China's Clinical Trial Window Is Open. The Question Is Whether Your Structure Is Ready.
China leads in clinical trial volume, but advantage depends on HGR, CRO, and entity structure before the first patient is enrolled.
This article is a follow-up to China’s Emerging Role in Global Clinical Trial Outsourcing, which covered why China has become a strategic hub for clinical research and CRO partnership. Here the focus shifts to the structural decisions that determine whether sponsors can actually capture that advantage.
The question our clients ask most often about clinical trials in China is whether the regulatory system has improved enough to make it worth the effort.
It has.
The question they rarely think to ask is whether their operational structure is built to capture the advantage.
China surpassed the US in clinical trial volume by roughly 18 percent in 2024, according to WHO registry data. That did not happen by accident.
Cheap labour is not the story. China’s clinical trial infrastructure has been rebuilt from scratch over seven years and it shows. Before 2018, getting approval to start a trial in China took about 18 months on average. That pathway now takes 30 working days from acceptance for eligible Class I innovative drugs, including those in globally synchronised development programmes, under NMPA Announcement No. 86 (2025). Direct costs in China ran around 30 percent below US levels, and recruitment could often be two to three times faster, according to a 2019 Drug Information Association analysis. Treatment-naive patients have not yet received any therapy for their condition. China has a large pool of them: it recorded over one million new lung cancer cases in 2022, against roughly 230,000 in the US, according to GLOBOCAN cancer registry data.
The question now is whether you are starting early enough to benefit.
The companies extracting the most from China’s clinical environment are not running separate, later-stage programmes to save money on a trial already designed elsewhere. They are including Chinese cohorts in global pivotal trials from Phase I, so that a single dataset supports submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the NMPA simultaneously. Pivotal trials are the late-stage studies whose results go directly to regulators for approval decisions. That approach became possible when China joined the International Council for Harmonisation (ICH) in 2017, aligning its standards with those governing data accepted in the US and Europe. After 31 March 2026, all Chinese drug clinical trials operate under the updated ICH Good Clinical Practice standard, E6(R3). China’s fully revised Good Clinical Practice regulations, which incorporate E6(R3) by reference, took effect in September 2026.
Belgian biotech EsoBiotec initiated a trial in China in December 2024 for a novel chimeric antigen receptor T-cell (CAR-T) therapy, a technique that engineers immune cells to target cancer from inside the patient’s body. On 8 January 2025, the company announced that the first patient had been treated. Within ten weeks of announcing that first dosing, AstraZeneca agreed to acquire EsoBiotec for up to one billion US dollars. At the point of the deal, formal clinical data had not yet been published. This is not a cost story. It is a commercial optionality story.
Getting into China for clinical trials is no longer the hard part. Getting the structure right before you start is.
The complications that remain are not clinical. They are the kind of decisions a company makes when setting up any regulated China operation: entity structure, data governance, regulatory compliance. They need to be made before the trial starts, not during it. None of them require clinical trial expertise to resolve. They require China expertise.
Human Genetic Resources Compliance
Any trial in China involving biological samples falls under China’s Regulations on the Management of Human Genetic Resources (HGR). Blood draws, tissue samples, genetic data: all regulated. Before biological samples or the data derived from them can leave China for analysis, filing with the National Health Commission is required. Collections conducted to obtain drug marketing approval are exempt from collection approval, but not from the data export and international cooperation filing requirement, which applies regardless of trial type. The question to resolve before signing anything: has your protocol been reviewed for HGR compliance, and is the filing process built into your start date?
Contract Research Organisation Governance and Legislative Exposure
The legislative environment around Chinese Contract Research Organisations (CROs) in the US has moved faster than most procurement cycles. The BIOSECURE Act, signed into law in December 2025 as part of the US defence authorisation bill, will restrict US federal agencies from contracting with designated Chinese biotechnology companies. The designation list is due by December 2026, and the first prohibitions are not expected to take effect until 2028. A contract signed today may face a materially different compliance environment before the trial concludes. Most European innovative drugs seek FDA approval, and that creates indirect exposure through data governance and US partner contracts regardless of how the regulatory situation develops. Select a CRO whose ownership structure and data governance terms protect you if that changes.
Entity Structure and Data Ownership
Someone needs to be the legal sponsor of record for the trial in China. The options are a Wholly Foreign-Owned Enterprise (WFOE), a partnership with a Chinese CRO or hospital, an Employer of Record arrangement for local staff, or a holding structure established outside China. The choice determines who owns the data and who is accountable to the NMPA if something goes wrong. Both matter more than they appear to at the contract stage. A company that signs a trial agreement with a Chinese CRO before resolving its entity structure has effectively made that decision by default, and default outcomes in this area rarely favour the foreign partner. Decide this before the protocol is finalised. A company that begins enrolling patients without a documented answer to who owns the data has already answered the question, usually in the CRO’s favour.
The Window Is Open
Cost, speed, and a single dataset covering three regulatory submissions are all achievable. The reason companies underperform is almost always a structural decision that was not made before the trial started. Has yours been made?
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