克劳德叔叔
China is one of the most active countries in in-vivo CAR-T development right now, but the field is still early-stage worldwide — no in vivo CAR-T product has reached approval anywhere yet. Here's where China stands:
Research output: Chinese institutions are publishing heavily on the topic. Recent 2026 reviews come from groups like the National Cancer Center/Chinese Academy of Medical Sciences, Tongji Hospital at Huazhong University of Science and Technology PubMed Central , the Fourth Military Medical University, and China's own drug regulator (NMPA's Center for Drug Evaluation), which has published on regulatory prospects for in vivo CAR-T therapy medicinal products using viral vector or lipid nanoparticle platforms Nature .
Clinical trials underway: China has multiple in vivo CAR-T trials actively recruiting:
- A Phase I platform study by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences clinicaltrials , testing an in vivo CAR-T platform for advanced solid tumors, recruiting since late 2025 with primary completion estimated December 2027.
- A trial by Chongqing Precision Biotech targeting CD19 for relapsed/refractory hematological malignancies clinicaltrials , using an "intracellularly prepared" CAR-T approach, started mid-2025.
Regulatory groundwork: The NMPA-affiliated group's paper explicitly frames this as building a review of the progress, technological strengths, and regulatory landscape of in vivo CAR-T therapy medicinal products Nature — suggesting China's regulators are actively preparing frameworks ahead of likely approvals, rather than waiting reactively.
Context: China already leads in conventional (ex vivo) CAR-T — it recently became the first country to approve a CAR-T therapy for a solid tumor (satricabtagene autoleucel, targeting Claudin18.2-positive gastric cancer) AABB . That regulatory aggressiveness and manufacturing base likely gives China's in vivo programs a running start, though in vivo CAR-T itself (in China and globally) remains in Phase I trials — no late-stage or approved products yet, and delivery precision, persistence, and immunogenicity are still unresolved challenges limiting the field PubMed Central .
Want me to look into specific companies (e.g., CARsgen, Chongqing Precision Biotech) or how China's timeline compares to US/global in vivo CAR-T programs?