S. Korea with genome editing treatment at the risk of being stranded

The world’s first treatment using genome editing technologies was approved in the U.K., followed by in the U.S. Genome editing is a technology to cut and correct the desired part of DNA in cells. This is the first time genome editing technologies were approved as a treatment in the U.S., the biggest medicines market in the world. As DNA can be directly corrected to treat diseases, it is expected to open a new chapter for treating rare hereditary diseases and incurable diseases, such as cancer.

The U.S. Food and Drug Administration (FDA) recently approved the use of genome editing treatment on patients with sickle-cell anemia, which is a condition that affects the shape of red blood cells from round to sickle due to a gene mutation. CRISPR, a third-generation technology that received the Nobel Prize in Chemistry in 2020, was used to develop the treatment. With CRISPR, stem cells are extracted from patients to cut out genes before transplanting them back to the patients. With just one treatment, a permanent cure is possible. The commercialization of genome editing treatments, which have been in the research stage, is expected to be accelerated with the recent approvals.

For the technologies themselves, South Korea is at the world-leading level. One of the three companies competing to earn patent rights for the development of CRISPR is South Korean. However, commercialization of the technologies is far behind in the country. Only limited areas are allowed for gene editing treatment research and clinical trials on humans are strictly regulated. Due to the lack of domestic clinical infrastructure, South Korean companies mostly pursue joint development with foreign pharmaceutical companies. Researchers at the College of Medicine of a South Korean university developed prime editing, a fourth-generation technology, to treat congenital retinal disease. However, clinical trials for the treatment have been slow due to the insufficient funds provided by the government.

Commercialization in the agricultural sector, where gene editing technologies are widely used, is practically prohibited in South Korea. A bill to partially ease regulations on genetically modified foods, such as hazard assessments, was proposed but hasn’t been passed by the standing committee of the National Assembly for over a year. As a result, South Korean companies that developed new products, such as tomatoes with vitamin D, have not been able to market them.

Gene editing is a core high-tech biotechnology that will drive South Korea's future growth. Relevant legal systems and regulations should be amended to enable proactive investment in R&D and grow the industry. It is quite absurd for South Korea to be behind other countries despite having source technologies.