Giving blood plasma from patients recovered from the new coronavirus infection to the sick is emerging as a potential treatment of COVID-19.
However, a local company developing an immune globulin agent using the plasma of recovered patients said it had trouble getting the blood because of local regulations.
An immune globulin medicine has a mechanism similar to plasma treatment, transfusing the blood of a recovered patient to a new patient, based on the fact that plasma has immune antibodies against viruses.
However, unlike plasma treatment, an immune globulin agent only uses the immune globulin containing the necessary antibodies from the plasma, which increases efficacy and safety.
An immune globulin treatment can address concerns about the immune system’s rejection that may occur in plasma treatment.
GC Pharma on Thursday announced that it would develop an immune globulin drug against COVID-19. The company plans to apply the technology of manufacturing “hyperimmune globulin,” made by dividing up only immune proteins with various antibodies taken from the plasma of recovered COVID-19 patients.
The new hyperimmune globulin will be different from immune globulin, which consists of general immune antibodies, as the former contains more antibodies specific for COVID-19, the company said.
GC Pharma has already developed and commercialized hyperimmune globulins, such as Hepavic for hepatitis B, and Hypertet for tetanus.
As the investigational immunoglobulin drug will have similar mechanisms and manufacturing procedures, the company will be able to develop it rapidly, it said.
Many other companies are working on a COVID-19 treatment using antibodies, which will take a long time to discover candidates and conduct trials. In contrast, an immunoglobulin agent can save development time, GC Pharma said.
On March 31, the U.S. Food and Drug Administration said approved plans for trials to use plasma from recovered COVID-19 patients to treat other patients.
Earlier, a Chinese study showed positive results of plasma treatment in COVID-19.
In Korea, Severance Hospital also conducted plasma therapy for severe COVID-19 patients.
Worldwide, the development of immune globulin therapies is gaining momentum. Multinational pharmaceutical firms, including Takeda and Grifols, have begun developing immune globulin treatments with the support of the Japanese and Spanish governments, respectively.
However, GC Pharma in Korea said it has yet to receive government support.
To develop an immune globulin, the company must secure plasma from recovered patients. Still, the local regulations barred it from getting sufficient blood.
Under the law, donated blood products can be used for research purposes only when they are considered ineligible for mass production. The regulations have remained unchanged even after the COVID-19 outbreak, holding back the development of immune globulin therapies, industry watchers said.
GC Pharma has spent more than a month to discuss with the Korea Centers for Disease Control and Prevention (KCDC) to get the blood from recovered COVID-19 patients.
Former Prime Minister Lee Nak-yeon, who heads a committee to get over the COVID-19 crisis, said the nation faced a war situation against the virus pandemic.
“We should abolish regulations drastically,” he emphasized during a visit to the headquarters of GC Pharma on Wednesday.
An official at GC Pharma said once the company secures plasma of recovered patients, the company could quickly complete the preparation for clinical trials.
“We hope to commercialize it within this year so that it can be used as an alternative for severe COVID-19 patients who do not respond to other treatments such as an antiviral drug,” he said.
<© Korea Biomedical Review, All rights reserved.>