Huons Biopharma to Take Legal Action Over Revoke of Liztox Injection Approval

Huons Biopharma has announced legal action after the Ministry of Food and Drug Safety (MFDS) revoked the product approval for the botulinum toxin (BTX) formulation 'Liztox Injection 100 Units.'

Huons Biopharma Riztox Injection 100 Units. [Image provided by Huons Biopharma]

On the 4th, Huons Biopharma stated on its website, "Indirect export is a trade method recognized under the Foreign Trade Management Regulations," affirming this position.

Earlier, the MFDS announced that it had canceled the product approval for 'Liztox Injection 100 Units,' which was sold domestically without obtaining national batch release approval, and imposed a six-month suspension on all manufacturing operations. At the same time, the MFDS ordered Huons Biopharma to recall and dispose of the distributed pharmaceuticals and urged medical institutions storing the products to actively cooperate with the recall.

The company explained the background of this decision, stating, "The MFDS maintains the position that when botulinum toxin products are indirectly exported through domestic trading companies, it is considered domestic sales rather than exports, and thus all regulations stipulated by the Pharmaceutical Affairs Act, including national batch release approval, must be complied with." They added, "Accordingly, the penalty was imposed on our company for exporting botulinum toxin products via indirect export methods."

Huons Biopharma has been exporting BTX formulations in the form of indirect exports. First, the BTX formulations are supplied to domestic trading companies or wholesalers, who then export them overseas. In this process, the BTX formulations were handed over to the trading companies without obtaining national batch release approval, but the MFDS judged this as domestic sales. Since export-only pharmaceuticals were sold domestically, it was deemed a violation of the Pharmaceutical Affairs Act.

In response, Huons Biopharma stated, "Even if pharmaceuticals are exported through domestic trading companies, we have maintained the position that these pharmaceuticals are considered export-only and thus the Pharmaceutical Affairs Act does not apply." They also argued, "The Korea International Trade Association under the Ministry of Trade, Industry and Energy has recognized the results of indirect exports as export performance and has awarded us export trophies, indicating that indirect exports of pharmaceuticals have been recognized as exports for a considerable period from the past to the present."

The company added, "On the premise that the penalty imposed by the MFDS on our BTX indirect export activities is illegal and unjust, we plan to actively take all necessary legal actions, including filing objections." They emphasized, "Liztox is a verified quality product that has never had safety or efficacy issues during the national batch release approval process since its launch."

Prior to Huons Biopharma, Medytox, Hugel, PharmaResearch, Jetema, Korea BMI, and Korea BNC also received product approval cancellations for BTX formulations from the MFDS for the same reason. These companies filed injunctions to suspend enforcement and administrative lawsuits with the Administrative Court against the MFDS's decisions. Subsequently, as the court accepted the injunctions, these products are currently being released normally.

Meanwhile, Huons Biopharma added, "The subject product of this penalty is limited to 'Liztox Injection 100 Units (export product name: Hutox Injection 100 Units),' and 50 Units and 200 Units are not subject to this penalty."

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