[Special Stock] Y2Solution Designated RMAT by US FDA for Dry Age-related Macular Degeneration Treatment Increased

Y2 Solution is showing strong performance. This is attributed to the news that 'RPESC-RPE-4W,' a substance derived from adult retinal pigment epithelial cells (RPESC) developed by its U.S. joint venture Luxa Biotech for the treatment of dry age-related macular degeneration, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA).

As of 9:20 a.m. on the 19th, Y2 Solution is trading at 2,410 KRW, up 14.49% compared to the previous day.

According to industry sources, RMAT is one of the FDA's priority review programs for drugs. It is designated for advanced regenerative medicines aimed at treating serious or life-threatening diseases. Receiving RMAT certification provides benefits such as shortened approval review periods and regular meetings with the FDA. It is significant in that RMAT is only designated for technologies that address 'unmet medical needs.'

Dry age-related macular degeneration, which Luxa aims to treat, is a disease where retinal cells die and macular cells progressively deteriorate, causing blurred central vision. It commonly occurs in people over 50 years old. Until now, there have been treatments to slow the progression of dry age-related macular degeneration, but no treatments to improve damaged vision.

Founded in 1976, Y2 Solution has primarily produced display power supply units. It has adopted the bio sector as a new business and established a joint venture in 2019 with NSCI, a U.S. stem cell research institute. NSCI possesses transplantation technology for retinal pigment epithelial stem cells. Y2 Solution has adopted an open innovation strategy for its bio new business, focusing on early acquisition of promising core technologies and clinical progress to secure market leadership.