Local pharmaceutical companies are rushing to establish subsidiaries in the United States to speed up their sales activities in the world’s largest market.
According to industry sources, GC, Yuhan Corp., and Samyang Biopharmaceuticals either have established a U.S. unit or are preparing to do so.
Seeking stronger global sales power, GC set up CUREVO in Seattle, Wash., in May. CUREVO is gearing up for a U.S. clinical trial on a shingles vaccine candidate CRV-101, jointly developed by GC and Mogam Institute for Biomedical Research.
CUREVO plans to release a high-end vaccine for adults. The company expects the premium vaccine market to be at around $800 million and double the size in the next 10 years.
To develop the vaccine faster, CUREVO built a partnership with Infectious Disease Research Institute (IDRI), a U.S. think tank specializing in infectious diseases research, for sharing technologies and human resources.
Yuhan plans to set up a subsidiary in Boston in the second half. It will be the second after a San Diego unit established in March. Yuhan’s U.S. subsidiaries will focus on research and development for global trials and licensing-out deals.
Yuhan had established ImmuneOncia Therapeutics jointly with Sorrento Therapeutics to develop immune checkpoint antibodies. ImmuneOncia is planning a global clinical trial and will proceed with a selection of a partner firm or seek a licensing-out deal, depending on the development progress, Yuhan said.
Samyang Biopharmaceuticals is also to establish a U.S. unit in Boston next month to enhance networking with global firms and research institutes, and to accelerate new drug development by securing technologies or substances needed for new biopharmaceutical medicines.
Boston is considered a biotech mecca. Every year, the BIO USA, the largest biotech exhibition, is held in Boston.
Research facilities of global pharmaceutical companies such as Novartis, Pfizer, Biogen, and Takeda are concentrated in the Boston area, centering from the Massachusetts Institute of Technology.
The reason Korean drugmakers are setting up a U.S. subsidiary is to sell their drugs to the U.S. market as soon as possible. It is demanding for a Korean pharmaceutical company to enter the U.S. market because of strict regulation by the U.S. Food and Drug Administration and the relatively low recognition of Korean drugs among Americans.
Through a U.S. unit, Korean drugmakers can conduct a trial with a local partner. If a U.S. production process is in line with the U.S. regulation of cGMP (current good manufacturing practice) and the company gets a partner firm, winning a drug approval could become relatively easier.
“If a U.S. unit is available, it is easier to meet with the partner company. Also, there is an advantage in obtaining approval for a study or drug license because you can use local facilities,” an official at a drugmaker said. “As the U.S. has so many start-up companies too, the need of a local subsidiary is rising for licensing-in and licensing-out deals.”
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