The growth of China’s biotechnology sector has been phenomenal. The Chinese government is injecting money into the industry, supporting research efforts and helping launch a new wave of labs and incubators in the country. This is a problem for the U.S. biotech industry and also affects patients with rare diseases who are waiting for treatments.
Among the experts who oppose China’s growing influence in biotechnology is John Crowley, CEO of the Biotechnology Innovation Organization (BIO), a lobbying group.
Crowley is something of a rock star in the rare disease community. His story is incredibly moving.
When Crowley and his wife were told that his two young children had Pompe disease, a fatal genetic disease, Crowley quit his job in marketing to find a cure. He formed a company in partnership with researchers who had been working on Pompe and developed a treatment that would ultimately save the lives of his children and thousands of others.
It may sound like a movie plot, and it is. Pulitzer Prize-winning journalist Geeta Anand wrote a book about Crowley’s story, which was later made into a Hollywood film, Extraordinary Measures, starring Harrison Ford and Brendan Fraser.
John Crowley, CEO of Biotechnology Innovation Agency
Biotechnology Innovation Organization
Crowley has certainly left his mark on the biotech field. He helped found two biotech companies focused on rare diseases, which were later acquired by large pharmaceutical companies. Most recently, BioMarin paid nearly $5 billion for Amicus Therapeutics in December. The company Crowley helped grow from a startup founded by five people in 2005 to a multibillion-dollar company by the time he retires in 2024. Mr. Crowley left Amicus to become CEO of BIO.
Since taking the post, he has become increasingly outspoken about China’s biotech sector, advocating for increased U.S. competitiveness.
“We need to reduce our dependence on Chinese biotechnology,” Crowley said. “If they become the dominant players, they will decide who gets what drugs and technologies.”
Crowley has seen the growth of Chinese biotech firsthand. “I remember just 10 years ago, when I was working in China, there were probably about 200 true R&D-based biotech companies in China. By our count, there are now more than 4,000,” he said.
At the same time, the Chinese government has lowered regulatory hurdles for drug companies conducting research in China, meaning they can move their developing treatments into clinical trials more quickly. This is attractive to both large pharmaceutical companies and small researchers around the world who see drug development in China as a faster and cheaper option than in the United States. A recent article in STAT covered the rise of Chinese incubator ATLATL and highlighted how the company has been able to build relationships with customers across the drug development pipeline.
For Crowley, a former naval intelligence officer, the rise of Chinese biotechnology is a threat not only to the industry he represents, but also to the millions of patients who rely on rare disease research from American universities.
“Our research, based on our nation’s great academic institutions, is a significant strategic advantage for the United States,” Crowley said. “I’ve been threatened today.”
“The biggest threat comes from the rise of China and Chinese biotechnology,” Crowley said.
“We can’t let China win in biotechnology,” he said.
Crowley is not alone in his concerns. Scott Gottlieb, former FDA commissioner and CNBC Cures advisory board member, devotes a chapter of his upcoming book, “Century of Miracles,” to the rise of Chinese biotech. In his book, Gottlieb makes the case that as the Chinese government streamlines the regulatory approval process to bring breakthrough treatments to market faster, investment in those technologies is flowing from the United States to China. He wrote:
“If this trend continues and more drug discovery moves from the United States to China, we are seeing our nation’s innovation capacity begin to decline. As capital flows to Chinese companies, American biotech hubs like Boston and San Francisco, long seedbeds of breakthrough science, could shrink. Restoring the American ecosystem will not be easy.”
The movement of capital is not theoretical. It’s happening.
A September article in Nature found that between 2020 and 2025, 11 major pharmaceutical companies made more than $150 billion in deals to gain access to assets developed in Asia, primarily China.
And data collected by Dr. Roderick Wong, a physician and founder and managing partner of life sciences investment firm RTW Investments, for another upcoming book, Innovation is the Best Medicine, shows that China tripled its share of global clinical trial starts from 2013 to 2025.
American political think tanks and lawmakers are paying close attention.
In November, the bipartisan Atlantic Council released an analysis identifying pharmaceuticals as China’s next trade weapon and likening the shift of biotech innovation to China to the offshoring of semiconductor chip manufacturing.
Spurred by concerns about corporate espionage, access to sensitive genetic data, and supply chain bottlenecks faced by the global medical supply industry after the COVID-19 pandemic, Congress passed the BioSecure Act in late 2025, later signed into law by President Donald Trump as part of a massive $901 billion defense spending bill.
The BioSecure Act prohibits biotech companies receiving federal funds from doing business with companies the U.S. designates as “biotechnology companies of concern.” Although the bill’s language is looser than previous legislation and does not ban all transactions by U.S. biotech companies with China, the law is forcing some U.S.-based companies to reconsider their relationships with China.
But for people living with rare diseases, the issue is less clear-cut. Rare diseases have no national borders. And parents looking for a life-saving treatment for their child don’t care whether it comes from the United States or China. Innovation in rare disease is a good thing. And in fields where there may only be two or three experts in the world for a particular disease, that innovation is often the result of international collaboration. Increasingly, that innovation is coming from China.
Gottlieb acknowledged that Beijing’s innovations will be beneficial for rare disease patients, but it’s a conundrum he doesn’t hesitate to answer. At least in the short term. “But it would be bad if the end result was to hollow out America’s fragile innovation sector and lose our nation’s unique engine of innovation,” Gottlieb said in the text. “The priorities of Chinese drug manufacturers may not reflect our own priorities.”
“Everything could become hollowed out as China erodes other parts of our ecosystem,” he added.
Gottlieb and Crowley said the real key to maintaining U.S. leadership in biotechnology is getting regulators to treat rare diseases that may affect only a few hundred people differently than diseases that affect more people. Rare disease researchers agree, arguing that a more streamlined FDA approval process for rare disease drugs would significantly reduce the cost of bringing new treatments to market in the United States.
David Liu, a gene-editing pioneer whose labs at Harvard University and the Broad Institute are at the forefront of genetic research, said he has called on the FDA to take a more lenient stance when evaluating new treatments for rare diseases. One example Liu pointed to is that current guidelines for cell and gene therapies require companies to demonstrate three full-scale manufacturing steps before a therapy can receive final approval.
“Gene editing treatments for rare genetic diseases typically cost $7 million for a single full-scale manufacturing run,” Liu said. “Typically, one production run can treat more patients than already exist in the entire world. That means you’re asking companies to waste an additional $14 million.”
Critics of current FDA policy argue that adopting different standards for treating rare diseases could reduce development costs, get drugs to those who need them faster, and spark a new wave of investment in the field.
“Think creatively,” Crowley said. “Why not apply the same criteria for a rare disease that involves 100 children to a treatment designed for a disease that involves millions of people?”
“We need a system that works better,” he says.
