GC Pharma planned to enter the US market first with 5% products and later with 10% products undergoing clinical trials. However, as the approval of the 5% product was delayed, the company changed its strategy to release the 10% product, which has greater marketability, to the US market first.

GC Pharma completed phase 3 clinical trials in North America for IVIG-SN10% 'ALYGLO' in 2020 and submitted an application for product approval to the FDA in February 2021. However, in February of last year, it received a notice from the FDA to postpone the approval of the product. Due to the COVID-19 situation, a non-face-to-face evaluation was conducted in the fourth quarter of 2021, but the FDA decided t