GC Pharma

Status: Under Phase 1 clinical trial

A tissue factor pathway inhibitor (TFPI) causes blood coagulation via exogenous coagulation pathways. This mechanism may compensate for the FVIII or FIX deficiency in hemophilia-A or B patients. MG1113A is an anti-TFPI antibody being developed for prophylactic therapy for patients with hemophilia and coagulation inhibitors. In development for a longer in-plasma half-life, MG1113A is expected to increase the convenience of administration through subcutaneous injections and less frequent dosing in comparison to its competitors, such as Advate, Kogenate, and Eloctate.

Status: Under Phase 1 clinical trial

GC1123B is a treatment that inserts a device into the head and injects the drug directly into the ventricle to improve the problem that the drug of the existing intravenous injection formulation does not pass through the blood-brain barrier and does not reach the 'brain parenchyma'. Hunterase ICV is on the market after obtaining permission in Japan in 2021, and is currently undergoing phase 1 clinical trials in Korea.

Status: Under Phase 2 clinical trial

GC1118A is a fully human anti-EGFR (epidermal growth factor receptor) antibody that specifically targets colon cancer. The abnormal and excessive activity of the EGFR is responsible for the growth and metastasis of cancer, so GC1118A binds to the EGFR and blocks these growth signals, thereby inhibiting the growth of cancer cells. It also simultaneously gathers immune cells to release toxins that induce the death of cancer cells. Compared to other EGFR-targeting antibodies, GC1118A exhibits superior inhibitory activity against EGFR ligands in terms of high-affinity binding and mechanism. Phase-1a clinical trial has proven the safety and superior tolerability of the drug. With an appropriate dosage determined in conjunction with the continued administration of chemotherapy in Phase-1b trial, Phase-2a trials are now underway with an increased number of patient participants to assess GC1118A’s safety and efficacy.

Status: Under Phase 2 clinical trial

Anthrax is a zoonotic disease caused by the spore-forming bacterium known as Bacillus anthracis. Anthrax occurs in humans in three forms: cutaneous, gastrointestinal, and respiratory. Today, Bacillus anthracis is considered one of the deadliest weapons in bio-warfare and bioterrorism because the spores can persist in the given environments and readily cause infection via inhalation when aerosolized. GC1109 targets as its antigen the anthrax toxin which, in infection, serves as a receptor binder. This vaccine is obtained by cultivating and purifying genetically engineered Bacillus brevis. In the phases 1 and 2 of clinical trials, GC1109 has displayed an excellent safety profile and dose-dependent immunogenicity. Further clinical trials are currently at the planning stage.

Status: Complete Phase3 clinical trial in the US

GC5107B is a 10% concentration of intravenous immunoglobulin (IVIG-SN 10%) containing IgG antibodies purified from human blood plasma. It is intended to boost the immune systems of patients with PID. Since first successfully developing IVIG-5% in 1982, GC Biopharma has been upgrading its IVIG product, introducing a safer IVIG-S 5% (receiving government approval in 1996), IVIG-SN 5% (approved in 2010), and IVIG-SN 10% (approved in 2017) for the Korean public. These IVIG products have been exported overseas as well, particularly to countries in South America. GC5107B had been completed Phase 3 clinical trial in the United States to verify the safety and superior tolerability of the drug, as well as its efficacy for its official introduction into the North American market.

Status: Under Phase 3 clinical trial

Bacille Calmette-Guérin (BCG) is one of the first live-attenuated vaccines to be used in humans. It remains the most commonly used vaccine worldwide, with over 120 million doses administered each year. BCG provides protection against severe and disseminated tuberculosis or tuberculous meningitis. BCG has also been connected to reduced infant mortality (as it protects infants against potential tuberculosis infection) and also reduced risk of tuberculosis infection in adults. The WHO recommends that the BCG vaccine be given to all children born in countries where tuberculosis is highly endemic in order to protect against TB meningitis and military TB. GC Biopharma's manufacturing facility for the BCG vaccine, in operation since 2011, produces over 30 million doses per year.

Status: Marketed in Korea

Varicella, commonly known as chickenpox, is an acute infection caused by varicella zoster virus (VZV). Major symptoms include itching, rashes, droplet-shaped blisters, and scabs all over the body. The incidence rate is highest among young children aged two to eight, with infections spreading either by air (through respiratory droplets) or direct contact. Although the vast majority of pediatric patients recover completely, in rare cases, some may develop serious complications, such as secondary bacterial infections, pneumonia, and encephalitis, and may even result in death. In 1994, GC Biopharma became the second company in the world to develop a varicella vaccine (Suduvax) using VZV isolated from the blisters of Korean patients. The product, marketed in Korea for 25 years, also became the first and only varicella vaccine produced in Korea to be exported, starting in 1998. GC Biopharma is now upgrading Suduvax into MG1111, aiming at greater productivity and better quality, by changing the cell line and the manufacturing process. BERYCELA, upgraded from Suduvax, obtained a government approval in March 2020 and launched in 2021. The product get WHO PQ certification in February 2023.

Status: Approved in China

GC 1101D (GreenGene F) is a B-domain deleted recombinant human factor VIII for the treatment of hemophilia A, whose sufferers have a genetic deficiency (deletion or mutation) in clotting factor VIII and are therefore prone to increased bleeding episodes. GC1101D can replace endogenous factor VIII and help stop such bleeding. The manufacturing process for GC1101D is designed to enhance product safety. To prevent contamination, raw materials of animal origin are strictly prohibited from the manufacturing process. In addition, virus inactivation and nanofiltration are employed for virus elimination. GC1101D was approved in 2010 in Korea and is on the market. Recently, GC Biopharma successfully completed Phase 3 clinical trial and approved in China(in 2021).

Status: Approved in Korea

GC2127A (Livmarli sol.) is a treatment of cholestatic pruritus in patients with Alagille Syndrome (ALGS) which is a rare disease. GC2127A is a Maralixibat-mediated blockade of intestinal reabsorption of bile acids by ASBT that interrupts the enterohepatic circulation, thereby increasing fBA excretion and lowering sBA levels. As the first treatment in Korea that can be used for pruritus in patients with Alagille Syndrome, it provided a treatment opportunity to patients who had previously suffered from itchy skin due to this disease. In addition, global clinical trials for biliary atresia are underway, and we plan to add indications through approval applications.