China’s rapid human trials draw western drugmakers — and safety concerns

{"text":[[{"start":12.22,"text":"Western drugmakers have spent record sums on medicines developed in China in recent years. Now they are going one step further — using Chinese hospitals to test experimental cell and gene therapies on humans for the first time."}],[{"start":25.14,"text":"Over the past 18 months pharma groups, including AstraZeneca, Sana Biotechnology and Tempest Therapeutics, have pursued so-called investigator-initiated trials (IITs) with Chinese partners to take advantage of a fast-track route into clinical testing."}],[{"start":40.68,"text":"The trend signals a new stage in western pharma’s reliance on China. Foreign biotechs have turned to the country to license novel drugs or conduct research in recent years but are now entrusting Chinese hospitals to test experimental drugs in patients earlier than would be allowed in their own countries."}],[{"start":57.52,"text":"“A western biotech would previously only run clinical trials in China later in the drug development cycle when a drug was already close to commercialisation,” said Jerry Wu, venture partner at UK-based biotech investment group LongRiver Investments. “Now the model has changed. They are coming to China from the beginning.”"}],[{"start":76,"text":"Foreign groups are increasing their involvement in such studies despite concerns about patient safety and oversight following two recent deaths."}],[{"start":83.64,"text":"Unlike conventional industry-sponsored studies, IITs are led by hospital researchers. Although Beijing has tightened the rules governing them this year, the Chinese IIT system still provides an unusually rapid path to human testing for certain cutting-edge treatments, allowing companies to generate preliminary data before committing to the more extensive trials needed to bring a drug to market."}],[{"start":null,"text":"

"}],[{"start":105.4,"text":"A record 282 IITs were launched in China in 2025, up from 63 a decade ago, according to data from Citeline, which tracks clinical trials. Western companies seeking to test novel cell and gene therapies — including on children with rare life-threatening conditions — make up a small but growing part of that group."}],[{"start":125.64,"text":"Dozens of western groups have disclosed they are taking part in IITs with local hospitals and Chinese biotech groups in the past five years, according to Citeline. The true number is likely far larger because biotechs do not always disclose their research, and often choose not to do so in order to prevent imitation."}],[{"start":null,"text":""}],[{"start":143.22,"text":"The rise in IITs underlines China’s emergence as a global centre for medical research and development. The country has built a sprawling network of academic hospitals staffed with specialist researchers and boasts a booming domestic biotechnology industry, as well as a large population to be enrolled in clinical trials. Chinese trials enrol patients two to five times faster than in the US, according to McKinsey research."}],[{"start":168.2,"text":"“PIs [principal investigators] at leading hospitals in China have become highly experienced and often handle large patient volumes,” said Andrew Fang, a consultant advising Nasdaq-listed Tempest Therapeutics on its collaboration with Chinese biotech Hebei Senlang. Hebei Senlang is facilitating the human trial of Tempest’s experimental treatment for autoimmune diseases at a local hospital."}],[{"start":190.2,"text":"“One PI at a leading Chinese hospital may handle substantially more patients than a counterpart at a comparable US institution,” Fang said."}],[{"start":198.44,"text":"That experience can be particularly valuable for first-in-human studies, designed to test an experimental treatment’s safety and tolerability, identify potential side effects and determine dosing before moving to larger trials."}],[{"start":null,"text":""}],[{"start":211.32,"text":"IITs are neither unique to China nor confined to early-stage drug development. But China’s fast-track route for pioneering therapies allows such trials to proceed following science and ethics reviews, without obtaining the national regulatory approval required for a conventional study."}],[{"start":227.6,"text":"Its dual-track system has helped make the country a hub for testing experimental treatments such as chimeric antigen receptor cell (Car-T) therapies in humans, particularly in oncology but also for rare genetic diseases."}],[{"start":241.16,"text":"Car-T therapies are treatments in which a patient’s own immune cells are modified to attack specific cells. The research is a priority area for pharma groups, including Britain’s AstraZeneca, which has collaborated with Chinese hospitals on several IITs. Those include testing a Car-T treatment for liver cancer, designed by AstraZeneca and developed with Chinese biotech AbelZeta, in a 36-patient trial led by a Zhejiang University School of Medicine hospital."}],[{"start":268.6,"text":"The company also worked with Peking University on a trial for a Car-T therapy targeting gastrointestinal cancers that it later discontinued. In a press release in August it said cell therapy played “a pivotal role in our ambition to eliminate cancer as a cause of death.” It did not respond to a request for comment on its involvement in Chinese IITs."}],[{"start":null,"text":""}],[{"start":287.68,"text":"In an FT analysis of 15 Nasdaq-listed companies that disclosed they were working on Chinese IITs, many told investors they were doing so in order to generate rapid and cost-effective early-stage data to inform more extensive industry-sponsored trials."}],[{"start":302.84,"text":"Those include Dutch biotech ProQR, which said in an SEC filing in May that it planned to pursue an IIT in China in children with a rare liver disease, rather than proceed with a previously planned European trial in adults with a different liver condition. Following the shift in its research priorities, it said the IIT would provide a “more direct path to early data generation in the target patient population”."}],[{"start":326.48,"text":"Yao Zhizhong, partner at Paris-based life sciences fund Sofinnova Partners, said Chinese IITs were a “de-risking” step for western groups, generating early results on the efficacy of a drug candidate that could help companies raise fresh funding or attract acquisition bids."}],[{"start":342.58,"text":"Last year EsoBiotec, a Belgian start-up that had recently generated early human data for its Car-T cancer drug in an IIT in Wuhan, became one such company when it was bought by AstraZeneca for up to $1bn. Yao said the case — in which a start-up managed to leapfrog much larger rivals in publishing results on a highly anticipated cancer treatment — demonstrated how China could act as an “accelerator for science”."}],[{"start":367.12,"text":"“An increasing number of international biotech CEOs are coming to China to find partners to run IITs with them. They recognise the clinical resources available in China and the experience and efficiency of these research teams,” said Fang."}],[{"start":null,"text":""}],[{"start":380.68,"text":"However, western pharma groups’ growing reliance on Chinese clinical trials has triggered rising anxiety among US lawmakers, raising the spectre of future national security restrictions. In a June letter to Bristol Myers Squibb, Republican congressman John Moolenaar said China had “transformed itself into the cheapest and fastest place in the world to run early-stage human drug trials”, adding enrolment was “accelerated by its lack of ethical safeguards surrounding informed consent and voluntary participation”."}],[{"start":410.6,"text":"The letter was one of four sent to US pharma companies requesting more information about their work in China."}],[{"start":415.94,"text":"The IIT route is also becoming more difficult within China itself. Beijing has tightened the rules governing IITs this year, leading to potential delays to a pathway western groups have seized on for its speed."}],[{"start":429.86,"text":"China’s new regulations were announced months before it emerged that two children had died in gene-editing studies, raising questions over the oversight of IITs and whether patients and their families were adequately informed of the risks."}],[{"start":443.56,"text":"News of the deaths, the first reported in Science magazine and the second disclosed by the company, came months after the government introduced order 818 — tougher rules for clinical research involving “new biomedical technologies” such as cell therapies and brain implants."}],[{"start":459.74,"text":"Under the new regulations, only so-called Sanjia hospitals — those with the best researchers and access to patient populations can conduct IITs — and hospitals and companies can be fined for breaking them. The new rules also introduce a new national filing requirement."}],[{"start":477.06,"text":"Aaron Gu, a biotech lawyer at Han Kun Law Offices, said the rules meant that hospitals had “increased the regulatory thresholds, introducing new measures like longer toxicity studies than before”, but added they should not cause any issues for foreign biotechs given the high standards they already adhered to."}],[{"start":494.5,"text":"Sana Biotechnology, a Seattle-based company developing cell therapies, said progress on its IIT had been delayed because of the stricter regulations. Chief executive Steven Harr said: “Things that used to be rubber stamps, per se, are now signatures,” but added: “It is not changing the outcome, but it has slowed things down.”"}],[{"start":514.1,"text":"Lawyers and biotechnology companies claimed China’s new rules would not dent the overall appeal of IITs as a faster-track route to early-stage human data than was possible in other countries, however."}],[{"start":525.9,"text":"Gu said: “China is faster not just because of regulation. It’s about the entire industry — the clinical research organisations, suppliers and hospitals all working very hard.”"}],[{"start":537.58,"text":"Additional reporting by Aanu Adeoye"}],[{"start":544.98,"text":""}]],"url":"https://audio.ftcn.net.cn/album/a_1792756224_5224.mp3"}