[Photo provided by GC Pharma]
GC Pharma will file for conditional approval of its investigational blood plasma-derived coronavirus therapy GC5131A with the Ministry of Food and Drug Safety as early as this week.
If approved, GC5131A will be the country’s first blood plasma cure for the disease and second indigenous Covid-19 cure following Celltrion’s antibody therapy Rekirona.
GC Pharma is the only developer of a Covid-19 medicine based on blood plasma from convalescent patients in Korea.
Shares of GC Pharma closed 2.24 percent higher at 365,000 won on Monday.
According to GC Pharma on Sunday, the company already completed a Phase 2 trial on 60 high-risk patients with pneumonia, old age or underlying conditions, and an application for conditional approval will be submitted early next month based on clinical results. Approval is expected to come in May or June, and GC Pharma plans to provide the therapy to Covid-19 patents for free in Korea.
GC5131A has already been used to treat patients at 10 designated hospitals under a treatment-purpose approval system since October last year. Treatment-purpose approval allows health authorities to grant approval on using an unapproved investigational drug for urgent patients with a life-threatening condition that has no alternative therapies available.
As a blood plasma drug, GC5131A can quickly respond to mutant viruses or a surge in demand through mass production.
The blood plasma therapy is made after extraction and concentration of various virus neutralizing antibodies from a patient who has recovered from coronavirus infection. For this reason, it can be used as a treatment for most mutant viruses unlike Celltrion`s Rekirona, which targets only specific antigens.
By Kim Si-gyun and Minu Kim
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