Korea is rising as a global biopharmaceutical power based on its outstanding biotechnology infrastructure, advanced clinical study, and world-class IT technology. Korea’s Hearticellgram-AMI (Pharmicell) is the world’s first stem-cell therapy product to gain approval for marketing. In 2012, Hunterase (Green Cross) became the world’s second medicine developed to treat Hunter syndrome and has been designated as an orphan drug by FDA. Currently, four out of seven globally commercialized stem-cell therapy products have been developed and manufactured by Korean companies (Hearticellgram-AMI, Cartistem, Cupistem, and Neuronata-R). The therapy (AFSTYLA) for adults and children with hemophilia A by SK Chemicals is the first Korean made bio medicine approved by U.S. FDA in 2016. Korea also boasts advanced production facilities for biopharmaceuticals.
The production facilities within the Incheon Free Economic Zone, with a current capacity of 500,000 liters a year, will be upgraded to an annual capacity of 1,090,000 liters in the near future. This upgrade is expected to help the Incheon Free Economic Zone emerge as the world’s largest biopharmaceutical production base. Korea is now the global biopharmaceutical powerhouse boasting excellent manpower and infrastructure with top-level clinical study capcity and IT platform. The level of bio-pharmaceutical technology of Korea ranks 4th after the U.S., the EU and Japan.