Attention is focused on licensing domestic vaccines

Leading SK bioscience, Genexine, GeneOne, Cellid and Eubiologics expect Phase 3 clinical trials in the second half

Next year, Pfizer and Modena's vaccine prices will rise

As the supply price of COVID vaccines, which relies entirely on imported products, is confirmed to increase next year's supply price in Korea, it is necessary to develop the vaccine within this year.

 

Attention is focusing on the development status of Korean pharmaceutical bio companies, which are about to undergo phase 3 clinical trials, will be able to complete clinical trials as planned and obtain marketing permits within this year or in the first half of next year.

 

According to the pharmaceutical bio industry on the 4th, five companies approved by the MFDS, including Genexine, SK bioscience, GeneOne, Cellid, and Eubiologics.

 

The goal of the five companies is to obtain approval within this year for phase 3, which is evaluated as a phase just before commercialization, with phase 2 in progress or completed.

 

It takes time for Curatis and HK Inno.N to get a commercial license after receiving a relatively recent vaccine approval last month.

 

The development of a domestic COVID vaccine is urgently needed as the number of new confirmed cases of COVID patients in Korea is spreading and countries around the world are forced to distribute their own vaccine supplies.

 

U.S.

 

pharmaceutical companies Pfizer and Moderna have also decided to raise the supply price of their mRNA vaccines.

 

Therefore, domestic supply prices are expected to rise next year.

 

However, there is a long way to go to develop a domestic vaccine.

 

Major foreign media reported on the 1st that Pfizer and Modena will increase the price of a single dose of vaccine supplied to the European Union by 25% and 10%, respectively.

 

Pfizer raised its contract price from €15.5 to €19.5.

 

The price of a single Modena rose from €19 to €21.47.

 

The development of domestic vaccines is to ensure that Korea is not affected by such price hikes and fluctuations in volume of imported vaccines.

 

SK Bioscience is the fastest development among domestic pharmaceutical bio companies that are close to clinical phase 3, the final step for permission.

 

SK Bioscience submitted a clinical phase 3 plan for "GBP510," a synthetic antigen coronavirus development substance, to the MFDS in June.

 

SK Bioscience, which received approval for phase 2 and phase 3 in Indonesia last month, aims to receive commercial approval and release it in the first half of next year after receiving phase 3.

 

Genexine also received phase 2 and 3 of its DNA vaccine substance "GX-19N" in Indonesia last month.

 

Along with Genexine history SK Bioscience, it is evaluated to be the closest to clinical phase 3.

 

Cellid, which is developing the virus vector vaccine, Eubiologics and DNA vaccine developer GeneOne are also planning to enter phase 3 in the second half of this year and release the vaccine as early as the first quarter and second quarter of next year at the latest.

 

It is not yet clear whether Korean vaccines will be available as scheduled because phase 3 clinical trials take a long time.

 

Health authorities also have high expectations for domestic vaccine developers.

 

The MOHW has successfully deliberated on the National Assembly by deploying ₩98 billion in phase 3 support from five companies that have started developing domestic vaccines in the second revised budget this year.

 

Earlier in the year, Kwon Deok-chul, Minister of Health and Welfare, was convinced that domestic vaccines, which have been developed by the five companies since the beginning of this year, will enter commercialization with permission to market by the end of this year or early next year.

 

The government has allowed domestic vaccine developers to enter clinical trials relatively quickly.

 

The advantage of comparative clinical trials is that the number of subjects can be reduced to thousands of people compared to existing clinical trials, which require tens of thousands of people, significantly reducing clinical costs and time.

 

If domestic vaccines enter the commercialization stage of inoculation after obtaining market permits, they will have a positive impact on the stabilization of supply and demand in Korea and the reduction of confirmed cases.

 

It will not matter if the price of overseas development vaccines increases or supply and demand of supplies is unstable.

 

"In the mid- to long-term, securing vaccines in Korea is very important," said Sohn Young-rae, head of Central Disaster Management.

 

"In addition to the price issue, there are only a few vaccine supply pharmaceutical companies worldwide, and all countries are willing to purchase them, so buyers are inferior to suppliers in the negotiation process," he said.