The expansion of China’s biotechnology sector has been staggering. Beijing is pumping cash into the business, backing analysis efforts and serving to launch a brand new wave of labs and incubators within the nation. That is an issue for the U.S. biotech business and likewise impacts uncommon illness sufferers who’re ready for a remedy.
Among the many consultants talking out towards China’s rising affect within the biotech sector is John Crowley, CEO of the lobbying group Biotechnology Innovation Group, or BIO.
Crowley is one thing of a rock star within the uncommon illness neighborhood. His story is as unimaginable as it’s inspiring.
When Crowley and his spouse have been instructed his two younger youngsters had Pompe illness, a deadly genetic dysfunction, Crowley left his job in advertising to attempt to discover a remedy. He partnered with a researcher who was engaged on Pompe, and began an organization that ultimately developed a remedy to save lots of the lives of his youngsters and hundreds of others.
If it sounds just like the plot of a film, it’s. Pulitzer Prize-winning journalist Geeta Anand wrote a e-book about Crowley’s story, which later grew to become the Hollywood movie “Extraordinary Measures,” starring Harrison Ford and Brendan Fraser.
John Crowley, CEO of Biotechnology Innovation Group
Biotechnology Innovation Group
Crowley has definitely made his mark within the biotech house. He helped construct two biotech corporations targeted on uncommon illnesses that have been later acquired by bigger prescription drugs. Most lately, in December, BioMarin paid almost $5 billion for Amicus Therapeutics, an organization Crowley helped develop from a five-person startup in 2005 to a multibillion-dollar firm when he left in 2024. Crowley left Amicus to change into the CEO of BIO.
Since getting into that submit, he has change into more and more outspoken about China’s biotech sector, advocating for the U.S. to change into extra aggressive.
“We have to cut back the reliance on Chinese language biotechs,” Crowley mentioned. “As soon as they’re the dominant participant, then they may resolve who will get what medicines and applied sciences.”
Crowley has seen the expansion of China’s biotech firsthand. “I’m going again to even simply 10 years in the past, perhaps, working in China. There have been perhaps a pair hundred true R&D biotech corporations in China. By our depend, there’s over 4,000 in the present day,” he mentioned.
On the identical time, Beijing is lowering the regulatory hurdles for drugmakers doing analysis in China, that means the remedies they’re engaged on can get into medical trials extra rapidly. That is enticing to each main drug producers and smaller researchers from world wide, who see growing medication in China as a quicker and cheaper choice than in the US. A current article in STAT profiled the rise of 1 Chinese language incubator, ATLATL, highlighting the way it’s been capable of develop relationships with shoppers spanning the whole drug growth pipeline.
To Crowley, who’s a former naval intelligence officer, China’s rise in biotech is a menace not simply to the business he represents, however to the thousands and thousands of sufferers who depend on the uncommon illness analysis that comes out of American universities.
“Our analysis grounded in our nice tutorial establishments [is] a exceptional strategic benefit for the US,” Crowley mentioned. “It is threatened in the present day.”
“The best menace comes from China and the rise of Chinese language biotechnology,” Crowley mentioned.
“We won’t let China win in biotech,” he mentioned.
Crowley is just not alone in his issues. Former FDA Commissioner Scott Gottlieb, a member of the CNBC Cures Advisory Board, devotes a chapter in his forthcoming e-book, “The Miracle Century,” to China’s rise in biotech. Within the e-book, Gottlieb lays out the case that as Beijing has simplified the regulatory approval course of so breakthrough medical remedies get to market sooner, funding in these applied sciences has flowed from the U.S. to China. He wrote:
“If this drift continues and extra drug discovery migrates from the U.S. to China, we may see our capability for innovation start to erode. As capital flows towards Chinese language companies, U.S. biotechnology hubs like Boston and San Francisco, lengthy the seedbeds of breakthrough science, might shrink. Restoring that American ecosystem can be something however straightforward.”
The shift in capital is just not theoretical. It is taking place.
A September article revealed in Nature discovered that from 2020-2025, 11 of the most important pharma gamers dedicated greater than $150 billion in offers for entry to property developed in Asia, primarily in China.
And knowledge gathered for one more forthcoming e-book, “Innovation is the Finest Drugs,” by Dr. Roderick Wong, a doctor and the founder and managing accomplice of life sciences funding agency RTW Investments, reveals that from 2013-2025, China tripled its share of world medical trial initiations.
Political suppose tanks and lawmakers within the U.S. have taken discover.
In November, the nonpartisan Atlantic Council revealed an evaluation that recognized prescription drugs as China’s subsequent commerce weapon, likening the shift in biotech innovation to China to the offshoring of semiconductor chip manufacturing.
Spurred on by issues about company espionage, entry to delicate genetic knowledge, and reminiscences of the provision chain bottlenecks the worldwide medical provide business confronted after the Covid pandemic, Congress in late 2025 handed the Biosecure Act, which President Donald Trump later signed into regulation as a part of the large $901 billion protection spending invoice.
The Biosecure Act prohibits biotech corporations that obtain federal funds from doing enterprise with corporations that the U.S. designates as “biotech corporations of concern.” Whereas it will not prohibit all enterprise U.S. biotech corporations do with China, and language within the regulation was softened from an earlier model of the invoice, the regulation is forcing some companies based mostly within the U.S. to reexamine their ties to China.
However for folks dwelling with a uncommon illness, the problem is not so clear-cut. Uncommon illnesses do not respect borders. And fogeys in search of a lifesaving remedy for his or her baby do not care if it comes from the U.S. or China. Innovation within the uncommon illness house is an efficient factor. And in a subject the place there may be solely two or three consultants on the planet on any given illness, that innovation is usually the results of worldwide collaboration. Increasingly more continuously that innovation is coming from China.
It is a conundrum that is not misplaced on Gottlieb, who acknowledged the innovation from Beijing is nice for uncommon illness sufferers. At the least within the brief time period. “If the top outcome, although, is that the delicate U.S. innovation sector will get hollowed out and we lose our personal engine of innovation, that is unhealthy,” Gottlieb mentioned in a textual content. “The precedence targets of Chinese language drug makers might not mirror our precedence targets.”
“As China erodes different elements of our ecosystem, it may hole out every little thing,” he added.
Each Gottlieb and Crowley mentioned the true key to sustaining U.S. management in biotech is getting regulators to deal with uncommon illnesses, which could have an effect on just a few hundred folks, in another way from these with bigger affected person populations. Uncommon illness researchers agree, arguing {that a} extra streamlined approval course of for uncommon illness remedies from the FDA would dramatically deliver down the price of bringing a brand new remedy to market within the U.S.
David Liu, a pioneer in gene enhancing whose lab at Harvard College and the Broad Institute is on the chopping fringe of genetic analysis, mentioned he is requested the FDA to take a extra lenient stance when evaluating new remedies for uncommon illnesses. One instance Liu pointed to: present tips for cell and gene therapies that require an organization demonstrates three full-scale manufacturing runs earlier than a remedy can get remaining approval.
“One full-scale manufacturing run usually prices $7 million for uncommon genetic illness gene enhancing remedies,” Liu mentioned. “One manufacturing run can usually already deal with extra sufferers than exist in the entire world. So that you’re simply asking corporations to throw away an additional $14 million.”
Critics of present FDA insurance policies argue that utilizing a special set of requirements for uncommon illness remedies would deliver down growth prices and assist the medication get to the individuals who want them extra rapidly, and that it may spur a brand new wave of funding within the house.
“Let’s suppose creatively,” Crowley mentioned. “Do not apply the identical requirements for a uncommon illness with 100 youngsters to a remedy designed for a illness with thousands and thousands of individuals.”
“We want a system that works higher,” he mentioned.
