SEOUL, South Korea – South Korean companies focused on research and development of stem cell therapy products are working hard to put the country back into a position of global leadership, even after setbacks in the last decade that held back research for years.

Stem cell research is a key priority for the country's growing biopharmaceutical sector. The importance given to the space was evidenced during the first Biopharma Korea Convention in Seoul on Oct. 21 and 22. Half the conference was dedicated to stem cell research.

"Korea has been doing constant research in this area. It's a industry hotspot," said Eunsook Yi, business development manager at Green Cross Holdings Corp., a biopharmaceutical company based in Yongin. "Our company is also looking into this field. That's why I'm here."

Regulators in South Korea have already approved four different stem cell therapeutics for marketing: Pharmicell Co. Ltd.'s Hearticellgram-AMI for acute myocardial infarction; Medipost Co. Ltd.'s Cartistem for knee cartilage defect; Anterogen Co. Ltd.'s cupistem for anal fistula in Crohn's disease and Corestem Co. Ltd.'s Neuronata-R for amyotrophic lateral sclerosis.

By the end of March, the number of ongoing clinical trials linked to stem cell products had risen to 40, according to South Korea's Ministry of Food and Drug Safety (MFDS). By this measure, South Korea is second in the world to the U.S., where there are 136 trials under way. China and Spain both have 17 each.

South Korea emerged as one of the most active producers of cell therapy research between 2008 and 2012. The growth in the output of research was rapid and companies managed to overcome a series of hurdles.

"We face a lot of challenges in compliance of regulations in terms of quality and manufacturing," said Hyun Soo Kim, president of Seoul-based Pharmicell, speaking about the challenges that companies in the field face during the convention.

In the last few years, the country has come a long way, said Kim.

"The Korean regulations [on cell therapies] nowadays are similar to the ones in the U.S. . . . When we tried to get into the R&D and phase I clinical trials, we consulted American experts and our data submitted to the U.S. FDA was accepted as valid."

The use of stem cell technology to treat the human body dates back to 1956. Hematologists started to culture cells for human use in 1997 and the first cell therapies hit the market in the U.S. in 1998, shortly after the country introduced its first policies on stem cell therapies.

IN THE LEAD, EARLY ON

South Korea was not far behind. The country introduced regulations for the approval of stem cell therapies, categorizing them as pharmaceuticals, in 2002. It was one of the first countries in the world to move forward in this particular space.

"As researchers of cell-based therapy, we have to admit that since the regulatory body of Korea categorized them as pharmaceuticals, we should have paid attention to quality in the first place," said Kim. "But we didn't."

"We also tend to forget that clinical trial outcomes of these cell-based therapies depend on the manufacturing process as well," he added.

In the last decade, South Korea has accumulated plenty of experience in stem cell research but it has not accumulated similar experience in marketing the therapies.

"In [stem cell therapy] commercialization, we have a very short history," said Kim. "Most researchers are not familiar with drug development in the market."

South Korea is doing quite a good job of staying on par with international stem cell research, including global leaders like the U.S. and EU, said Kim and other industry executives at the South Korea event this week.

"The Korean [regulator] is constantly consulting with international regulatory bodies, so we are keeping up with global trends," said Kim.

That has a direct and positive impact on the operations of Korean companies.

"Theoretically we can apply [for approval] in any country in the world because of the similarity of the regulations in Korea and the U.S.," said Kyung Sun Kang, president of Seoul-based Kangstem Holdings Co. Ltd.

A DEEP SCAR

Korea was an international leader in stem cell research a decade ago, but a scandal involving research scientist Hwang Woo-Suk set the country back tremendously. At one point, the Korean government completely shut down research.

Hwang was convicted in 2010 for faking his research findings. He had earlier claimed to have succeeded in creating human embryonic stem cells by cloning, which raised hopes of finding cures for a range of diseases. Much of his work, some dating back to 2005, was found to be faked.

South Korea had allowed some limited research into embryonic stem cells based on the Bioethics and Safety Act, but such research was completely banned following the Hwang scandal. The ban held for three years and was lifted only after the government revised the Act.

Speeding up research is important for Korea, which is looking to emerge as a global biotech leader, developing a competitive advantage is important.

"At this moment, we also must think about what is going on in Japan," said Kang. "Japan has a separate Regenerative Medicine Law for cell products. They are really innovative when it comes to cell therapies."

In November 2013, Japan enacted the Regenerative Medicine Law, which categorizes and regulates three types of regenerative medical techniques. It also enables medical institutes to outsource processing cell cultures to non-medical institutes.

And in Japan and China, both health and drug administration departments are managing the development of cell therapy. Japan has adopted a double-track method for the approval of cell therapies that allows for products to be approved as advanced therapies for use in a particular hospital or to be marketed as new drugs.

China produces the highest volume of stem cell research even before the country has adopted a clear regulatory path. A debate on how to categorize stem cell products has resulted in some hurdles in this area. (See BioWorld Today, June 22, 2014.