In 2024, China’s NMPA approved 83 new drugs, FDA approved 50. China’s share of commercial clinical trials increased from 8% globally in 2013 to 30% in 2024, just behind the US at 35%. Last year, China-based Jiangsu Hengrui Pharmaceuticals surpassed AstraZeneca as the world’s leading clinical trial sponsor.
What is remarkable is that How China is winning: deregulation and capitalism. It is faster and easier to set up a clinical trial in China than in the United States. China is even experimenting with a peer-review model that I have long advocated. The Medical Tourism Pilot Zone on Hainan Island allows medical facilities to import and use any drug or device approved in the EU, US, or Japan – no separate Chinese approval is required. China uses our own regulatory decisions to get treatment to its patients faster than we do.
The main problem is that our clinical trial and drug approval process is slow and expensive. Getting a new drug to market in the US takes billions of dollars and a decade or more of clinical trials – and all of that before the company makes a single dollar. The result is drug deficiency and drug loss and learning loss. Innovation is a dynamic process. You have to build to build better.
It’s not over for the United States, though. Montana’s SB535, signed into law in May 2025, is the most important new drug regulatory initiative in my lifetime. The law authorizes investigational drugs and therapies that have cleared Phase I trials to be prescribed and marketed — bypassing the FDA’s normal approval process. It makes Montana the first state to obtain a license experimental treatment centers“one-stop shops” for hard-to-reach care.
This is a very big thing.
SB535 makes Montana a the only state in the nation where firms can quickly move from a successful Phase I trial to limited commercialization. This makes Montana a very attractive destination biopharma, biotherapeutics, and other life science companies who want to accelerate time to market while continuing through the federal FDA approval process.
Montana’s regulatory plan creates the potential for a self-financing clinical pipeline: companies using early commercial revenue to finance the path to full FDA approval. You get treatment to patients quickly, and you keep companies alive long enough to prove that their treatment works. Experimental treatments are not for everyone—these treatments are funded—there is no Medicaid or Medicare and almost no private insurance—but after conventional treatments have failed experimental treatments should be available to other patients, both for their benefit and ours.
Montana is not alone. Florida now allows non-FDA approved treatments:
A new law in Florida, CS/CS/SB 1768, allows doctors to market and administer stem cell therapies that are not yet approved by the US Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain management.
These exercises in regulatory federalism are important and not only for patients but also for geopolitical competition. I’m very happy that China is pursuing medical innovation (I predicted and applauded this in my TED talk) but I also don’t want to see America fall behind.
The Trump administration has supported him. I would like to see HHS and FDA act with companies that work under national frameworks to exercise the right to try – share data, define the boundaries of the state of the government correctly, and treat these trials as the competitive biotech infrastructure that they are.
The FDA approval process has long been considered the only legal route to market. The cost of that theory is measured in companies that never worked, innovations that never happened, and patients that died when they weren’t needed. I have spent thirty years trying to get people to see the invisible graves. That is difficult. Most remain blind. But the explosion of China’s pipeline of new drugs is evident – could this be biotech’s Sputnik moment?
A renaissance of American biotech — driven by AI, federalism, and new forms of regulation — is possible. The way forward is to double down on what makes America great: the laboratories of democracy are working, and in Montana and Florida, and so are the labs.
