Chinese labs and hospitals now run most of the world’s in vivo CAR-T trials. Out of 140 candidates in animal or clinical testing, 82 percent come from China. That’s not just a big number. It’s a clear sign that the center of cell and gene therapy is moving east.
In June 2026, China approved satricabtagene autoleucel (CT041) as the first CAR-T therapy for solid tumors, marking a major regulatory milestone for the country's cell therapy market.
China’s rise did not happen by chance. The government put its weight behind the field. Hospitals have access to huge numbers of patients. Until this year, rules let researchers run investigator-initiated trials (IITs) on a large scale. John Wu’s team at Boston Consulting Group says the US and Germany led early research, but China jumped ahead in clinical trials. A Nature analysis from September 28, 2026, shows China now leads next-generation CAR-T clinical trials. The shift is real. Clinical development is moving from the West to China.
Recent results back this up. At Tongji Hospital, Huazhong University of Science and Technology in Wuhan, doctors reported in The New England Journal of Medicine that in vivo CAR-T therapy helped some of 16 patients with autoimmune diseases. They used a single intravenous dose of a lentiviral vector-based in vivo CAR-T. No lymphodepletion was needed. The trial covered four diseases: progressive multiple sclerosis, MOG antibody disease, generalized myasthenia, and idiopathic inflammatory myopathy. At the same time, a Chinese in vivo CAR-T therapy for blood cancer just got FDA approval to start clinical trials in the US. This is the first time a China-developed in vivo CAR-T-cell therapy will be tested in the United States, according to Nature.
A September 2026 review in Nature highlights that while early in vivo CAR-T research was led by the US and Germany, China has now become the global leader in next-generation CAR-T clinical trials, with a significant shift in clinical development activity.
The IIT system made this possible. Hospitals and researchers could test new tech in patients without full investigational new drug approval. This kept trial costs in China at about half the US level, says Wu’s team. But new rules came in May. Now, only top “Class 3 Grade A hospitals” can run IITs. The National Health Commission can stop or change trials over ethics. At least six in vivo CAR-T trials have already been suspended or withdrawn for not meeting the new standards.
Even with tighter rules, China’s in vivo CAR-T therapies are starting to reach other countries. The clinical trial system in China is still strong. The new rules also let hospitals offer some new treatments for rare diseases and charge fees before full approval, if trials show they work.
But big questions remain. Early results look good, but experts warn it’s too soon to know if these therapies are safe or work long-term. Ex vivo CAR-T drugs have caused serious side effects. No one knows if in vivo methods can avoid the same problems. Chen Xiaoyuan puts it plainly: “since this field is still in its early stages, substantial research is needed to establish safety and efficacy.”
The world’s biotech community is watching. China’s speed and scale are hard to match. The country has set a new pace for cell and gene therapy trials. But the real test is still ahead. Can these therapies deliver safe, lasting results for patients? Not just in China, but everywhere. For those tracking the rise of precision therapies, as reported earlier, the next phase of CAR-T innovation is happening now. China is at the center. The world is watching closely.
