Stem cell therapies in Korea that had remained at the research stage are starting to enter the market in earnest, buoyed by clinical results and expectations for regulatory easing. On top of that, momentum to relax restrictions on the use of embryonic stem cells, which had been blocked by regulations, is adding to expectations across the industry.
According to the industry on the 10th, Korean corporations developing stem cell therapies have recently come into the spotlight as overseas approvals and late-stage clinical results become visible.
Nature Cell, which is developing Jointstem, the world's first autologous stem cell therapy for severe osteoarthritis, is in talks with the U.S. Food and Drug Administration (FDA) on approval.
The company is currently about to enter phase 3 in the United States and plans to continue detailed discussions with the FDA in May for accelerated approval. Jointstem has already received Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy (BT) designations from the FDA and was included in the Expanded Access Program (EAP) for patients with no treatment options.
There has also been a first case of a stem cell therapy developed by a Korean corporation winning approval in Japan. ANTEROGEN's Allostem, a treatment for epidermolysis bullosa, received formal product approval from Japan's Ministry of Health, Labour and Welfare on the 3rd.
Used for an intractable chronic disease in which the epidermis and dermis separate due to genetic factors, causing blisters, this therapy was licensed out to Japan's I'rom Pharmaceutical in 2015, and I'rom Pharmaceutical handled the clinical trials and regulatory approval.
MEDIPOST is also picking up speed in global trials. It has launched a phase 3 trial in the United States with Cartistem, a cord blood–derived stem cell therapy, at the forefront, and is conducting large-scale patient studies centered on major North American medical institutions. Depending on the clinical results, its entry into the global market will be determined.
Separately, ENCell shortened the culture period of EN001, a next-generation stem cell therapy, from more than 40 days to about 20 days using its own cell culture technology, and based on this experience is conducting phase 1/2 trials for a sarcopenia treatment.
However, some say the industry's overall competitiveness still needs reinforcement. According to the Korea Institute of Science and Technology Information (KISTI), the United States (23.9%) and China (16.6%) lead in the share of papers in cell and gene therapy (CGT), including stem cell therapies, while India and Iran are also growing rapidly, with an average annual growth rate of 23.2% and 8%, respectively. In contrast, Korea ranks 13th in the world with a 2% share, indicating the need to expand the research base and recalibrate strategy.
Against this backdrop, changes in the regulatory environment are cited as a key variable that will determine the industry's trajectory. Recently, an amendment to the Advanced Regenerative Medicine Act that would expand the scope of the use of embryonic stem cell–based therapies was introduced in the National Assembly.
The core of the amendment is a change in how cells are secured. Previously, only the method in which hospitals collected cells directly from patients to manufacture therapies was permitted, and even facilities equipped with Good Manufacturing Practice (GMP) capabilities faced limits on cell processing facility approvals. Treatment was also only possible at specific hospitals that conducted the clinical studies.
If the amendment passes, therapies could be produced using cell lines established by outside institutions. Barriers to entry would fall, including allowing treatment using cells for which clinical trials were completed at other institutions.
The industry expects that commercialization of stem cell therapies will accelerate as mass production and standardization become possible.
In particular, S.Biomedics, CHA Biotech, and Mirae Cell Bio, which are developing embryonic stem cell–based Parkinson's disease therapies, are expected to benefit directly. Given that they have faced limits in clinical development and commercialization due to institutional constraints, regulatory changes are likely to act as a variable that could shift the market landscape.
An industry official said, "The recent results are meaningful in that they go beyond simple research progress and are approaching a stage where they can lead to actual patient treatment," adding, "If the regulatory environment also improves, the Korean stem cell therapy industry will enter a full-fledged growth phase."