In June 2026, China’s National Medical Products Administration cleared satricabtagene autoleucel (satri-cel), CARsgen’s Claudin18.2 CAR-T, for advanced gastric cancer. It became the world’s first CAR-T cell therapy approved for a solid tumour. The science is genuinely impressive. But the geography is the story.

Satri-cel is not a Chinese drug that sidestepped Western scrutiny. The FDA granted it Regenerative Medicine Advanced Therapy (RMAT) designation in January 2022 and Orphan Drug status in September 2020. The EMA added PRIME and orphan designation as well. Three of the world’s most demanding regulators raised their hands and signalled: we want to see this at the finish line. And yet the drug’s pivotal Phase II trial, CT041-ST-01, ran entirely in China. It was published in The Lancet and presented at ASCO 2025. Patients in China received it first, not patients in the United States or Europe. 

A therapy carrying the most coveted expedited designations the FDA offers chose to run its registration-enabling trial somewhere else. 

China has caught up on clinical trial volume 

The conventional framing in Western biotech is that Chinese trials are a cost-saving shortcut, not a scientific strategy. That framing has become outdated.

In 2024, China registered more clinical drug trials than the United States for the first time, roughly 7,100 to 6,000 by the WHO’s International Clinical Trials Registry Platform, having already overtaken the US in Phase I trial share in 2021. This did not happen by accident. China spent nearly a decade reforming its regulatory infrastructure, recognising foreign trial data, accelerating review timelines, and expanding its network of clinical sites. The NMPA today operates with a rigor that would have been unrecognisable ten years ago. 

Satri-cel may be the first headline consequence of that structural shift. It is unlikely to be the last. 

The economics are difficult to argue with 

The cost differential between running trials in China and the United States is not a rounding error. A full Phase III oncology study costs roughly $15 to $20 million in China versus $40 to $50 million in the US. At the per-patient level, direct costs for a Phase III lung cancer trial sit near $25,000 in China against $69,000 in the US. Recruitment moves two to three times faster, drawing on large treatment-naive patient pools: China diagnoses approximately 780,000 newly eligible immuno-oncology patients per year compared to 234,000 in the US. 

For a capital-constrained company, and most biotechs are, lower cost is not a margin improvement. It is the difference between a trial that gets funded and one that does not. US early-stage life science funding has tightened considerably since its 2021 peak, and a 60% reduction in trial cost combined with a two to three times improvement in enrolment speed is not a preference in that environment. It is survival arithmetic.

Western pharma has drawn the same conclusion from the buy side. Rather than building pipelines in-house, major pharmaceutical firms have increasingly acquired de-risked clinical and preclinical assets out of Chinese biotechs. Cross-border out-licensing from Greater China reached a record $137.7 billion in 2025, nearly tenfold higher than 2021 and approximately one-third of all global licensing spend for the year. 

How the FDA has responded to China-only trial data 

The sintilimab case is the clearest illustration of where this divergence creates friction. 

In February 2022, the FDA’s Oncologic Drugs Advisory Committee voted 14 to one to require an additional study before a regulatory decision could be made on sintilimab, the PD-1 inhibitor co-developed by Innovent Biologics and Eli Lilly. The FDA issued a Complete Response Letter in March 2022. The committee’s concern was not that the drug failed to meet its endpoints: the ORIENT-11 study met its primary endpoint of progression-free survival. The concern was structural. The pivotal trial enrolled only Chinese patients, used a platinum-based comparator regimen that no longer reflected US standard of care, and did not use overall survival as its primary endpoint. The advisory committee concluded that it could not generalise the data to the US population. 

Several months later, the FDA issued a Complete Response Letter to HUTCHMED for surufatinib, a multikinase inhibitor for neuroendocrine tumours. HUTCHMED had submitted two positive Phase III trials conducted in China plus a smaller US bridging study. The FDA concluded that a full multiregional trial would be required. 

These decisions reflect defensible regulatory logic. Single-country data may not generalise across patient populations, comparator arms should reflect current clinical practice, and the FDA has a legitimate mandate to ensure that approval decisions are grounded in evidence applicable to American patients. What transforms this into an investment variable is the direction of legislative travel. On 29 April 2026, the House Appropriations Committee advanced FY2027 report language that would bar the FDA from accepting, reviewing, or considering clinical trial data generated in China, Russia, Iran, or North Korea in support of any Investigational New Drug application. The language appears in the accompanying committee report rather than the bill text itself, meaning it would not carry the force of law even if the broader bill were enacted. Legal analysts consider its survival through the full legislative cycle unlikely. But it is consistent with a pattern of biosecurity legislation that has been hardening for several years, and its direction is not ambiguous. 

What sintilimab’s rejection cost American patients 

On the eve of the sintilimab advisory committee meeting in February 2022, Lilly announced that it would price the drug at approximately 40% below entrenched PD-1 competitors such as Keytruda, whose US annual list price at the time approached $175,000. The same molecule was available in China for a pre-reimbursement annual cost of roughly $14,680. The FDA is legally prohibited from considering drug prices in its approval decisions, and it did not. But the downstream effect is real.

Fewer China-originated entrants means fewer low-cost challengers in drug classes where US list prices have proven highly resistant to competitive pressure, a resistance that is structurally reinforced by how PBM rebates and insurance reimbursement are constructed. The lone dissenting vote on the sintilimab advisory committee came from an oncologist who backed approval specifically on cost-of-care grounds, noting that access to competitively priced alternatives could drive down systemic treatment costs. That argument did not prevail. But it identified the stakes clearly.

The cumulative logic is uncomfortable: systematic exclusion of Chinese-developed drugs removes the category of competitor most likely to exert meaningful pricing pressure in high-cost drug classes. Patients bear that cost, one renewal cycle at a time. 

Why banning Chinese data affects western companies most 

There is an irony at the centre of the proposed data ban that tends to get lost in the geopolitical framing: the companies with the most exposure to it are American. 

Big pharma is navigating a substantial patent cliff. When branded drugs lose exclusivity, generics typically displace the large majority of revenue in the affected class. The Chinese-originated pipelines that Western firms have been acquiring at accelerating pace, the same $137.7 billion worth of deals in 2025, are precisely how they intend to replace that protected revenue. A policy that bars the FDA from accepting Chinese clinical data at the IND stage would not simply slow Chinese biotech. It would force the Western companies that purchased those assets to re-run trials they believed were complete, adding years and hundreds of millions in cost at exactly the moment they can least afford it. A rule framed as protecting the US pharmaceutical market would land first on the US companies that have come to depend on Chinese-originated pipelines to sustain it.

About the author 

Boyang Wang is the founder of Immortal Dragons, a longevity fund based in Singapore. He holds a Bachelor’s degree in Computer Science from the National University of Singapore and attended Yale University for graduate studies in Computer Science before leaving to pursue entrepreneurship. Prior to founding Immortal Dragons, he established several technology startups. He also currently serves as a senior venture fellow at Healthspan Capital.