GCell Obtains Japan's "Specified Cell-Processed Product Manufacturing Certification"

GCell announced on May 6 that it has officially obtained final certification for the manufacture of specified cell-processed products (CPC) from the Ministry of Health, Labour and Welfare of Japan.

GC Cell corporate logo image. GC Cell

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This certification was officially granted after passing an on-site inspection by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan at the end of last year.

Japan's specified cell-processed products system strictly manages manufacturing facilities and processes in the fields of regenerative medicine and cell therapy. Overseas manufacturing facilities are also subject to certification under the same standards. With this approval, GCell has met Japan's stringent regulatory requirements and demonstrated its global-level competitiveness in manufacturing and quality.

Through this certification, GCell has established a legal foundation to supply 'Immuncell-LC Injection', which is approved and marketed in Korea, as well as the cell and gene therapy product 'CD5 CAR-NK (GCC2005)', which is currently undergoing Phase 1 clinical trials in Korea, to medical institutions in Japan. This opens the door for entry into the Japanese market at both the manufacturing facility and platform level. GCell plans to expand cooperation with local medical institutions and partners, and to accelerate its strategy for entering the broader Asian market with Japan as its base.

Sungyong Won, CEO of GCell, stated, "Obtaining the specified cell-processed product manufacturing certification from the Japanese Ministry of Health, Labour and Welfare is official recognition that GCell’s manufacturing and quality systems meet global regulatory standards," and added, "We will actively pursue clinical and commercialization strategies to expand access to cell therapies in the global market and provide new treatment options for patients."

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