ATGC Receives Domestic Approval for 'Pure-Type Botulinum Toxin'

'Botaruma Ju,' Same Formulation as 'Xeomin,' Receives Third Domestic Approval
Second in the World to Obtain Both Pure-Type and Complex-Type Approvals

ATGC Co., Ltd. announced on June 10 that its pure-type botulinum toxin product, 'Botaruma Ju,' has received domestic product approval from the Ministry of Food and Drug Safety.

ATGC's complex-type botulinum toxin 'Toxon Ju' (left) and pure-type botulinum toxin 'Botaruma Ju'. ATGC

Botaruma Ju is a pure-type toxin formulation that contains only a single 150kDa (kilodalton) neurotoxin, the same as 'Xeomin' from Merz in Germany. It is gaining attention as a next-generation, high-purity botulinum toxin. By using a purification technology that removes non-toxic proteins, the product minimizes immunogenicity and maintains efficacy and safety even with repeated administration.

This product approval marks the third pure-type botulinum toxin formulation to be approved in Korea and the fourth worldwide. Following the commercialization of its complex-type toxin 'Toxon Ju' in February this year, ATGC has now succeeded in commercializing its second botulinum toxin product. As a result, ATGC has become the second company in the world to obtain product approvals for both pure-type and complex-type botulinum toxin products.

In addition, ATGC has signed exclusive global licensing agreements with major partners such as Menarini Group in Italy and Sinclair in the United Kingdom, establishing a foundation for rapid market entry through these large partners. The company is simultaneously pursuing clinical trials and regulatory approvals in major countries, including Europe and the United States. ATGC is also leveraging its global-level CMO (contract manufacturing organization) network and manufacturing technology to secure a competitive edge in quality.

Jang Sungsoo, CEO of ATGC, stated, "The domestic product approval of Botaruma Ju is a meaningful achievement that validates ATGC's high-purity toxin technology." He added, "With our dual toxin portfolio, including Toxon Ju, we will actively target the global aesthetics and therapeutic markets." He further said, "As our ongoing efforts to expand global licensing agreements and enter clinical trials in Europe and the United States are becoming more concrete, this approval will serve as a positive turning point for enhancing the company's global competitiveness, advancing our plans for listing, and building market trust."