Who’ll be the 2nd Korean-made COVID-19 drug?

GC Pharma plans to submit application next month for its plasma treatment

Bukwang wrapping up Phase II trial, more coming from Daewoong and Shin Poong

Product image of Nafabeltan

Chong Kun Dang’s candidate COVID-19 treatment Nafabeltan has failed to get the South Korean health authority’s conditional approval.

 

As the Ministry of Food and Drug Safety (MFDS) shut the first door of conditional approval to highly anticipated candidate Nafabeltan, the public is now curious of who would be the next second South Korean-made COVID-19 treatment.

 

Currently, the public highly anticipates of GC Pharma’s investigative plasma treatment.

 

Also the anticipation on Bukwang Pharm, Daewoong Pharmaceutical and Shin Poong Pharm are heightening as well.

 

◆MFDS “Needs additional clinical trial,” Chong Kun Dang “Phase III clinical trial planned” On Mar.

 

17, MFDS announced the result of the COVID-19 Treatment Advisory Panel’s discussion on the candidate’s efficacy and safety.

 

The Advisory Panel stated approving Chong Kun Dang’s Nafabeltan as a COVID-19 treatment, only based on the Phase II trial outcome would be inappropriate.

 

They added it would need further clinical trial to be approved as a COVID-19 treatment.

 

On Mar.

 

18, Chong Kun Dang announced its official position through an official statement.

 

The statement explained, "The company has not received any official notification of the conditional approval rejection from MFDS.

 

The related news would be officially announced immediately after the company receives an official notification." To this date in South Korea, Celltrion’s Regkirona (regdanvimab) was authorized as the first domestic COVID-19 treatment on last Feb.

 

5.

 

After Celltrion snatched the honorable title first, the public started talking about Chong Kun Dang, GC Pharma, and Daewoong Pharmaceutical as the second domestically developed treatment.

 

Among them, Chong Kun Dang was evaluated to be closest.

 

In fact, Chong Kun Dang was the first of the three companies to apply for conditional approval to MFDS on Mar.

 

8.

 

◆GC Pharma “Approval application to be submitted in April,” while Bukwang, Daewoong and Shin Poong clinical trials well in process

As the conditional approval on Chong Kun Dang’s Nafabeltan fell through for now, the interest of the pharmaceutical industry is again focused on the GC Pharma.

 

Among all candidates of the second South Korean-made COVID-19 treatment, GC Pharma’s is considered to show the fastest progress.

 

GC Pharma is developing a plasma treatment named, ’GC5131A'.

 

On last Dec.

 

31, the company completed the administration of the drug on the Phase II participating patients.

 

Currently, related data is being analyzed and organized.

 

GC Pharma official said, "After completing data analysis within the first quarter, we plan to apply for approval to MFDS in April." The increasing cases of treatment-purpose use approval are also heightening the anticipation.

 

According to MFDS, GC5131A has received approval for a total of 41 therapeutic uses since October last year.

 

The public’s interest on Bukwang Pharm, Daewoong Pharmaceutical and Shin Poong Pharm is rising as well.

 

Similar to Chong Kun Dang, the three companies are in process of repurposing an existing drug.

 

Bukwang Pharm says that it is in the final stage of Phase II clinical trial.

 

Bukwang Pharm is developing its own hepatitis B virus treatment, Levovir as a COVID-19 treatment.

 

The Phase 2 clinical trial has completed administering 60 participants.

 

Currently, the company is analyzing the gathered data for MFDS submission.

 

Daewoong Pharmaceutical is repurposing a camostat-based chronic pancreatitis treatment Foistar as a COVID-19 treatment.

 

The outcome of Phase IIa trial announced last year concluded the drug has statistically failed to meet the primary endpoint (cessation of viral shedding).

 

However, the drug confirmed a meaningful improvement in symptom, which was a secondary end point.

 

Based on the findings, Daewoong Pharmaceutical is currently conducting three cases of Phase IIb and Phase III trials—Phase II/III to evaluate Foistar’s efficacy and safety, Phase III to evaluate the candidate in combination with remdesivir and Phase III to evaluate the preventive effect against COVID-19.

 

The specific plan for the approval application has not been disclosed.

 

The company’s clinical trial protocol submitted to MFDS stated the trials would be done by coming December, but they could conclude earlier depending on the circumstances.

 

Apparently, the company has not decided to apply for the full authorization after the Phase III trial is done, or for conditional authorization before completing the trial.

 

Shin Poong Pharm plans to complete the Phase 2 clinical trial next month.

 

Shin Poong Pharm’s trial is investigating the company’s malaria treatment, Pyramax, as a repurposed drug.

 

The company announced that 76 out of 110 target patient size have been administered for Phase II trial as of Mar.

 

5.

 

In order to expedite the progress of the remaining clinical trials, the company has added three clinical trial institutions to the existing 13.