China Emerging as Worried Leader in Anti-Cancer and Other Bio
Tech Pharma
Clinical trials in China are getting attention
at an international oncology gathering in Chicago. China’s surging biotechnology
industry is fueling alarm that U.S. dominance in the field
is waning.
o For the first time, a clinical
trial conducted entirely in China has been selected as one of the headline presentations
at the annual meeting of the American Society of Clinical
Oncology (ASCO), highlighting China's growing
influence in cancer drug development.
2.
Rapid Rise of China’s Biotech Sector
o China has transformed from
a minor player into a major biotechnology hub, producing increasing numbers of patents,
clinical trials, research papers, and innovative medicines.
3.
Growing U.S. Concerns
o American officials, researchers,
and biotech firms fear losing leadership in pharmaceutical innovation, with some
warning that China is becoming a serious competitor to the U.S. biotech industry.
4.
Questions Over Applicability of Chinese Trial Data
o Experts debate whether results
from trials conducted solely in Chinese patients can be reliably applied to American
populations due to genetic, lifestyle, and treatment differences.
5.
Global Pharma Increasingly Turning to China
o Major pharmaceutical companies
are licensing promising Chinese-developed drugs because of lower costs, faster development
timelines, and fewer regulatory barriers in China.
6.
Ivonescimab Takes Center Stage
o The lung cancer drug Ivonescimab, developed by Akeso Biopharma
and licensed by Summit Therapeutics, is the focus of the headline ASCO presentation after showing
promising results in Chinese patients.
7.
Strategic and National Security Concerns
o Critics worry that increasing
dependence on Chinese-developed medicines could create supply-chain vulnerabilities
and reduce U.S. control over critical healthcare technologies.
8.
Political Attention in Washington
o Both Republican and Democratic
policymakers have raised concerns about U.S. reliance on China for pharmaceuticals,
with some proposing restrictions on Chinese clinical data and biotech partnerships.
9.
Regulatory Attitudes Are Evolving
o Historically, the U.S. Food and Drug Administration was reluctant to approve drugs based solely on Chinese data,
but regulators now acknowledge that important therapies may increasingly be developed
primarily in China.
10. Uncertainty Remains
o While ivonescimab has shown strong results in China, mixed findings
from global trials involving Western patients have raised questions about whether
the drug's success can be replicated worldwide. The FDA is expected to decide on
approval later this year.
Key Takeaway:
China has become a major force in pharmaceutical innovation, particularly in cancer
treatments, creating both opportunities for faster drug development and concerns
in the United States about competitiveness, data reliability, and long-term healthcare
dependence.
[ABS News Service/30.05.2026]
For
decades, an annual gathering of oncologists has featured drug trials that were run
mainly at American and European hospitals.
But
at this year’s meeting, which is being held in Chicago this weekend, the signs are
everywhere of China’s ascendance as a powerhouse in drug development — and of the
threat that many believe it poses to American biotechnology.
The
clearest sign: In what appears to be a first, one of the conference’s five coveted
headliners will be a presentation of a clinical trial conducted only in China.
That
milestone at the meeting of the American Society of Clinical Oncology, or ASCO,
reflects the dizzying growth of China’s biotechnology sector. In just a few years,
it has transformed from a sleepy industry into a juggernaut rapidly inventing and
testing cutting-edge medicines.
“This
tells us that the Chinese biotech industry has arrived,” said Dr. Otis Brawley,
a professor at Johns Hopkins who has attended the ASCO meeting every year since
1989.
But
a growing contingent of U.S. officials, executives and doctors worry that the shift
in drug innovation to China poses dangerous risks for research, American patients
and biotech workers. They raise concerns about losing control over new medicines
and about ceding America’s longstanding dominance in the field.
With
Chinese companies churning out patents, papers in medical journals and new clinical
trials, U.S. biotech start-ups say they are struggling to keep up and are facing
deep disadvantages.
“I
think the concerns are valid and very real,” said Dr. Robert Califf, a former commissioner
of the Food and Drug Administration. “The U.S. is being seriously threatened.”
As
tensions between Washington and Beijing have escalated, Democrats and Republicans
have sounded the alarm about America’s reliance on China for generic drugs and raw
materials.
Taking
particular aim at China, President Trump signed legislation that barred government
agencies from contracting with certain foreign biotech service providers in adversarial
countries. China’s surge into cutting-edge drug development introduces a new dimension
of risk, critics say.
There
is another worry. Will drugs work as well in American patients as they do in Chinese
patients?
For
reasons that researchers do not fully understand, Asian patients with lung cancer
tend to live longer and respond better to immunotherapies than people of other ethnicities,
according to some studies.
Yet
China has a very high rate of smoking, and former smokers tend to fare worse when
they get lung cancer. Further complicating the picture is differences in treatment
— the cancer drugs typically used in China are often not the same as in the United
States.
“In
general, things look better in China,” said Dr. Peter Marks, who was a longtime
F.D.A. official before resigning last year. “It’s a fraught area right now. I think
many of us have real concerns.”
Dr.
Marks, who has since joined Eli Lilly as an executive overseeing its work on infectious
diseases, stressed that he was not speaking for Lilly.
On
the other side of the debate are those who warn that throttling competition from
China would deprive Americans of new medicines. Ultimately, they say, the best data,
no matter where it comes from, should win out.
In
clinical trials, “patients either do well or they don’t, at the end of the day,”
said Bob Duggan, a co-chief executive of Summit Therapeutics, based in Miami.
Summit
bought the rights to the experimental drug from China, ivonescimab,
that will get top billing at ASCO. The company is testing the drug in separate studies
in American patients, and is seeking to bring it to market in the United States
and other parts of the world. The Chinese company that invented the drug, Akeso Biopharma, already sells it in China.
China’s rising influence
In
the last few years, the world’s biggest pharmaceutical companies have been filling
their pipelines by turning to China, where prices are low, regulatory hurdles are
fewer, and development timelines are quick.
So
far this year, about half of such major deals involved a drug from China, up from
next to nothing in the 2010s, according to DealForma,
which tracks drug industry transactions.
That
trend will be on vivid display at ASCO. Beyond ivonescimab,
other presentations feature experimental cancer drugs invented and tested in China
that have been scooped up by big drugmakers like Pfizer, Merck and Bristol Myers
Squibb.
In
particular, the drug bought by Merck impressed the field with results, announced
earlier this month, showing it slowed tumor progression
in Chinese patients with advanced lung cancer.
A
Chinese company typically retains the rights to sell its drug in China. The big
drugmakers buy the U.S. rights, spurning offerings from American start-ups that
are developing similar medicines.
Critics
of China also point to an increasingly worrisome pattern. Chinese drug developers
race to essentially copy U.S. inventions. As protection, some U.S. biotech start-ups
have imposed new measures to maintain secrecy, like refusing to publish papers or
present posters at conferences.
As
Robert F. Kennedy Jr., the U.S. health secretary, put it to lawmakers at a hearing
in April: “China is eating our lunch.”
In
March, Chris Klomp, one of Mr. Kennedy’s top lieutenants, described the current
climate to those attending the Conservative Political Action Conference. “It’s not
one of missiles and tanks,” he said. “It’s of laboratories and lifesaving medications.
It’s a war right now with China on American innovation and biotechnology.”
For
now, big multinational pharmaceutical companies are developing most drugs invented
in China for introduction to the U.S. market. But some fear that if more Chinese
companies assume a direct role, American patients could become dangerously reliant
on the Chinese government for access to vital brand-name drugs.
There
is a risk, Dr. Marks said, of “creating a new Strait of Hormuz.”
Representative
John Moolenaar, a Republican from Michigan, has called for prohibiting the F.D.A.
from reviewing data from China and curbing the deal making between major U.S. drugmakers
and Chinese companies. But his proposals have not gained much traction.
Dr.
Richard Pazdur, who was the F.D.A.’s longtime top cancer drug regulator and briefly
led its broader drug division late last year, was well-known for refusing to approve
cancer drugs based on data collected only in China.
Now,
“regulators must prepare for an environment in which some therapies with substantial
patient benefit may be studied primarily, or even exclusively, in China,” Dr. Pazdur warned in an opinion piece in JAMA that he co-wrote in
March.
Emily
Hilliard, a spokeswoman for the Department of Health and Human Services, said the
F.D.A. evaluates whether trials are “adequate and well-controlled, reliable and
applicable to the U.S. patient population the drug is intended to address.”
ASCO’s global clout
Seven
oncologists founded ASCO in the United States in 1964, and as the field has grown
globally, so has the organization.
In
the world of cancer research, there are few greater honors
than winning one of four or five top-billed presentation slots at the annual conference.
Oncologists around the world identify and select the most important, practice-shifting
science.
ASCO’s
chief executive, Dr. Clifford Hudis, said this was the first time the group could
recall one of those spots going to a study that enrolled patients only in China.
The closest precedent was in 2021, when one headliner involved a trial of an immunotherapy
drug that was conducted mostly in China, with a few sites in Taiwan and Singapore.
Dr.
Hudis said that his organization was “focused on results that can improve outcomes
for patients, regardless of where they live.”
But
this year’s unusual selection has been generating buzz in medical circles for weeks.
Christoph Westphal, a biotech venture capital investor, called the top billing at
the conference “a coming-of-age moment for China.”
China’s lung cancer drug
The
moment of truth for the China-only study of ivonescimab
comes on Sunday, when data will be presented.
The
drug, given as an IV infusion, combines two attacks on a tumor.
It unleashes the immune system with one strategy and deprives the tumor of a blood supply with another.
The
study, involving more than 500 patients newly diagnosed with advanced lung cancer,
looked at survival rates in a group that received the drug and
in a group treated with a different immunotherapy. (Both groups also underwent
chemotherapy.)
The
drug used in the comparison group, Tevimbra, is not approved
for lung cancer in the United States, where patients typically get the blockbuster
immunotherapy Keytruda along with chemotherapy.
Because
the Chinese trial did not examine whether its drug extended lives longer than Keytruda
did, U.S. oncologists will have to try to parse what the results mean for U.S. patients,
said Dr. Roy Herbst, the incoming director of the Dartmouth Cancer Center.
Akeso, which funded the study, declined an interview
request.
Summit
has applied for F.D.A. approval of ivonescimab based on
the results of a global study in the United States, Canada and Europe. The F.D.A.
said it would decide by November whether to approve the drug.
In
April, Summit disclosed early results from another key global study with American
patients that sharpened questions about how well ivonescimab
will work outside of China. The company said the drug failed to meet a statistical
bar that, if successful, might have expedited regulatory approval.
The
disappointing results sunk Summit’s stock. Now, the company will wait for the study’s
final data, expected later this year.