Orphan drug 'Thio Spal-P' avoids approval cancellation

Seoul Administrative Court ruled in favor of Dongin Pharm's suit, arguing about 'the cancellation measure of imported product approval is wrongful'

Multiple reversals of suspension of reimbursement…MFDS' measure was nullified after a year-long suit

A rare disease treatment, 'Thio Spal-P Inj (thiotepa),' faced narrow escape from receiving approval cancellation.

 

According to pharmaceutical industry sources on the 11th, the Seoul Administrative Court ruled in favor of Dongin Pharm against the Ministry of Food and Drug Safety (MFDS), ruling a 'plaintiff victory' on the 10th.

 

Dongin Pharm filed a suit in the administrative court arguing that the MFDS' administrative measure related to the cancelation of imported item approval in May last year.

 

This rare disease treatment is used as a premedication regimen before autologous·allogenic stem cell transplantation in adult·pediatric patients with hematological diseases.

 

It is also used when high-dose chemotherapy in combination with stem cell transplantation is adequate for treating adults·pediatric patients with solid cancers.

 

This type of drug, with imported annual sales below KRW 200 million, faced several hurdles.

 

Initially, a medical device company imported a product called 'Thiotepa,' manufactured by US-based pharma company Bedford and distributed in South Korea.

 

However, concerns have been raised in the United States that environmental waste and carcinogens are hugely produced during the production of Thiotepa.

 

Therefore, the US-based manufacturer discontinued production of this drug, leading to discontinued import by the Korean importing company.

 

After that, the Korea Orphan Drug & Essential Drug Center responded.

 

The Korea Orphan Drug & Essential Drug Center secured 'Tepadina Inj' from Italia and began distributing in South Korea.

 

Then, Korean companies also began importing this drug.

 

Dongin Pharm received approval for the imported product 'Tepadina Inj 15mg·1g' with the same active ingredient.

 

This drug soon became included in the National Health Insurance reimbursement list.

 

On May 21st, the MFDS issued an administrative measure of cancellation of imported product approval for this drug.

 

The Ministry of Health and Welfare (MOHW) announced that the reimbursement of this drug will be discontinued the next day due to the decision of approval cancellation by the MFDS.

 

The announcement to suspend reimbursement was reversed within a day.

 

On that same day, the MOHW announced that the reimbursement status for this drug would be maintained.

 

The decision was made in response to a notification from the administrative court indicating that a suspension of execution had been filed.

 

It was due to Dongin Pharm filing a suspension of execution and an administrative suit.

 

In response to MFDS giving a cancelation measure of imported product approval, Dongin Pharm immediately filed a suit for withdrawing such measure and applied for suspension of execution until the ruling.

 

The court accepted the application for suspension of execution.

 

The lawsuit lasted over a year.

 

Dongin Pharm and MFDS appeared in court three times since September 2024 to argue whether cancellation measure of the imported product is appropriate.

 

Ultimately, the Seoul Administrative Court ruled in favor of Donging Pharm.

 

Therefore, Dongin Pharm, which imports Thio Spal-P, was relieved.

 

However, the MFDS has yet to decide whether to appeal.

 

In South Korea, three companies have received approval for imported rare disease treatments containing thiotepa.

 

Two pharmaceutical companies are distributing these drugs to South Korea, excluding a company without any import record.

 

However, Thio Spal-P is the only drug that is in injectable formulation.