IV Globulin SN is one of GC Pharma’s best globally known products, approved in 15 countries worldwide and exported amid growing demand to South America. Phase 3 clinical trials—the final step toward FDA approval—are underway in the United States and Canada. Phase 3 clinical trials by 13 sites ongoing in the United States and Canada.
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 Pharma has been preparing to introduce it onto the global market. It serves as evidence of the company’s advanced biopharmaceutical technology.
GC Pharma 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.
Suduvax, the second varicella vaccine in the world to have been developed and the first-ever such vaccine to have been produced in Korea, is a live attenuated vaccine recognized for its safety and efficacy. The vaccine today is distributed worldwide via the WHO/Pan-American Health Organization (PAHO).
With the goal of upgrading the cell line for the vaccine so as to enhance its productivity and competitiveness on the global market, GC Pharma has initiated the research and development of Suduvax II. The company expects the new varicella vaccine, once developed, 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 Pharma’s unsurpassed technology and expertise, the drug successfully completed Phase 3 and is currently under NDA approval process in China.
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.