GC Cell (GC Cell) announced on the 6th that it has obtained final certification for its Cell Processing Center (CPC) for the manufacture of specified cell products from Japan’s Ministry of Health, Labour and Welfare (MHLW). This certification was officially granted following an on-site inspection by the Pharmaceuticals and Medical Devices Agency (PMDA) at the end of 2025.

With this certification, GC Cell has secured the legal basis to supply “Immuncell-LC Inj.,” which is approved and marketed in Korea, and the cell and gene therapy product “CD5 CAR-NK (GCC2005),” currently in Phase 1 clinical trials, to medical institutions in Japan. As the certification is granted at the manufacturing-facility level, it is being assessed as opening up the possibility for additional pipeline entries into the Japanese market in the future.

The specified cell product system is a regulatory framework in Japan’s regenerative medicine and cell therapy sectors that strictly oversees manufacturing facilities and the entire production process, with the same standards applied to overseas companies. Through this certification, GC Cell has received official recognition that its manufacturing facilities and quality control systems comply with Japanese regulatory standards.

The industry views this certification as more than a simple approval, regarding it as a starting point that could lead to clinical research, collaboration with medical institutions, and commercialization discussions within Japan. Japan is particularly known as a region where regulations and the market for regenerative medicine are growing simultaneously. Analysts note that whether a company enters the market at an early stage could affect its future market competitiveness.

GC Cell plans to use this certification as an opportunity to expand collaboration with local medical institutions and partners and to accelerate its strategy for entering the broader Asian market with Japan as a hub. Based on this, the company also intends to expand its CDMO (Contract Development and Manufacturing Organization) business alongside the development of its own pipeline. Its strategy is to leverage globally competitive manufacturing quality to broaden collaboration opportunities with domestic and overseas companies.

Won Sung-yong, CEO of GC Cell, said, “This certification demonstrates that GC Cell’s manufacturing and quality systems meet global regulatory standards,” adding, “We will continue to work to expand access to cell therapies and to advance our clinical and commercialization strategies.”

The cell therapy industry is considered a sector where, due to its stringent regulatory requirements, volatility may arise during clinical development and commercialization. Some analysts also note that it will be necessary to monitor developments going forward to assess the actual business performance following entry into the Japanese market.

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