Covid drugs coming, but not Korea-made vaccines

A pharmacist at Daegu Dongsan Hospital holds up a vial of Celltrion's Regkirona on April 17. [YONHAP]

Three more Korea-made Covid-19 treatments are trying to get conditional use approval this year, with one filing the paperwork in two weeks.

Vaccines are a different story and companies' progress so far suggests Korea-developed jabs are unlikely to reach the market this year.

According to information from the Korea Health Industry Development Institute (KHIDI) shared by lawmaker Jeon Bong-min on Monday, four Covid-19 treatment candidates were funded by the government so far.

Following Celltrion's antibody drug CT-P59, or Regkirona, which received conditional use approval in February, GC Pharma's GC5131A is next in line to be recognized as an official Covid-19 treatment.

The company completed Phase 2 clinical trials in late December and is in the process of analyzing test results. It will apply for conditional use approval this month. This means GC5131A could be made available for nation-wide distribution to local hospitals, on the condition that GC Pharma conducts and submits Phase 3 clinical trial results afterwards.

"If the papers are filed as planned this month, conditional use approval will most likely come in May or early June," said a GC Pharma spokesman. "We've manufactured and stocked volumes of GC5131A that could be distributed in the market once the approval is granted."

If conditional use is approved, GC5131A will be the second Korea-made Covid-19 treatment and the first plasma treatment to receive the nod.

Produced using blood plasma of recovered Covid-19 patients, GC5131A has already proved its safety and efficacy to a certain degree as the drug candidate was allowed for emergency use on 43 patients in the country. The first recovered recipient was reported in December.

Permissions are granted in individual cases when a patient's doctor concludes the unauthorized drug is the only option. GC5131A was the most requested Covid-19 drug candidate.

The other two government-funded treatments are being developed by Daewoong Pharmaceutical. Both are regenerated drugs, meaning they were previously authorized to treat other diseases. They will apply for conditional use approval in second half of the year.

One, called DWRX2003, has completed Phase 1 clinical trials and is preparing to obtain approval for Phase 2 tests. The other, Foister tablets, are going through Phase 2 and 3 clinical trials at the same time, but the number of participants receiving the drug has not yet reached a goal set by Daewoong.

Of the four government-funded treatments, the largest budget was allocated to Celltrion's CT-P59: 52 billion won ($46.6 million) to be used on Phase 1, 2 and 3 clinical trials. GC Pharma was granted 5.8 billion won, while Daewoong received a total of 13.2 billion won for the two candidate substances.

Apart from these government-backed players, another company in the domestic race for Covid-19 treatments is Chong Kun Dang.

On Friday, the company announced its pancreatitis drug Napabeltan, or nafamostat mesylate by substance name, was going into Phase 3 clinical trials to test its efficacy as a Covid-19 treatment. The test is planned to be run on 2,440-or-so coronavirus patients in Australia, New Zealand and India.

Napabeltan failed in an attempt last month to receive conditional use approval using Phase 2 clinical trials obtained in Russia. Korea's drug authorities turned down the request, asking for additional data proving the candidate drug's clinical efficacy.

The new plan is to try again with Phase 3 trial results.

"It's hard to say when the Phase 3 clinical trials will be over so at the moment we don't have a definite timeline," said a Chong Kun Dang spokesman.

The progress in Korea-made Covid-19 vaccines is even slower: All five government-funded vaccine projects are in early stages of Phase 1 or Phase 2 clinical trials. Phase 3 trials may come in the second half of the year.

Lawmaker Jeon, who is also a member of the National Assembly's Health and Welfare Committee, said the possibilities were slim that any of them would succeed in receiving government authorization by year's end.

"There have been mounting concerns about Covid-19 vaccines in the country, which makes local development all the more important," he said in a Monday statement. "The government needs to come up with swift action to ease public anxiety."

For Covid-19 vaccines, the government has offered funding totaling 34 billion won so far to five projects. This was smaller than the 71 billion won R&D budget set for Covid-19 treatments.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]