South Korea’s top botulinum toxin manufacturer, Hugel Inc., is set to resume exports of its flagship product, Botulax, to China and plans to expand its product lineup to include HA fillers, further strengthening its market presence in the world’s second largest botulinum toxin market after the U.S.

According to sources on Tuesday, Hugel is scheduled to gradually resume shipments of Botulax to China starting next month. The move aims to maintain appropriate inventory levels in response to the recovery of local demand, which has been hindered by Covid-19 lockdowns.

The company has not made a single shipment of Botulax to China this year.

“As local demand has recently shown signs of recovery, the depletion of Botulax inventory is accelerating. The upcoming launch of HA filler, The Chaeum, in China is also expected to contribute to market share expansion through synergy with Botulax,” said a company spokesperson.

The Chinese botulinum toxin market is experiencing rapid growth, with an average annual growth rate of 30 percent. As Hugel heavily relies on Botulax, which accounts for nearly half of its total sales, the Chinese market is an essential one that cannot be overlooked.

In October 2020, Hugel became the first Korean botulinum toxin manufacturer to obtain marketing approval in China. With an ambitious goal of achieving a market share of over 30 percent within three years of entry, the company had demonstrated a strong commitment to market expansion. However, the Omicron spread in China and the subsequent lockdowns left the company with an overabundance of inventory.

As Hugel recently encountered obstacles in its entry into the U.S., the Chinese market has become even more crucial. Last month, Hugel received a second Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its marketing application for Botulax. Unlike the first CRL, which requested some data supplementation, the recent CRL primarily focused on factory management. Although it is expected that there will be no significant delays in obtaining authorization, the company’s North American market expansion plans have been pushed back from this year to 2025.

Another variable in Hugel’s path to global market expansion is its ongoing legal dispute with Medytox Inc. Medytox filed a lawsuit against Hugel with the U.S. International Trade Commission (ITC), alleging unauthorized use of its bacterial strain.

By Kim Jee-hee and Minu Kim

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