IV Globulin SN is one of GC Biopharma's best-known globally recognized products, approved in 15 countries worldwide and exported to South America amid growing demand. Phase 3 clinical trials have been completed in the United States and Canada. The project has been submitted to the BLA based on the results of the clinical trials.
Hunterase, first approved in Korea in 2012, is the second Hunter syndrome treatment developed globally. Since its launch in the Korean market, GC Biopharma has been preparing to introduce it to the global market. This accomplishment stands as a testament to 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 investing in treatments for various 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 boasts improved product quality and safety compared to Suduvax, obtained domestic approval in 2020 and WHO PQ certification in 2023. The company expects that BARYCELA, upon acquiring WHO PQ approval, will contribute to expanding the company's presence in the global vaccine market.
GCFLU, the first seasonal flu vaccine to be government-approved in Korea in 2009, became the fourth seasonal flu vaccine in the world to pass the WHO prequalification program in 2011 successfully. This achievement proved its quality, safety, and efficacy globally. Additionally, multidose vials, developed for export purposes, obtained WHO prequalification in November 2012.
GCFLU Quadrivalent (prefilled syringes), which immunizes against an additional strain of influenza virus subtype B along with the two strains of subtype A and another subtype B strain, was not only the first of its kind to receive government approval in Korea but also the fourth in the world to gain WHO approval in 2015. Additionally, GCFLU Quadrivalent in both single- and multidose vials secured approval in Korea for export, marking it as the first vaccine to achieve this status. As of 2017, all vial types have passed WHO prequalification to prepare for an increased global market share.
GreenGene F is a third-generation recombinant protein treatment for hemophilia A, making it the third of its kind to be developed globally. Epitomizing GC Biopharma's unparalleled technology and expertise, Phase 3 clinical trials have been conducted in China. The project received approval in China based on the results of these clinical trials.
The company expects the drug to bring significant added value to the Chinese pharmaceutical market, with great growth potential. Additionally, the company has plans to develop a new-generation, longer-acting hemophilia treatment for developed markets in North America and Europe.