If the U.S. wants to hold on to its title as the world’s top biotech innovator, it might want to take a page out of China’s book, a pioneer in CAR-T cell therapy said on Thursday.
“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.,” Michel Sadelain, director of the Columbia Initiative in Cell Engineering and Therapy, said at the STAT Breakthrough Summit East. “They’re 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’re still thinking about how to find money to perform a trial.”
One of the factors propelling China’s current cell and gene therapy boom is the country’s dual-track regulatory system, which allows for experimental therapies to be tested for the first time in humans through “investigator initiated trials,” or IITs. These are studies typically run by clinical researchers in hospitals that can be started quickly and with less red tape than a typical drug trial, accelerating initial insights into therapeutic efficacy.
Since 2018, IITs for cell and gene therapy products have grown rapidly across mainland China, enrolling over 30,000 participants, twice the number in typical drug trials overseen by a national regulatory body, according to a 2025 analysis.
IITs represent an incredible advantage in terms of de-risking new experimental therapies, Sadelain said, one that he hopes the U.S. finds a way to replicate.
“I do think we should adapt our system and restore some of our competitiveness with China,” he said. “I think that academic centers in the U.S., certainly in the world of cell therapy, are very capable of manufacturing these products that are born in academia. And I hope that we’ll see an evolution here very soon to allow that.”
The remarks point to increasing anxiety about the possibility of China overtaking America’s decades-long status as the global leader in drug discovery, development, and approvals. Fueled by nationalist ambitions, massive government investments, and permissive regulatory structures, China’s biotechnology sector has undergone an explosive expansion in recent years. Since 2018, China’s output in terms of new drug discovery has tripled, while output by American sources has remained comparatively flat, according to one analysis by researchers at Stony Brook University.
Since the end of World War II, the U.S. has dominated the R&D pipeline. In addition to providing Americans with earlier access to breakthrough therapies, this leadership position has granted the U.S. control over the global pharmaceutical market and the power to shape international regulatory norms and supply chains. But a trend of declining federal support for biomedical research over the past few decades — accelerated by the second Trump administration’s shattering of the government’s research partnership with academia and cuts to the federal science workforce — now threatens that position of privilege.
A new forecast released Thursday by science policy researchers at the University of California, San Diego predicts that, in what would be a watershed moment, China’s public spending on research is likely to surpass that of the United States in the next two to three years.
While these trends were especially alarming to academics like Sadelain, pharma R&D executives struck a more optimistic tone.
“I’m trying to not think about it as a threat, more as an opportunity,” Jane Grogan, head of research at Biogen, said during an earlier session on Thursday. “We’re out in China, we’re talking to VCs, academics, startups as well to see how can we actually partner with them to develop quickly and agilely drugs,” she added.
While more resources and opportunities going to China or other countries can be a challenge for American institutions, “that’s a very, I think, U.S.-centric perspective,” said Robert Plenge, chief research officer of Bristol Myers Squibb. He advised keeping the focus on patients and figuring out ways to deliver the best possible medicines amid evolving political and financial realities. He and others on the panel stressed that patients don’t care where a cure comes from, as long as it works.
“If you’re 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,” Plenge said.
Stelios Papadopoulos, board chair of Exelixis and a longtime biotech leader, also downplayed the notion of China as a threat. “There’s a lot of smart people there and smart people are good people, so I’m not worried,” he said.
