30,000 Patients Later: How China's Regulatory Shortcut Is Outpacing U.S. Science

CAR-T was born in New York. Today, the most coveted data in cell therapy is coming from Chinese hospitals.

That shift — from American scientific primacy to a more complex reality where China runs more CAR-T trials than the United States and produces clinical data faster — is the biotech story of the moment. At STAT Breakthrough Summit East this week, Michel Sadelain, director of the Columbia Initiative in Cell Engineering and Therapy, put it plainly: CAR-T cells were born in the U.S., actually here in New York City, but today there are more CAR-T cell trials in China than in the U.S. They are variants on things that often have been published here before, but boom, the trial starts there and then they have patient data, while here we are still thinking about how to find money to perform a trial.

What is driving the gap is less about scientific talent and more about regulatory architecture. China operates a dual-track system for early clinical work: experimental therapies can enter first-in-human testing through investigator-initiated trials, or IITs — studies run by hospital-based researchers that require only local ethics approval rather than national regulator sign-off. Since 2018, cell and gene therapy IITs in China have enrolled over 30,000 participants, roughly double the number in trials overseen by the national regulatory body, according to a 2025 analysis. The number of Chinese IITs for cell and gene therapies grew elevenfold between 2015 and early 2024, according to an analysis by Beijing-based Changping Laboratory, totaling more than 1,000 studies.

The speed advantage is concrete. When Belgian startup EssoBiotec wanted early clinical data on its in-vivo CAR-T therapy for multiple myeloma, it worked with a Chinese partner to run an endpoint news — a study run by hospital-based researchers that required only local ethics approval rather than national regulator sign-off. It treated its first patient in November. Months later, AstraZeneca agreed to acquire the company for $425 million upfront. We gained probably two years, EssoBiotec CEO JP Latere said of the Chinese IIT pathway.

That acquisition is a useful data point in a debate that tends toward abstraction. Sadelain's call to adapt our system reflects real competitive anxiety among academic researchers — his prestige depends on being first. The pharmaceutical executives on the same panel took a more transactional view. Jane Grogan, head of research at Biogen, said she tries not to think about it as a threat, more as an opportunity. Biogen is in China, talking to VCs, academics, and startups — looking for partnerships. Robert Plenge, chief research officer of Bristol Myers Squibb, put it this way: If you are a patient wanting to get the best possible medicine as quickly as possible, I think having innovation across the globe is the best possible outcome. Stelios Papadopoulos, board chair of Exelixis, was the most sanguine: There is a lot of smart people there and smart people are good people, so I am not worried.

The divergence in tone tracks with incentive structures. Academic scientists watch their discoveries get replicated and trialed in China before they can fund their own studies — that is a genuine wound to prestige and competitiveness. Pharma, by contrast, can simply license whatever works wherever it works. For a large company, a Chinese-origin cell therapy that reaches patients first is still a therapy they can co-commercialize.

But there is a structural question underneath Plenge's patient-first framing that nobody on the panel fully addressed: leadership in biopharma may be a positional good. The U.S. did not build its research dominance through good intentions — it built it through decades of sustained public investment that created institutions, norms, supply chains, and talent pipelines that remain deeply embedded. If China overtakes the U.S. in clinical trial data, it does not just mean faster drug development — it means Chinese institutions increasingly shape which therapies get developed, which regulatory standards become global norms, and which supply chains become indispensable. These are not just scientific outcomes. They are commercial and geopolitical ones.

The trends in R&D investment make the competitive trajectory harder to dispute. A forecast from researchers at the University of California, San Diego Frontiers in Science and Innovation Policy — produced for Nature Index and released this week — projects China will surpass U.S. public spending on research within two to three years. The earliest likely crossover is 2027; the central estimate is 2028. China government R&D spending rose 90 percent over the decade to 2023, reaching $133 billion in purchasing-power-adjusted terms, while U.S. government R&D spending rose just 12 percent over the same period, to $155 billion. China already produces double the U.S. output in the natural science and health science journals tracked by Nature Index, a measure of research quality and volume that tends to precede commercial dominance by a decade or more.

These numbers are projections, not certainties — the UCSD analysis assumes U.S. research spending remains roughly flat, incorporating a recent slowdown in Chinese spending that the researchers attribute partly to pandemic-era conservatism and a property-sector crisis. And as Yutao Sun, an innovation policy specialist at Dalian University of Technology, noted, purchasing-power-adjusted comparisons may overstate China's position, since scientific equipment and journal access are often priced on international markets. But the direction is clear.

The Trump administration's recent disruption of the federal science apparatus — cuts to the research workforce, the severing of government-academia partnerships — lands in the middle of this trajectory. Whatever one's view of the appropriate size of government, the finding that Chinese drug discovery output has tripled since 2018 while American output stayed flat is at least partly a function of deliberate choices about public investment.

For biotech investors and founders, the implications cut both ways. A China that produces clinical data faster is a China that Western pharma will pay to access — which is why companies like Stylus Medicine are actively considering Chinese IITs for their first-in-human trials, and why AstraZeneca paid $425 million for an asset that used one. That is an opportunity. It is also a dependency. The question is whether the U.S. responds by adapting its own regulatory pathways — as Sadelain hopes — or whether it continues to watch from the sidelines while the trial data accumulates elsewhere.