Korea Set to Approve Stem-Cell Drugs for Cartilage Repair (Biloine Young @ OTW)
The officials of two South Korean biotechnology firms expect to receive Korean Food and Drug Administration (KFDA) approval for their stem cell drugs this month. Approval will pave the way for the world’s second stem cell-based medicines to enter the market.
The first drug is called “Cartistem”, produced by Medipost, Inc. for treatment of degenerative arthritis and knee cartilage defects. The second is a stem cell-based anal fistula drug made by Anterogen, Co. Officials of both companies expects their drugs to be approved by the KFDA by mid-January.
“We are currently reviewing documents additionally submitted by each company. Permission will be issued sooner or later,” a KFDA official said on condition of anonymity in the January 8 news release.
The makers of Cartistem use stem cells from donors, not from the patients involved, asserting that in this way the product can be mass produced and its quality better maintained. If the two stem cell products are approved, market watchers believe they will be commercialized within a few months.
In July, South Korea became the world’s first country to approve a stem cell-based drug named “Hearticellgram-AMI.” The medicine for acute myocardial infarction is produced by FCB-Pharmicell based in Seongnam, south of Seoul.