GC Pharma gives up commercializing Covid-19 plasma therapy

GC Pharma said it withdrew its application for a conditional nod for GC5131, an investigational Covid-19 plasma therapy.

GC Pharma said it would drop its effort to commercialize GC5131, a plasma therapy candidate for the treatment of Covid-19.

On Friday, GC Pharma said in a public filing that it would withdraw its application for a conditional nod for GC5131.

On April 30, the company sought the Ministry of Food and Drug Safety’s conditional approval for the plasma therapy. However, the ministry rejected the application, asking the company to submit additional clinical trial results to confirm the experimental treatment’s effect.

In response to the rejection, GC Pharma said that it would not dwell on getting the license for the plasma therapy.

The latest public filing signaled that GC Pharma virtually gave up commercializing GC5131, industry watchers said.

GC Pharma decided to accept the regulator’s review opinion and voluntarily canceled the permit application in the filing.

According to the public disclosure, GC Pharma would keep supporting the use of GC5131 for therapeutic purposes, cooperate with the National Institute of Allergy and Infectious Diseases for research on GC5131’s effectiveness on the Covid-19 virus variants, and conduct a three-year immunogenicity study by measuring neutralizing antibodies of convalescent Covid-19 patients.

However, the company did not mention whether it would conduct a phase-2b or phase-3 trial of GC5131.

GC Pharma’s move contrasts with that of Chong Kun Dang, another developer of a homegrown Covid-19 treatment.

Chong Kun Dang had been repositioning pancreatitis drug Napabeltan (ingredient: nafamostat) into a Covid-19 drug but failed to obtain conditional approval in March.

However, the company said it would conduct a phase-3 study to submit data requested by the ministry.

On April 16, the ministry granted the nod for a phase-3 trial of Napabeltan for the treatment of Covid-19.

Some observers said GC Pharma could continue to supply GC5131 for therapeutic purposes only. However, since the regulator gave the first temporary approval for GC5131 to be used at a hospital for Covid-19 treatment in October last year, it has granted 47 approval to hospitals to use GC5131 to treat Covid-19 patients.

“Under the Pharmaceutical Affairs Act Article 34 Paragraph 4, GC5131 can be used as an investigational clinical drug for therapeutic purposes,” a ministry official said.