Approval imminent for Korea's 3rd pure botulinum toxin product

The government will likely approve the nation’s third pure botulinum toxin product after Merz's Xeomin and Medytox's Coretox, pharmaceutical market sources said Thursday.

ATGC's pure botulinum toxin, ATGC-110, may soon receive approval as the Ministry of Food and Drug Safety has completed drug efficacy verification of the product.

Pure botulinum toxin has removed unnecessary complexing proteins through a new purification technology.

According to industry insiders, the Ministry of Food and Drug Safety (MFDS) has completed the drug efficacy verification of ATGC's ATGC-110, a pure botulinum toxin, which the company had applied for approval. The ministry has completed the safety and efficacy review of the product, and industry insiders expect that ATGC will soon receive product approval.

In the case of a new drug, the ministry decides on final product approval by conducting a good manufacturing practice (GMP) review that checks safety and efficacy, product quality, and compliance with manufacturing process standards through analysis of result data such as clinical trials.

The approval follows ATGC's randomized, double-blind, active group control, single-center phase 1 and 2 trial for ATGC-110 in adult patients needing moderate or severe forehead wrinkle improvement in 2019.

The company has conducted a phase 3 clinical trial to compare the efficacy and safety of ATGC-100 with Allergan's Botox since 2020.

ATGC-110 is a product that purifies only 150kDa pure toxin protein by removing non-toxic protein.

The company has reduced the possibility of developing resistance through the process while maintaining the medicinal effect.