Domestic COVID-19 vaccine developers at a crossroads

HK Inno.N also discontinues trial

“Many people already became immune”… HK InnoN becomes second company to discontinue development after Genexine

Only SK Bioscience and Eubiologics enters Phase III trial… Concerns of the other 5 companies deepen

HK Inno.

 

N announced it will voluntarily discontinue the development of its COVID-19 vaccine due to the sudden change in the spread of COVID-19 in Korea.

 

With the marketing approval of SK Bioscience’s COVID-19 vaccine imminent, the indecisiveness among the other vaccine developers in Korea is increasing According to industry sources on the 10th, HK Inno.

 

N has decided to discontinue the development of its COVID-19 vaccine, ‘IN-B009’ in Korea.

 

The company had been developing a recombinant vaccine, the same as SK Bioscience’s GBP510 or Novavax’s Nuvaxovid in terms of platforms.

 

The company pointed to the rapid change in the Korean COVID-19 situation as a reason for discontinuing its trial.

 

Unlike in July last year when HK Inno.

 

N received approval for the Phase 1 trial of IN-B009, the company said the need for COVID-19 vaccines had reduced significantly.

 

HK Inno.

 

N said, “Most of the people in Korea have secured immunity to COVID-19, being infected or through multiple vaccinations.

 

The COVID-19 situation has now changed rapidly.

 

With the situation moving to the endemic phase, there is no clear purpose for us to enter a late-stage clinical trial." ◆Second company after Genexine to discontinue development… 7 companies remain The company became the second after Genexine to drop the development of its vaccine.

 

Before HK Inno.

 

N, Genexine had announced that it will voluntarily discontinue its Phase II and Phase III trials in March.

 

At the time, Genexine also explained that it “determined that the business feasibility of GX-19N was low in the rapidly changing COVID-19 market in consideration of the global vaccine supply and demand.” With Genexine and HK Inno.

 

N’s voluntary withdrawal, 7 domestic COVID-19 vaccine developers now remain in the market.

 

The companies that remain are SK Bioscience, Eubiologics, Cellid, Geneone Life Science, Quratis, Eyegene, and ST Pharm.

 

Among the companies, SK Bioscience’s GBP510 is soon to be commercialized.

 

On the 29th of last month, the company applied for the marketing authorization of GBP510 under the name ‘SKY Covione.’ The drug is currently under review by the Ministry of Food and Drug Safety and is likely to receive an approval within the month.

 

Eubiologics is continuing the development of its‘EuCorVac-19’ through a global Phase III trial.

 

After receiving approval for its trial in three countries in Africa, Eubiologics also initiated a Phase III trial in the Philippines on the 7th of this month.

 

As such, the company has entered Phase III trials by securing a comparator vaccine overseas.

 

In Korea, the company also received approval for its Phase 3 trial protocol and is in search of comparator vaccines.

 

◆ Companies change trial plan due to low marketability…concerns deepen among developers Excluding the two, no other company has entered Phase III trials yet.

 

The industry is paying attention to the possibility that more companies will stop developing COVID-19 vaccines.

 

Cellid has started its Phase IIb trial for 'AdCLD-CoV19-1' in Korea.

 

Cellid has prepared a two-track strategy to continue clinical trials for its vaccine for primary inoculation that was in development while developing another vaccine as a booster shot (additional inoculation).

 

Geneone Life Science changed its strategy from developing a vaccine for primary inoculation to developing a booster vaccine.

 

Last month, the company announced that it had completed the registration of subjects for the Phase IIa clinical trial of 'GLS-5310', which is being developed as a DNA vaccine.

 

After confirming the safety and efficacy of clinical trials in a Phase IIa trial, the company plans to continue on studying its vaccine through Phase IIb and III trials as a booster vaccine.

 

The changed COVID-19 situation is analyzed to have played a decisive role in the changes in the development strategy of the two companies.

 

With the COVID-19 pandemic entering the endemic stage, the market competitiveness of vaccines has been greatly reduced.

 

The other companies are having difficulty in the patient recruitment stage.

 

Quratis and Eyegene received approval for their Phase I and Phase I/2a trial in July and August last year but are still recruiting patients.

 

ST Pharm has received approval for the Phase I trial plan of its mRNA platform-based 'STP2104' in March this year and is starting to recruit patients.