Controversy over the manufacturing location of QTP104

The MFDS changed from domestic development to overseas development

The location of COVID vaccine, which was approved for phase 1 of clinical trial by South Korea's bio-venture Quratis on the 19th, is controversial.

 

Quratis vaccine is the first of its kind in South Korea, similar to Pfizer and Moderna.

 

However, the MFDS says the vaccine is an overseas development product and discriminates against other domestic development products.

 

On the 20th, the MFDS approved Phase 1 clinical trial plan for QTP104.

 

The clinical trial will be conducted for 36 people at Gangnam Severance Hospital, which is aimed at increasing capacity, multiplying institutions, disclosing and phase 1 of clinical trials to evaluate the safety of vaccines to prevent COVID-19 among healthy adults.

 

QTP104 is a self-replicating mRNA-based vaccine, which is known to produce more antigen proteins by inserting replication genes involved in self-explosion, unlike conventional mRNA vaccines.

 

QTP104 is the first RNA vaccine in Korea.

 

The COVID-19 vaccine, which is currently undergoing clinical trials in Korea, is a DNA vaccine from Genexine and Geneone, a virus vector vaccine from Cellid, and a recombinant vaccine from SK Bioscience and EuBiologics.

 

The RNA vaccine was first developed by Curatis.

 

The MFDS also marked Quratis' vaccine as a domestic development shortly after clinical approval.

 

However, since QTP104's original developer is a foreign company, it has changed to foreign development.

 

There was no press release that was distributing approval of vaccine for domestic development.

 

According to the clinical trial approval information, the original developer of QTP104 is HDT Bio Corp in the U.S.

 

But, HDT Bio also failed to commercialize the vaccine.

 

Quratis explains that QTP104 is a development vaccine in Korea.

 

A company official said, "Vaccines are manufactured at the Osong plant, and it is a vaccine developed in Korea.

 

We also asked the MFDS to change it to domestic development." However, the MFDS said, "No data related to domestic manufacturing have been submitted, and nothing has been officially applied for domestic development." There is also a new drug developed in Korea by bringing substances from overseas.

 

K-CAB (Tegoprazan), which was approved as Korea's new drug No.

 

30, is also said to have been introduced from Japan.

 

However, it is called a new drug developed in Korea because CJ Healthcare conducted a clinical trial for commercialization.

 

QTP104 can be said to be a new domestic development drug if Quratis gets permission first in Korea and has never been commercialized overseas.

 

The standards for overseas development are also unclear.

 

Until now, overseas development products are known to refer to multinational clinical trials by global pharmaceutical companies that are conducted not only in Korea but also in other foreign countries.

 

However, it is questionable whether the QTP104 will be considered multinational clinical even if partner companies are receiving clinical approval from the U.S.

 

and India and product development is underway.

 

This is because individual companies are conducting clinical trials in each country.

 

Quratis is a company that participates in the "Vaccine Business Council" led by the MOHW, and is also supported by the government.

 

Therefore, even if Quratis vaccine is commercialized later, controversy over whether it is a domestic or overseas vaccine is expected to continue.