Hugel "US product approval expected this year... Cancellation controversy is 'resolved'"

"World's Top 3 Markets" US, China, and Europe Aim to Complete Entry Within the Year

Son Ji-hoon, CEO of Hugel, is speaking at an online press conference held on the morning of the 11th. (Photo by Hugel)

[Asia Economy Reporter Lee Chun-hee] Hugel has expressed its determination to complete its entry into the world’s top three botulinum toxin markets? the United States, China, and Europe?within this year and secure a solid position.

On the morning of the 11th, Hugel announced its major strategies for this year during an online press conference.

According to Hugel, the U.S., China, and Europe account for 80% of the approximately 3 trillion KRW beauty toxin market last year. The market sizes are about 1.6 trillion KRW in the U.S., 800 billion KRW in China, and 500 billion KRW in Europe, respectively.

Given the large scale, the U.S. market is undoubtedly the most focused market for Hugel. In March last year, Hugel submitted an application for product approval of its botulinum toxin product “Retivo” (domestic name Botulex) to the U.S. Food and Drug Administration (FDA). The approval process, including related inspections, is underway. Han Sun-ho, Vice President of Hugel’s Sales and Marketing Division, explained, “We expect to receive product approval around mid-year.” He added, “Although the U.S. is the world’s largest market, the actual consumer experience rate is low due to the high price of botulinum toxin procedures, so we see ample opportunity to expand the market.”

Next, the large Chinese market plans to increase its market share from 10% last year to 15-20% this year. Vice President Han said, “To achieve this, we are building networks through the local beauty and plastic surgery expert network ‘C-GEM’ and steadily conducting academic marketing.” He also mentioned, “There is high demand for square jaw (benign masseter hypertrophy) treatment in China,” and that they are preparing for a Phase 3 clinical trial in China to add this indication.

The European market will see full-scale entry within this year. Son Ji-hoon, CEO of Hugel, stated, “Preparations for the first shipment and launch for Europe are underway within the first quarter of this year.” He added, “After completing entry into 11 countries in the first half of the year, we plan to expand to 13 additional countries within this year and 12 more next year, aiming to complete entry into 36 European countries.”

Construction of a new factory to support this market expansion is also underway. Hugel plans to complete its third botulinum toxin factory under construction by June this year. The company expects to secure production capacity that is more than double the current level for both botulinum toxin and fillers through this facility.

Hugel Botulinum Toxin Product 'Retivo (Domestic Name: Botulex)'

Regarding the recent controversy over sanctions by the Ministry of Food and Drug Safety (MFDS), which has become a major issue in the botulinum toxin industry, CEO Son expressed regret over the MFDS’s interpretation of distribution. He explained, “However, there has been no impact on domestic manufacturing, sales, exports, or approvals, and we believe this has been proven by market performance.”

In December last year, the MFDS canceled Hugel’s product approval, claiming that Hugel sold Botulex domestically without national batch release approval. Hugel strongly argued that the product sold to a domestic trading company for export was an indirect export item and did not require national batch release approval for domestic sales. Subsequently, Hugel quickly took legal action, and both the Seoul Administrative Court and the Seoul High Court have consecutively accepted Hugel’s request for suspension of the execution of the approval cancellation.

Considering this situation, CEO Son said, “I believe the controversy is essentially resolved,” adding as a personal opinion, “If indirect exports are considered domestic sales, many companies would be violating the Pharmaceutical Affairs Act, so this is an issue that must be viewed carefully.”

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