Domestic companies are rolling out developments on stem cell treatments, leading to rising speculation on which will be the first to be approved this year.
Pharmicell’s Hearticellgram-AMI snagged the first domestic approval in 2011, followed by Medipost’s CARTISTEM and Anterogen’s ALLO-ASC-DFU gaining the nod in 2012, and Corestem’s Neuronata R Injection getting approved in 2014.
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Outside of Korea, three products - Osiris Therapeutics’ Prochymal, Chiesi Farmaceutici’s Holoclar, and Terumo’s HeartSheet – have appeared in the market after gaining approval.
The numbers indicate that domestic firms are developing four out of the seven approved stem cells therapies.
Against this backdrop, Nature Cell’s Jointstem, which was expected to become the eighth approved stem cell treatment, has run into an unfavorable situation in the approval process.
Although the company aimed to commercialize Jointstem by applying for conditional approval, the Ministry of Food and Drug Safety (MFDS)’s Central Pharmaceutical Affairs Council concluded it was not valid for conditional approval.
Nature Cell is also conducting clinical trials on AstroStem for Alzheimer’s and Vascostem for Buerger's disease. The company plans to knock on the ministry’ door to get a rare disease designation and drug approval of Vascostem.
While Jointstem is staging an uphill battle, Pharmicell’s Cellgram-Liver for cirrhosis is emerging. Pharmicell applied for the ministry’s conditional approval for Cellgram-Liver at the end of last year.
If Cellgram-Liver passes through the Central Pharmaceutical Affairs Council’s examination, it will become the first stem cell treatment drug to be approved this year.
Medipost is developing Pneumostem, a therapy for bronchopulmonary dysplasia in premature infants, and Neurostem, a treatment for Alzheimer’s.
Besides, Anterogen is conducting clinical trials for Chron’s disease with ALLO-ASC-CD, diabetic foot ulcers with ALLO-ASC-DFU, and epidermolysis bullosa with ALLO-ASC-EB.
Kangstem Biotech is conducting clinical trials for therapies aimed at treating atopy with Furestem-AD, rheumatoid arthritis with Furestem-RA, degenerative arthritis Furestem-OA, and Chron’s disease and psoriasis with Furestem-CD.
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