's entry into China is a strategic decision for Medytox to tap into the global toxin market successfully," a Medytox official said. "It is a proactive step to build a more stable global supply chain to respond to the market."

The company is in discussions with several Chinese pharmaceutical companies to bring Newlux to the Chinese market as soon as possible, and it will accelerate its negotiations to achieve tangible results, he added.