Domestic pharmaceutical companies, which have been focusing on emerging countries such as Southeast Asia and South America, are stepping up efforts to advance into the US, the world's largest pharmaceutical market.
According to industry reports on March 23, Green Cross Corp. recently established a subsidiary called Curevo, which specializes in the development of premium vaccines, in Seattle. Curevo plans to conduct clinical trials in the US for a premium shingles vaccine that Green Cross Corp. is developing in Korea.
Green Cross Corp. also has set up a system in Canada that can produce blood products, its flagship items along with vaccines. It established Green Cross Biotherapeutics Inc. (GCBT), which can produce 1 million liters of blood products, in Montreal, Canada late last year. Its plant in Canada is currently undergoing pilot production and certification process with the goal of starting commercial production in 2020.
In addition, Green Cross Corp. is expecting to get an approval for immunoglobulin (IVIG-SN) from the US Food and Drug Administration (FDA).
An official from Green Cross Corp. said, "Once we get the FDA approval, the Canadian factory can start churning out the products and export them directly to the US. This is a significant move for us as we enter a blood product market worth 5 trillion won a year. We will try to respond quickly to local demand.”
Yuhan Corp. established Yuhan USA in San Diego, last March. Yuhan USA is a venture capital company that invests in bio-ventures with promising technologies instead of conducting research and development on its own. It is intended to use its expertise in locating promising companies and products. Yuhan USA is planning to open another office in Boston. An official from Yuhan said, “San Diego and Boston have well-established bio-ecosystems as they are thought to be the representative bioclusters in the US. We will expand the scope of open innovation beyond Korea, to other countries including the US.”
There are also examples of exporting high-quality medicines to the US. Huons signed a contract with a US pharmaceutical company earlier this month to supply lidocaine, local anesthetic, worth 89 billion won over 20 years. On May 10, the first shipment of 300,000 ampules was made. This is the first case of exporting domestic injections to the US. An official from Huons said, "We have been able to enter the local market quickly, as generic products have a simpler approval process compared with new medicines. From the establishment of our building, we tried to comply with the FDA drug manufacturing and quality control standards (cGMP). Apparently, our strategy worked well.”
Daewoong Pharmaceutical is preparing to enter the US market with Nabota, its botulinum toxin (botox) product. Recently, it gained an approval from FDA for the production facility dedicated to Nabota. An official from Daewoong Pharmaceutical said, "In order to export Nabota, we have to get both product approval and facility approval. The facility has been approved and the product approval is in progress. We are going to apply for the resumption of product approval and it will take about 6 months.”
In addition, Hanmi Pharmaceutical is conducting clinical tests with a US partner on a variety of new medicines, including diabetes treatments for which it exported its technology and nonalcoholic fatty liver disease treatments. In particular, it is preparing to apply for FDA approval for Rolontis, a treatment for neutropenia, after completing a clinical trial with breast cancer patients. A Hanmi Pharmaceutical official said, "Our competitiveness is being recognized as we have improved our patient convenience by applying our own unique technology for lasting effects. We are preparing various clinical trials to expand the usage of our products."
Domestic pharmaceutical companies are constantly seeking to enter the US market despite its high entry barriers. It is because the US is the world's largest pharmaceutical market but its regulation is the toughest. Therefore, the fact that the companies have entered the US market is interpreted that they have secured global competitiveness
According to IQVIA, a pharmaceutical market research firm, the US pharmaceutical market is worth US$433.5 billion (about 464 trillion won) in 2016, accounting for 40 percent of the global market (US$1 trillion, about 1178 trillion won). The US FDA regulations are considered to be the most advanced along with the European Medicines Agency (EMA) regulation. Lee Jae-kook, managing director of the Korean Pharmaceutical Biotechnology Association, said, "Success in the US is a standard when we enter other countries. As the quality of domestic medicine and R&D capabilities have improved, entry into the US is not just a dream.”