In a notable legal development, Hugel has secured a favorable outcome in its legal battles against the Ministry of Food and Drug Safety (MFDS) regarding the indirect export of Botulax, its botulinum toxin (BTX) products, which led to the revocation of its sales license. 

The Seoul Administrative Court ruled in favor of Hugel in its lawsuit against the MFDS, resulting in the cancellation of the  MFDS' manufacturing and sales suspension order for its Botulax products last Thursday.

The court's ruling stemmed from the MFDS's decision in Dec. 2021 to revoke the permits for Hugel's four Botulax products, citing the company's "indirect export" practice of BTX, which did not undergo a separate approval process required for domestic distribution.

Biopharmaceuticals marketed domestically typically undergo a distinct national lot release approval process to ensure compliance with standards and the absence of adulteration or foreign substances.

Following the MFDS's announcement, Hugel filed an injunction with the court to halt the regulatory authority's actions. The Seoul Administrative Court granted the company's request for the temporary suspension and annulment of the MFDS's order on Nov. 11.

Hugel stated that its BTX products were intended for export purposes, but health authorities misunderstood, believing they were intended for local distribution, which prompted regulatory action.

The most recent ruling came after Medytox and Pharma Research Bio experienced legal victories in their disputes with the MFDS.

Previously, the MFDS had issued directives for the recall and disposal of BTX products manufactured by these companies, citing the absence of a separate national lot release approval process. However, the Seoul Administrative Court ruled in favor of both companies, overturning the MFDS's orders to rescind their permits and recall their products, late last year and early this year. 

The MFDS has expressed its intention to appeal the first-instance court decision against Medytox and Pharma Research Bio. However, the agency has not yet indicated whether it will contest the recent ruling favoring Hugel.

According to market observers, the legal outcomes of Hugel, Pharma Research Bio, and Medytox are seen as significant precedents in the ongoing debates concerning the regulation of BTX products as numerous BTX manufacturers, including Jetema, BNC Korea, BMI Korea, and Huons Biopharma, still face administrative penalties from the ministry for engaging in indirect exports.