Sinophex's stock price is on the rise. The news that it has obtained the first GMP certification related to hemodialysis machines in Korea appears to be influencing the stock price.
As of 9:55 AM on the 21st, Sinophex was trading at 3,660 KRW, up 625 KRW (20.59%) compared to the previous trading day.
On the same day, Sinophex announced that its Banggyo plant received GMP (Good Manufacturing Practice for medical devices) certification from the Ministry of Food and Drug Safety for ▲hemodialysis machines ▲CRRT devices ▲mobile artificial kidney production.
Since September 2020, Sinophex has been participating in a national project (Research and Development Project for Localization of Continuous Renal Replacement Therapy Medical Devices) with Seoul National University Hospital to localize hemodialysis machines, which have been entirely dependent on imports, continuously investing in technology development. The 'Sinophex Banggyo plant,' the main production base for hemodialysis machines, achieved the distinction of being the first in Korea to obtain GMP certification related to hemodialysis machines.
The Sinophex Banggyo plant established facilities capable of producing 2 million hemodialysis machines annually in cooperation with Alpha Plan, a global company related to hemodialysis machines based in Germany. It has secured exclusive monopoly rights for the domestic market until 2025. Sinophex has already developed ▲11 types of hemodialysis machines ▲CRRT devices ▲mobile artificial kidneys ▲CRRT blood circuit products and is conducting pre-marketing targeting domestic and international nephrology societies and hospitals. Following the GMP certification, full-scale sales are planned once product approval is completed by the end of this year.
Dr. Jin-tae Lee, head of Sinophex's Biomedical Business Division, said, "This is the first GMP certification for hemodialysis and artificial kidney production facilities in Korea," adding, "The synergy of Sinophex's membrane and filter technology, accumulated over 38 years, played a significant role."
The hemodialysis machines developed by Sinophex are compatible with the hemodialysis devices currently imported and used domestically. The domestic market for hemodialysis-related consumables, including hemodialysis machines, is expected to reach 1.8 trillion KRW this year. Although the number of patients requiring hemodialysis is rapidly increasing due to aftereffects of COVID-19 and other factors, the market has so far been entirely dependent on imports.
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