World’s 2nd stem cell drug batch to get thumbs-up: A new batch of stem cell-based medicines—only the world’s second so far—is set to be approved this month by South Korean authorities.
Two South Korean biotechnology firms expect their stem cell drugs—Cartistem, a treatment of damaged cartilage produced by Medipost Inc. and a stem cell-based anal fistula drug by Anterogen Co.— to be approved by the Korea Food and Drug Administration (KFDA)
Medipost’s Cartistem is a drug for treating degenerative arthritis and knee cartilage defects.
“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.
If Cartistem and Anterogen’s anal fistula treatment medicine get the green light, they could be available on the market within a month or two, according to market watchers.
According to experts, because the drugs do not use analogous stem cells from patients, these can be mass-produced and its quality can be maintained better but stem cells from other people.
Last July, South Korea became the world’s first country to approve a stem cell-based drug called Hearticellgram-AMI that is used to treat acute myocardial infarction.
The drug is produced by FCB-Pharmicell, a company based in Seongnam, south of capital city Seoul.
Stem Cell is a Medicine: Korean Supreme Court Ruling
04 November 2010
Are stem cells considered as medicines? If you are in South Korea, the answer — according to a recent Supreme Court decision — is “Yes”. Hence, stem cell therapies must require approval from the Korea Food and Drug Administration before they are administered on patients.
According to the Korea Times, the Korean Supreme Court upheld a lower court’s decision which ruled in favor of patients who underwent stem cell transplantation in a Seoul clinic but “found no improvement”.
More from Korea Times:
Justice Min Young-il ruled in favor of 60-year-old Choi and eight others who filed a suit against Kim, an operator of a clinic in Seoul, because the stem cell transplantations they had received were not as effective as they were told they would be.
Min said, “Stem cell use is considered a medicine if it was extracted from the human body for treatment purposes. The clinic’s transplantation without approval from the Korea Food and Drug Administration is a violation of the Pharmaceuticals Law.
Moreover, the use of stem cells was still undergoing debate at the time and the practice was still in the experimental stage.”