China’s rise in drug development threatens the United States
For decades, drug trials conducted primarily in American and European hospitals have been presented at an annual meeting of oncologists.
But at this year’s meeting, taking place this weekend in Chicago, signs of China’s emergence as a leader in drug development – and the threat many see it as to American biotechnology – are everywhere.
The clearest sign: One of the conference’s five coveted headliners will, apparently for the first time, be the presentation of a clinical trial that is only being carried out in China.
This milestone at the American Society of Clinical Oncology (ASCO) meeting reflects the dizzying growth of China’s biotechnology sector. In just a few years, it has transformed from a sleepy industry into a juggernaut that is rapidly inventing and testing cutting-edge drugs.
“This shows us that the Chinese biotech industry has arrived,” said Dr. Otis Brawley, a professor at Johns Hopkins University who has attended the ASCO meeting every year since 1989.
But a growing number of U.S. officials, executives and doctors fear that shifting drug innovation to China poses dangerous risks for research, American patients and biotech workers. They raise concerns about the loss of control over new drugs and the abandonment of America’s long-standing dominance in the field.
As Chinese companies churn out patents, medical journal publications and new clinical trials, U.S. biotech startups say they are struggling to keep up and face significant disadvantages.
“I think the concerns are legitimate and very real,” said Dr. Robert Califf, a former commissioner of the Food and Drug Administration. “The United States is under serious threat.”
As tensions escalated between Washington and Beijing, Democrats and Republicans raised the alarm about America’s dependence on China for generic drugs and raw materials.
With a particular focus on China, President Trump signed a law banning government agencies from contracting with certain foreign biotech service providers in hostile countries. Critics say China’s push to develop cutting-edge medicines brings a new dimension of risk.
There is another concern. Will drugs work as well on American patients as they do on Chinese patients?
For reasons that researchers don’t fully understand, Asian patients with lung cancer tend to live longer and respond better to immunotherapies than people of other ethnic backgrounds, according to some studies.
Still, smoking rates are very high in China, and former smokers tend to fare worse when they develop lung cancer. To make matters worse, there are differences in treatment – the cancer drugs commonly used in China are often not the same as those in the United States.
“In general, things are looking better in China,” said Dr. Peter Marks, who was a longtime FDA official before resigning last year. “It’s a tense area at the moment. I think a lot of us have real concerns.”
Dr. Marks, who has since joined Eli Lilly as an executive overseeing its work in infectious diseases, emphasized that he does not speak for Lilly.
On the other side of the debate are those who warn that curbing competition from China would deprive Americans of new medicines. Ultimately, they say, the best data should prevail, no matter where it comes from.
In clinical trials, “patients either end up doing well or they don’t,” said Bob Duggan, co-chief executive of Miami-based Summit Therapeutics.
Summit bought the rights to the experimental drug Ivonescimab from China, which will top the list at ASCO. The company is testing the drug in separate studies on American patients and wants to market it in the U.S. and other parts of the world. The Chinese company Akeso Biopharma, which invented the drug, is already selling it in China.
China’s growing influence
In recent years, the world’s largest pharmaceutical companies have filled their pipelines by turning to China, where prices are low, regulatory hurdles are lower and development timelines are short.
According to DealForma, which tracks pharmaceutical industry transactions, about half of those large deals so far this year have involved a drug from China. In the 2010s there were almost no deals.
This trend is clearly visible at ASCO. In addition to ivonescimab, other presentations will feature experimental cancer drugs invented and tested in China that have been acquired by major drugmakers such as Pfizer, Merck and Bristol Myers Squibb.
In particular, the drug purchased by Merck impressed experts with results announced earlier this month showing that it slowed tumor growth in Chinese patients with advanced lung cancer.
A Chinese company usually retains the rights to sell its drug in China. The major drugmakers are buying the U.S. rights and rejecting offers from American startups developing similar drugs.
Critics of China also point to an increasingly worrying pattern. Chinese drug developers are vying to essentially copy U.S. inventions. To protect themselves, some US biotech start-ups have introduced new measures to maintain secrecy, such as refusing to publish papers or present posters at conferences.
As Robert F. Kennedy Jr., the U.S. secretary of health and human services, told 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 attendees at the Conservative Political Action Conference. “This is not about missiles and tanks,” he said. “It’s about labs and life-saving drugs. It’s currently a war with China against American innovation and biotechnology.”
Currently, major multinational pharmaceutical companies are developing most drugs invented in China for introduction into the U.S. market. But some fear that if more Chinese companies take a direct role, American patients could become dangerously reliant on the Chinese government for access to vital brand-name drugs.
There is a danger, said Dr. Marks, “the creation of a new Strait of Hormuz.”
Rep. John Moolenaar, a Republican from Michigan, has called for banning the FDA from reviewing data from China and curbing deals between major U.S. drugmakers and Chinese companies. But his suggestions haven’t gained much traction.
Dr. Richard Pazdur, who long served as the FDA’s top cancer drug regulator and briefly led its broader drug division late last year, was known for denying approval of cancer drugs based on data collected only in China.
Now “regulators must prepare for an environment in which some therapies with significant patient benefit may be studied primarily or even exclusively in China,” Dr. Pazdur in an opinion piece in JAMA that he co-authored in March.
Emily Hilliard, a spokeswoman for the Department of Health and Human Services, said the FDA is evaluating whether studies are “adequate and well-controlled, reliable and applicable to the U.S. patient population to which the drug is intended.”
ASCO’s global clout
Seven oncologists founded ASCO in the United States in 1964, and as the field grew worldwide, so did the organization.
In the world of cancer research, there are few greater honors than winning one of four or five highly prized speaking slots at the annual conference. Oncologists around the world identify and select the most important and practice-changing scientific findings.
ASCO’s CEO, Dr. Clifford Hudis, said this was the first time the group could recall one of these locations participating in a study involving only patients in China. The closest precedent was in 2021, when a headline report involved a study of an immunotherapy drug conducted primarily in China, with some sites in Taiwan and Singapore.
Dr. Hudis said his organization is “focused on outcomes that can improve outcomes for patients, regardless of where they live.”
But this year’s unusual selection has been causing a stir in medical circles for weeks. Dr. 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 the data are presented.
The drug, administered as an intravenous infusion, combines two attacks on a tumor. One strategy activates the immune system, while another strategy deprives the tumor of its blood supply.
The study, which included more than 500 patients with newly diagnosed advanced lung cancer, looked at survival rates in a group that received the drug and a group that was treated with another immunotherapy. (Both groups also received chemotherapy.)
The drug used in the comparison group, Tevimbra, is not approved for lung cancer in the US, where patients typically receive the blockbuster immunotherapy Keytruda in addition to chemotherapy.
Because the Chinese trial didn’t examine whether its drug extends life longer than Keytruda, U.S. oncologists must try to analyze what the results mean for U.S. patients, Dr. Roy Herbst, the new director of the Dartmouth Cancer Center.
Akeso, which funded the study, declined an interview request.
Summit has applied for FDA approval of ivonescimab based on the results of a global trial in the United States, Canada and Europe. The FDA said it will decide by November whether to approve the drug.
In April, Summit released early results from another important global trial in American patients, raising questions about how well ivonescimab will work outside China. The company said the drug failed to meet a statistical hurdle that, if successful, would have accelerated regulatory approval.
The disappointing results caused Summit’s stock to fall. The company is now waiting for the study’s final data, which is expected later this year.
