As Americans and Britons approach herd immunity from Covid-19 thanks to homegrown vaccines, Koreans wonder whether and when they will do so.

In conclusion, Koreans are likely to receive homegrown vaccines early next year, as local developers of Covid-19 vaccines will soon get on the home stretch, according to industry sources. 

Korean pharmaceutical companies developing Covid-19 vaccines and treatments have recently presented their clinical trial results and are about to move to the next phase. Five Korean companies are developing Covid-19 vaccines, and 11 drugmakers are conducting clinical trials for therapies.

SK Bioscience plans to complete the phase 1/2 clinical trial of GBP510, a candidate for a Covid-19 vaccine, by the end of this month and wrap up the study results of another candidate, NBP2001. GBP510 entered phase 1/2 clinical trial at the end of 2020, and the company entered the second stage of phase2 trial.

SK Bioscience would select one of the two candidates with better efficacy and enter phase 3 with it. The company expects to commercialize the vaccine as early as early next year if the drug candidate verifies effectiveness without meeting any serious problem in the phase 3 study.

The company’s vaccine development is also expected to speed up as it received funds worth $210.1 million from the Coalition for Epidemic Preparedness Innovations (CEPI) for the research.

Genexine, a biotech company committed to next-generation antibody treatment, has confirmed the safety of the deoxyribonucleic acid (DNA) vaccine GX-19N in phase 1 clinical trial.

However, the study results published on medRxiv, an online web for unpublished preprints in the medical field, showed that the neutralizing antibody titer was 9.8 percent of those recovering from the disease.

The company plans to prove the efficacy of GX-19N again through the next phase of the clinical trial in progress or planned.

Other Covid-19 vaccine developers plan to run comparative clinical trials to head for the next phase study as the Ministry of Food and Drug Safety proposed.

Phase 3 clinical trials generally require tens of thousands of recruited patients, but many companies find it difficult as the number of patients has decreased due to vaccination. And that explains why the government suggested pharmaceutical companies check efficacy in comparative clinical trials to proceed to phase 3 study.

However, Genexine plans to continue conducting clinical trials as there is no commercialized vaccine using a DNA platform for clinical comparison.

The detailed results of Genexine’s GX-19N would require more time as there are ongoing and planned global studies, including phase 2/3 clinical trials to begin soon in Indonesia with its local partner Kalbe Pharma.

Cellid, a company specializing in a cell-based vaccine, also disclosed the interim results of its phase 1 study of the Covid-19 vaccine AdCLD-CoV19. In addition, the company started preparing for the late phase 2b/3 clinical trials.

The company has confirmed some safety and immunogenicity of AdCLD-CoV19 in the phase 1 study, and it has already manufactured vaccine candidates for phase 3 clinical trials.

Cellid entered the first stage of the phase 2 trial in March and completed administration, and it is collecting samples to analyze the result. The company aims at entering phase 2b study in July and phase 3 in September.

                          Covid-19 treatment developers also speed up process

Following vaccine developers’ introduction of their clinical progress and taking another step to commercialization, the Covid-19 drug developments have recently made progress.

Many health experts worldwide have foretold that humanity would have to live with the Covid-19 similar to seasonal flu, making the recent study results raise hopes for receiving homegrown products from early 2022.

Daewoong Pharmaceutical, which completed nasal administration of Coviblock (ingredient: camostat mesylate) in phase 2b study, plans to apply for conditional use in the third quarter of 2021.

In phase 2b, it will verify the efficacy and safety of Coviblock compared to placebo in the same way as the data analyzed for phase 2a trial with more patients. In addition, the company confirmed the possibility of Coviblock as a Covid-19 treatment in the previous phase 2a trial.

“We plan to complete phase 3 to commercialize Coviblock, and we will do our best to fulfill social responsibility as a pharmaceutical company,” Daewoong official said.

Korea United Pharm also received approval to proceed to phase 2 clinical trial of UI030 (ingredient: budesonide, arformoterol) for inhaled Covid-19 treatment from regulators last month. On Wednesday, the company said it confirmed UI030 effective against the Covid-19 variant.

As a result of cell experiments on the Covid-19 beta variant, Korea United Pharm found that its candidate showed excellent antiviral efficacy at a level similar to that of GH strain and alpha variant.

The company plans to prepare for the mutating Covid-19 virus by conducting tests to confirm efficacy in Brazil and India.

Celltrion, the only domestic company that received approval for its Covid-19 treatment, has confirmed its safety profile once again from the ongoing global phase 3 clinical trials.

“Administering our Covid-19 drug Regkirona to patients with mild to moderate symptoms significantly lowered the rate of worsening and helped recover quickly in the large global phase 3 clinical trials,” a Celltrion official said.

The official added that the company expects Regkirona to be prescribed more for patients in Korea and overseas as the efficacy and safety have been confirmed again through the study.

The company plans to submit the study results to global regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for official authorization of Regkirona.