Vita：中国细胞与基因治疗（CGT）领域的研究者发起试验（IIT）

TL;DR - An expert analysis argues that China’s investigator-initiated trial pathway accelerates early clinical validation of cell and gene therapies while new national rules strengthen oversight and commercialization routes.

• CGT-IITs generate small-cohort safety and proof-of-concept data before costly registration trials.
• China’s framework combines institutional scientific and ethical review, national filing, and long-term data retention.
• The 2026 regulations create dual drug-registration and medical-technology pathways, including approved clinical charging.
• Remaining challenges include inconsistent review quality, data reliability, informed consent, patient access, and long-term monitoring.