Gene and cell therapies in China: booming landscape under dual-track regulation

The booming of gene and cell therapy (GCT) worldwide in recent years has been observed, especially in the field of cancers. In order to provide the comprehensive GCT landscape in China with a focus on differential development pathways under the current dual-track regulation mode, we analyzed 953 cli...

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Bibliographic Details
Published in:Journal of hematology and oncology 2022-10, Vol.15 (1), p.1-139, Article 139
Main Authors: Yin, Chen, Gao, Jianchao, Li, Guanqiao, Hu, Hongxi, Zhou, Liyun, Lu, Shuang, Chen, Xiaoyuan
Format: Article
Language:English
Subjects:
Antigens
Biological products
Cancer
Cell therapy
Clinical development
Clinical trials
Correspondence
Dual-track regulation
FDA approval
Forecasts and trends
GCT
Genes
Hematology
Lymphocytes
Medical colleges
Oncology
R&D
Research & development
Somatic cells
Stem cells
T cell receptors
Transplantation
Trends
Tumors
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Summary:The booming of gene and cell therapy (GCT) worldwide in recent years has been observed, especially in the field of cancers. In order to provide the comprehensive GCT landscape in China with a focus on differential development pathways under the current dual-track regulation mode, we analyzed 953 clinical trials initiated by March 2021 including Investigational New Drugs (IND) registered trials and investigator-initiated trials (IITs). We classified GCT products into three categories and analyzed the clinical development by phases and regulation tracks, disease areas, indications, and targets. We found that CAR-T therapies from ex vivo category and stem and somatic cells from non-gene category are two most studied therapy types and GCT mostly focused on cancers. The number of IITs far exceeded IND-registered trials except for in vivo category. After 2017, when the cell therapy guideline issued, products of all categories boomed, especially the ex vivo categories. These data showed that current dual regulation tracks in China complemented each other and together facilitated the GCT development, especially after 2017. More consistent technical standards and risk-based regulation will help bring more GCT products to patients.
ISSN:1756-8722
1756-8722
DOI:10.1186/s13045-022-01354-9