Bio News
Final approval follows successful PMDA on-site inspection at the end of 2025 Certification establishes supply foundation for ‘Immuncell-LC’ and ‘CD5 CAR-NK’

GC Cell has obtained manufacturing certification from Japan’s Ministry of Health, Labour and Welfare, establishing a foundation for supplying 2 anticancer drugs to Japan. The certification follows the company’s successful PMDA inspection at the end of 2025 and covers ‘Immuncell-LC,’ which is marketed in South Korea, and ‘CD5 CAR-NK,’ which is in a phase 1 clinical trial. The company plans to use Japan as a base to accelerate its entry into Asian markets.

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biobookmedia@biobook.co.krBrazilian Health Regulatory Agency Approves Gazyva for a New Indication in Systemic Lupus Erythematosus
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