DSK Subsidiary ProTox Secures Domestic Approval for Botox... Accelerates Global Expansion

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ProTox, a subsidiary of the KOSDAQ-listed company DSK, announced on the 17th that its independently developed botulinum toxin (botox) formulation has received official product approval from the Ministry of Food and Drug Safety (MFDS).

With this approval, ProTox has been officially recognized as a specialized K-bio botulinum toxin company capable of independently handling the entire process from research and development to quality control and production, securing a foundation for expanding into both domestic and international markets.

After applying for product approval in December 2023, ProTox completed phase 3 clinical trials as required by the MFDS review and additionally finished an extension study. Through this, the company scientifically demonstrated not only non-inferiority compared to global competitors, but also the sustained efficacy and safety of repeated administration and switching from other products.

The newly approved ProTox botulinum toxin formulation has secured technological advantages such as: ▲high purity active ingredient production technology ▲high quality reproducibility through a patented in-house purification and manufacturing process ▲a complete GMP-based aseptic manufacturing, quality control (QC), and data integrity system ▲100% in-house cultivation and production based on the government-registered ATCC 3502 strain.

ProTox products are manufactured at a GMP-certified facility in the Hyangnam Pharmaceutical Complex, which is equipped with the technology and infrastructure to independently handle every stage from strain acquisition, cultivation, purification, formulation, filling, to packaging. This facility is evaluated as having global-level production and quality competitiveness, based on an internationally compliant quality system and large-scale automated production lines.

Leveraging this differentiated technological competitiveness, ProTox has been continuously expanding its global distribution network by signing long-term supply agreements (LTAs) with major markets such as Russia, the Commonwealth of Independent States (CIS), Brazil, China, and Turkiye. The company is also actively negotiating with leading local partners for further market entry into key regions including Europe, the United States, Central and South America, the Middle East, and Southeast Asia.

The botulinum toxin market is rapidly expanding, with an average annual growth rate of 9.8%. In particular, demand is spreading from the traditional US and European centers to Asia, the Middle East, and Central and South America, and the expansion of indications for therapeutic purposes, in addition to cosmetic use, is serving as a key driver of market growth.

Kim Changsoo, CEO of ProTox, stated, "This domestic product approval is the result of the MFDS officially recognizing ProTox's independently accumulated research and development (R&D) capabilities and GMP production technology over many years," adding, "With this approval, not only will we be able to supply our products to the domestic medical field, but we will also accelerate our entry into the world’s largest botulinum toxin markets, including the United States and Europe."

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