The Evolving Cell and Gene Therapy (CGT) Sector in China

In 2003, State Food and Drug Administration (SFDA), the Chinese national regulatory authority, upon its Institutional reform, drafted a guideline for human cell therapy, which was finally released in 2008 (1).The guidance discussed Chemistry, Manufacturing, and Controls (CMC), non-clinical, and clinical aspects of cell therapy. It pointed out the challenges of cell manufacturing, inspection of cells, and quality control of cells. It also outlined the requirement for sponsors to follow GMP, GLP, and GCP standards. However, despite the guidance, the majority of hospital-employed investigators still considered themselves not to be companies, which would mean that they were under no obligation to receive approval from SFDA for administering cell therapies as part of their medical practice. In 2013, a survey was carried out by the China Medicinal Biotechnology Association (CMBA), which revealed that out of a sample of 150 hospitals in Beijing, Shanghai and other major cities, all 150 of the hospitals had “cytokine-induced killer cells” (CIK)* programs. Among them, 88 hospitals also provided options for “dendritic cell-cytokine-induced killer cell” (DC-CIK)** therapy. Altogether, 54,094 patients received hospital-based CIK and DC-CIK treatments in 2013, with the cost per course of treatment ranging from CNY 5,500 to CNY 54,000.

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