[Photo provided by GC Pharma]
South Korea’s biotech company GC Pharma is seeking to apply for conditional approval with the local health authority for its Covid-19 therapy after it completed the treatment’s phase two clinical trial last week.
According to multiple sources from the pharmaceutical industry on Wednesday, GC Pharma has completed registration of patients for the second phase clinical trial for GC5131A, its Covid-19 plasma treatment, as well as injection on Dec. 31.
GC Pharma has developed GC5131A – a therapy that uses blood plasma taken from convalescent donors after Covid-19 infections – and conducted the second phase clinical test on high-risk patients until the end of last year. The clinical trial was conducted at 15 medical sites in Korea.
An unnamed official from GC Pharma said that the company is compiling and analyzing the test data after it finished its injection to 60 patients. It aims to complete the remaining procedure by March and apply for conditional approval for use of the Covid-19 treatment with the Ministry of Food and Drug Safety.
The official noted that GC Pharma recently completed the production of the third batch of the cure, a move that will enable immediate use of the plasma therapy once the ministry gives a nod to its condition use.
The company has collected plasma from 4,126 out of 6,538 individuals who agreed to donate their blood with antibodies after they recovered from Covid-19.
GC Pharma’s plasma therapy for Covid-19 has already been prescribed to patients at medical sites under strict conditions. The therapy has been approved by Korea’s food and drug safety ministry for 30 cases under medical purpose. Since October, the cure has been used at different sites including Kyungpook National University Chilgok Hospital and Soon Chun Hyang University Hospital Bucheon until recently.
Under the country’s patient treatment scheme, a medicine – even if it is under clinical trial phase – can be used for special purpose to treat intensive care patients whose lives are threatened without other treatment options. The medicine can be used only by the hospital that has applied for approval and to the particular patient. The scheme is separate from the overall clinical trial or conditional approval.
GC Pharma shares finished Wednesday at 427,000 won ($393.08), down 3.06 percent from the previous day.
By Chung Ji-sung and Lee Eun-joo
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