ATGC has applied for the domestic approval of its new BTX product ATGC-110, or “Pure-Type Botaluma Injection (clostridium botulinum toxin type A, 150kDa),” for an indication that temporarily improves moderate to severe glabellar wrinkles.
ATGC expects Botaluma to be Korea's third pure-type botulinum toxin, following Merz's Xeomin and Medytox's Coretox.
Botaluma is a pure-type product that removes non-toxin proteins that cause antibody formation (tolerance) and is relatively safe to use even for repeated and high-dose procedures.
While complex-type botulinum toxin products have been competing mainly on price, the market's center of gravity has recently shifted to products with less tolerance rather than price competitiveness, an ATGC official said. Therefore, the official added that it is a next-generation botulinum toxin product that is expected to grow.
Last October, ATGC signed a strategic collaboration and global exclusive license agreement with China's Huadong Medicine and its subsidiary Sinclair to commercialize Botaluma for all aesthetic and therapeutic indications, excluding Korea.
Sinclair will distribute the product under the global brand name Botaluma Injection in licensee countries worldwide.
ATGC will be responsible for the approval of Botaluma from the Ministry of Food and Drug Safety and will co-commercialize the product with Sinclair in Korea. It expects to win approval after the middle of this year.
Company officials said that Young Tox Injection (ATGC-100), a complex botulinum toxin formulation, is under review for marketing authorization. ATGC’s recent GMP due diligence for overseas manufacturing sites was also completed without any major deficiencies and is expected to get approval in the first half of the year, they added.
ATGC, speeding up the commercialization of two botulinum toxin products, said clinical preparations for overseas licenses are progressing smoothly through smooth cooperation with overseas partners.
"This year will be the first year of product sales, and we are accelerating to lay the foundation for the company to make a quantum jump," CEO Jang Sung-su said.
As ATGC completes the global value chain from production to sales, market watchers said the company’s new business model draws the industry’s attention.