November 17, 2025 – SEOUL, South Korea — PROTOX Inc. announced that it has officially obtained marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its botulinum toxin product, Protoxin Injection. This marks a major regulatory milestone for the company following the completion of all required clinical and quality reviews.

Protoxin was originally developed through PROTOX’s own proprietary technology, including its patented vacuum-drying manufacturing process designed to enhance product stability and purity. After submitting its New Drug Application in December 2023, the company successfully completed both the MFDS-requested Phase 3 extension study and additional comparative assessments, demonstrating consistent efficacy and safety levels comparable to global competitors.

With this approval, PROTOX becomes one of the few Korean companies to secure domestic authorization for a next-generation botulinum toxin product based on fully independent R&D and GMP manufacturing capabilities. The company stated that it will now accelerate its global expansion strategy, including regulatory submissions in major overseas markets such as the EU, Turkey, Thailand, and China.

A PROTOX representative commented,
“This approval is a key achievement for our team and a validation of our long-term development efforts. With the Korean authorization now in place, we will move rapidly toward international filings and commercial launch plans with our global partners.”

PROTOX plans to strengthen its international footprint through strategic partnerships, leveraging the approval to expedite global commercialization of Protoxin.