China’s rise in drug development looms over US

[NEW JERSEY] 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 US 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 long-standing dominance in the field.

With Chinese companies churning out patents, papers in medical journals and new clinical trials, US biotech startups 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 (FDA). “The US 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.

SEE ALSO

Taking particular aim at China, US President Donald 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 FDA official before resigning last year. “It’s a fraught area right now. I think many of us have real concerns.”

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 US 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 US rights, spurning offerings from American startups that are developing similar medicines.

Critics of China also point to an increasingly worrisome pattern. Chinese drug developers race to essentially copy US inventions. As protection, some US biotech startups have imposed new measures to maintain secrecy, like refusing to publish papers or present posters at conferences.

As Robert F Kennedy Jr, the US health secretary, put it to lawmakers at a hearing in April: “China is eating our lunch.”

In March, Chris Klomp, one of 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 US 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, Marks said, of “creating a new Strait of Hormuz”.

Representative John Moolenaar, a Republican from Michigan, has called for prohibiting the FDA from reviewing data from China and curbing the dealmaking between major US drugmakers and Chinese companies. But his proposals have not gained much traction.

Dr Richard Pazdur, who was the FDA’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”, Pazdur warned in an opinion piece in the journal Jama that he co-wrote in March.

Emily Hilliard, a spokesperson for the Department of Health and Human Services, said the FDA evaluates whether trials are “adequate and well-controlled, reliable and applicable to the US patient population the drug is intended to address”.

Asco’s global clout

Seven oncologists founded Asco in the US in 1964, and as the field has grown globally, so has the organisation.

In the world of cancer research, there are few greater honours 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.

Hudis said that his organisation 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 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 US, 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, US oncologists will have to try to parse what the results mean for US 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 FDA approval of ivonescimab based on the results of a global study in the US, Canada and Europe. The FDA 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 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. THE NEW YORK TIMES