ArticleJournal of hematology & oncology2022
Gene and cell therapies in China: booming landscape under dual-track regulation.
Article in Journal of hematology & oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Safety profiles of CAR-T cell therapy in systematic autoimmune diseases: a systematic review and analysis.Immunologic research · 2026Pooled it
- Governing at speed? China's hard question in need of soft solutions.Molecular therapy. Nucleic acids · 2026Article
- Landscape of advanced therapy medicinal products in China and future trends.Science China. Life sciences · 2026Article
- Clinical translational research on stem cell products: prospects and challenges.Signal transduction and targeted therapy · 2026Review
- Global Pharmaceutical Regulation: Comparative Frameworks and Operations.Pharmacy (Basel, Switzerland) · 2026Review
- Beyond GCP: developing a differentiated competency framework for principal investigators in innovative drug clinical trials in China.Frontiers in medicine · 2026Article
- CAR-Based Cell and Gene Therapies: Global Clinical Landscape and Emerging Therapeutic Strategies from ClinicalTrials.gov.Biomolecules & therapeutics · 2025Review
- Advances in Gene Therapy with Oncolytic Viruses and CAR-T Cells and Therapy-Related Groups.Current issues in molecular biology · 2025Review
- International approvals of cilta-cel: a lens on CAR T cell regulation.Nature reviews. Clinical oncology · 2025Article
- The Role and Challenges of Investigator-Initiated Trials in the Cell and Gene Therapy Products Boom in Mainland China.Clinical and translational science · 2025Article
- Redefining chimeric antigen receptor T-cell (CAR-T) regulation: China's responses to address secondary cancer risks of CAR-T therapy.Journal of hematology & oncology · 2024Article
- Personalized neoantigen cancer vaccines: current progression, challenges and a bright future.Clinical and experimental medicine · 2024Review
- Review
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.