Phase 2/3 Trials for Hepatitis B Immunoglobulin: GC Pharma Receives Approval

GC Pharma, earlier known as Green Cross, it has received approval from the Ministry of Food and Drug Safety to proceed with phase 2/3 clinical trials for GC1102, a new recombinant hepatitis B immunoglobulin.

GC1102, otherwise called Hepabig-quality, employs immunoglobulins made from genetic recombination technology as its primary treatment source and prevents the recurrence of hepatitis B virus infection following liver transplantation.

Phase 2/3 Trials for Hepatitis B Immunoglobulin: GC Pharma Receives Approval


Genetic recombination technology has broad applications in drug developments, including insulin and growth hormone. growth, there have been no successful cases of hepatitis B immunoglobulin using the technology, making the company’s treatment closest to commercialization around the world.

The phase 2/3 clinical trial, which is the final step in the development phase, will assess the optimal dose of Hepabig-gene and assess its efficacy against existing therapies for liver transplant recipients with hepatitis B as the underlying disease in nine medical institutes.

As indicated by the company, the treatment’s purity is higher than that of the existing plasma-derived product. It additionally has high virus-suppressing capabilities and decreased drug administration time than conventional drugs.

The drug administration time can also fall to one-sixtieth of that of the conventional product. Additionally, since the issue of limited imports of special plasma, which is the raw material of existing products, is eliminated with, it is possible to respond flexibly to demand.

Such viewpoints can prompt a reduction in manufacturing cost, which can reduce the burden on the patient.

Based on the drug’s improvements, both the U.S. Food and Drug Administration and European Medicine Agency assigned orphan drug status to it in 2014.

GC Pharma President Hun Eun-chul said, “At presently available treatments that are effective for hepatitis B recurrence following liver transplantation are hepatitis B immunoglobulin derived from human plasma”.

“GC1102, which does not contain plasma-based additives, may offer innovative and more effective alternatives, as there are no other recombinant treatments available.”

The company believes GC1102 can possibly change the current treatment paradigm for hepatitis B patients, Huh included. The phase 2/3 clinical trials are required to take around five years to complete.


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