Two South Korean biotechnology firms are expected to receive government approval for their stem cell drugs this month, paving the way for the world’s second batch of stem cell-based medicines to hit the market, sources said Sunday.
The Korea Food and Drug Administration will likely approve “Cartistem” produced by Medipost Inc. for treatment of damaged cartilage in mid-January, they said. A stem cell-based anal fistula drug by Anterogen Co. will also receive official permission within this month.
“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.
Medipost’s Cartistem, in particular, is a drug for treating degenerative arthritis and knee cartilage defects.
The drug uses stem cells from other people, not from patients, so that it can be mass-produced and its quality could be better maintained, experts said.
If Cartistem and Anterogen‘s anal fistula treatment medicine get the green light, they could be commercialized within one or two months, according to market watchers.
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. (Yonhap News)