Decades of dominance in oncology drug trials conducted at American and European hospitals are being upended as China’s biotechnology sector rapidly ascends. At this year’s American Society of Clinical Oncology (ASCO) conference in Chicago, a landmark event will feature a clinical trial conducted exclusively in China — marking the first time the prestigious event has spotlighted research without U.S. patient involvement.
The presentation of a China-only study for the experimental lung cancer drug ivonescimab reflects Beijing’s staggering transformation from a lagging pharmaceutical industry to a global innovator. In recent years, China has evolved into a biotech juggernaut, swiftly developing and testing cutting-edge therapies while securing a growing share of international drug development deals.
“This tells us that the Chinese biotech industry has arrived,” said Dr. Otis Brawley, a Johns Hopkins professor attending ASCO since 1989. However, U.S. officials, executives, and researchers express alarm over China’s rise, warning of risks to research integrity, patient safety, and America’s long-held leadership in biotechnology.
The surge has forced U.S. biotech startups to grapple with mounting disadvantages. Companies like Summit Therapeutics, which acquired ivonescimab’s rights from Chinese developer Akeso Biopharma, face challenges as Chinese firms dominate licensing deals. Critics argue that China’s rapid advancements — including patent filings, medical journal publications, and clinical trials — are outpacing domestic competitors.
“The U.S. is being seriously threatened,” stated Dr. Robert Califf, former FDA commissioner. Meanwhile, President Trump’s legislation barring contracts with foreign biotech firms in adversarial nations underscores escalating tensions. Concerns extend to whether drugs developed in China will perform as effectively in U.S. patients, particularly given differences in demographics, treatment protocols, and smoking rates. For example, while Chinese lung cancer patients respond robustly to immunotherapies, high smoking rates complicate outcomes for former smokers.
FDA officials emphasize rigorous evaluation of trial validity, but regulatory discomfort persists. Former FDA official Dr. Richard Pazdur refused to approve drugs based solely on Chinese data, while current leaders warn of preparing for therapies studied primarily in China. Proposals to block FDA review of Chinese data, though gaining little traction, highlight fears of over-reliance on foreign therapies, likened to the “Strait of Hormuz” analogy for critical resource dependency.
Yet advocates caution against stifling competition, noting that data quality should ultimately prevail. Summit Therapeutics’ CEO Bob Duggan stresses that patient outcomes matter most: “Patients either do well or they don’t.” The ASCO conference will spotlight China’s growing influence, with half of major drug deals in 2023 involving Chinese inventions, up from negligible levels in the 2010s.
ASCO’s global reach, founded by U.S. oncologists in 1964, now features presentations from Chinese-developed drugs acquired by Pfizer, Merck, and Bristol Myers Squibb. While Chinese companies retain domestic rights, U.S. firms secure global markets. However, concerns about intellectual property theft persist, with some U.S. startups withholding research to protect innovations.
Health Secretary Robert F. Kennedy Jr. framed the rivalry as a “war” over laboratories and lifesaving medicines. As China’s biotech sector redefines global competition, debates intensify over balancing collaboration with safeguards. Akeso’s ivonescimab trial, presented Sunday, will gauge China’s credibility — though Summit’s recent FDA application faces scrutiny after mixed results in non-Chinese trials. The FDA’s decision by November will test the resolve of a sector grappling with China’s meteoric rise and the risks it entails.
