Hugel said Tuesday that it has won the first round of lawsuit against the head of the Seoul Food and Drug Safety Office to rescind the latter’s administrative order to revoke the license of its botulinum toxin product, Botulax, and stop its manufacturing and sales.

On Feb. 8, the Seoul Administrative Court issued a ruling canceling the Ministry of Food and Drug Safety (MGDS)'s decision to revoke Botulinum toxin product license and order to recall and destroy all manufacturing numbers. Hugel explained that it received the judgment from the court on Tuesday.

The ruling rescinds the MFDS's Dec. 2, 2021, decision to revoke the product license and order to recall and destroy Botulax. The court also ruled that Hugel bear two-fifths of the litigation costs and MFDS, the rest.

However, the court rejected Hugel's request to rescind the provisional cease and desist order and the suspension of sales business order issued by the MFDS on Nov. 10 and Dec. 2, 2021.

Hugel said that the provisional cease and desist order dated Nov. 10, 2021, and the order to recall and destroy some manufacturing numbers will have no impact on the company's business even if the contents of the first judgment are confirmed.

In addition, in the case of the one-month sales suspension order dated Dec. 2, 2021, enforcement has been suspended until March 9, depending on the court's decision, and the enforcement period may be extended depending on whether an appeal is filed or a stay of enforcement is applied, the company added.

Hugel’s win comes amid a series of manufacturers’ legal victories against the regulator regarding botulinum toxin drug product licenses and orders to stop manufacturing and sales. In July and November last year, Medytox and PharmaResearchBio won the first trial.

Currently, Jetema, BNC Korea, BMI Korea, and Huons BioPharma are facing lawsuits against the MFDS.