ATGC wins MFDS nod for BTX Injection

ATGC, a Korean biopharmaceutical company, said Tuesday that Botaluma Injection, its new botulinum toxin (BTX) product, received marketing approval from the Ministry of Food and Drug Safety (MFDS).

Botaluma Injection is a pure-form botulinum toxin type A that contains only the 150 kDa core neurotoxin protein, excluding complexing non-toxic proteins.

According to this company, this formulation is similar to Xeomin, developed by Germany’s Merz. It is designed to minimize immunogenicity by eliminating accessory proteins that can lead to antibody formation.

The approval marks the third pure-form botulinum toxin authorized in Korea and the fourth globally. It also represents ATGC’s second botulinum toxin product to receive approval, following the complex-type Toxon Injection, which was cleared by Korean authorities in February.

With both products now commercially approved, ATGC becomes the second company in the world to obtain regulatory clearance for both pure-type and complex-type botulinum toxins.

“The approval reflects the strength of our high-purity neurotoxin platform,” ATGC CEO Jang Sung-su said. “Together with Toxon Injection, our two-product portfolio positions us to actively pursue opportunities in both the aesthetic and therapeutic sectors of the global market.”