IV Globulin SN is one of GC Biopharma’s best globally known products, approved in 15 countries worldwide and exported amid growing demand to South America. Phase 3 clinical trials has been done in the United States and Canada. The project has been submitted the BLA based on the results of the clinical trials.
Hunterase, first approved in Korea in 2012, is the second Hunter syndrome treatment in the world to have been developed. Since launching the product on the Korean market, GC Biopharma has been preparing to introduce it onto the global market. It serves as evidence of the company’s advanced biopharmaceutical technology.
GC Biopharma aspires toward increasing Hunterase’s global market share to over 50 percent, thereby shifting the paradigm on Hunter syndrome treatment. The company also intends to continue to invest in treatments for various other rare diseases, including Fabry disease, to ensure effective treatment and better quality of life for struggling people in Korea and around the world.
BARYCELA (varicella II vaccine), which has improved product quality and safety compared with Suduvax, obtained domestic approval in 2020, and an application for WHO PQ has been submitted and is currently under review. The company expects the BARYCELA, once approved WHO PQ, to help the company expand its presence on the global vaccine market.
GCFLU, which was the first seasonal flu vaccine to have been government-approved in Korea in 2009, became the fourth seasonal flu vaccine in the world to pass the WHO prequalification program in 2011, proving its quality, safety, and efficacy to the world. Multidose vials, developed specifically for export, also passed WHO prequalification in November 2012.
GCFLU Quadrivalent (prefilled syringes), immunizing against one more strain of influenza virus subtype B in addition to the two strains of subtype A and another strain of subtype B, was the first of its kind to win government approval in Korea and the fourth in the world to win WHO approval in 2015. GCFLU Quadrivalent in single- and multi-dose vials was also the first vaccine of its kind to get approval in Korea for export. As of 2017, all vial types passed WHO prequalification to get ready for increasing its share of the global market.
GreenGene F is a third-generation recombinant protein treatment for hemophilia A, and the third such treatment in the world to have been developed. Epitomizing GC Biopharma’s unsurpassed technology and expertise, Phase 3 clinical trials has been done in the China. The project approved in China based on the results of the clinical trials.
The company expects the drug to generate immense added value to the Chinese pharmaceutical market, where there is great potential for growth. The company also plans to develop a new-generation and longer-acting hemophilia treatment for developed markets in North America and Europe.