Hugel Completes Application for Toxin Sales Approval in Europe... "Preparing to Enter the 1 Trillion Won European Market"

[Asia Economy Reporter Hyunseok Yoo] Hugel has entered the final stage of entering the European botulinum toxin market worth about 1 trillion KRW.

Global total medical aesthetic specialist company Hugel announced on the 30th that it has completed the application for sales approval of its botulinum toxin formulation in Europe.

Earlier, in January last year, Hugel completed Phase 3 clinical trials (Bless1, 2) in Poland and Germany together with its European distribution partner, Croma. Afterwards, it proceeded with the documentation required for the approval application and submitted the application to the European Medicines Agency (EMA) on the 29th (local time). Since it takes about one year from submission to approval, it is expected that sales approval in Europe will be obtained around mid-next year.

The European botulinum toxin market is worth about 1 trillion KRW and, along with the United States, accounts for more than 70% of the global botulinum toxin market. After obtaining sales approval, Hugel aims for a successful foothold in the European market by partnering with the Austria-based pharmaceutical company Croma, which will handle the distribution of ‘Letybo’ (European export name) in the European market.

Croma is a medical aesthetic specialist company producing dermal fillers, skincare products, lifting threads, PRP devices, and more. It has a rich database of aesthetic treatment specialists in the local market, as well as over 40 years of accumulated marketing know-how and successful experience, raising expectations for efficient and systematic marketing tailored to the local market. In particular, through synergy effects with Croma’s flagship product ‘Saypha filler,’ it aims to rapidly expand market share and achieve a 10-15% market share in Europe by 2025.

A Hugel official said, “Europe is one of the major markets leading the global botulinum toxin market along with China and the United States, and the submission of this sales approval application will be a cornerstone for Hugel’s full-scale global market expansion.” He added, “Along with this, we plan to focus on becoming a global company by successfully entering the global big three markets: China, where approval is expected around mid-year, and the United States, where we aim to submit the sales approval application by the end of this year.”

This content was produced with the assistance of AI translation services.