Clinical Going Global: Why Australia and Europe Matter More for Chinese Biotech

For Chinese biotech companies, global clinical development is becoming more important earlier in the asset-development process. Under existing U.S. regulations, FDA may accept foreign clinical studies if they are well designed, well conducted, follow good clinical practice, and can be validated by FDA when necessary (21 C.F.R. § 312.120). FDA regulations also allow marketing approval based solely on foreign clinical data if the data are applicable to the U.S. population and U.S. medical practice, the investigators are qualified, and FDA can validate the data if needed (21 C.F.R. § 314.106).

However, China-only clinical packages now face higher practical risk. The clearest example is sintilimab. In 2022, FDA’s Oncologic Drugs Advisory Committee voted 14–1 that additional clinical trial data should be required before FDA made a regulatory decision for sintilimab in first-line nonsquamous non-small-cell lung cancer. The supporting ORIENT-11 trial was conducted entirely in China, and the committee raised concerns about whether the data were applicable to U.S. patients and U.S. medical care (Harris, 2022). More recently, U.S. FY2027 appropriations materials included policy language that would prohibit FDA from accepting certain IND-supporting clinical data generated at clinical investigation sites in “covered nations,” including China. This should be treated as a policy signal rather than a fully enacted FDA rule, but it still shows that the geography of clinical data is becoming part of U.S. biosecurity discussions (National Security Commission on Emerging Biotechnology, 2026).

In this environment, Chinese biotech companies with global ambitions may need to move from a “China-first, global-later” model to a “global-by-design” model. The core question is not simply where the molecule was discovered, but whether the clinical package can travel across regulatory systems. Trial design, patient population, standard of care, comparator choice, endpoint selection, data quality, inspection readiness, and regional diversity all become important.

Australia is attractive mainly for early clinical development. Australian clinical trials involving unapproved therapeutic goods can be conducted under the Clinical Trial Notification or Clinical Trial Approval schemes, and the CTN pathway places an important role on ethics and institutional approval before trial conduct (Therapeutic Goods Administration, 2025a, 2025b). Australia also offers an R&D Tax Incentive; for eligible companies with aggregated turnover below AUD 20 million, the refundable R&D tax offset equals the corporate tax rate plus an 18.5% premium (Australian Government, n.d.). For Chinese biotech companies, this can make Australia useful for Phase 1, first-in-human, and early proof-of-concept studies, especially when the goal is to generate data in an internationally recognized clinical environment.

Europe is important for a different reason: multi-country clinical development. Through the Clinical Trials Information System, sponsors can apply to run and manage clinical trials in up to 30 EU/EEA countries through a single online application (European Medicines Agency, n.d.). This makes Europe useful for programs that need broader patient diversity, multi-country recruitment, and regulatory credibility beyond a single domestic market. Europe is also aligned with the ICH E17 framework, which encourages multi-regional clinical trial design to improve the acceptability of clinical data across regulatory regions (U.S. Food and Drug Administration, 2018).

For Chinese biotech, the takeaway is practical. China remains a major source of innovation, patient recruitment, manufacturing, and clinical-development capability. But for assets intended for global markets, relying only on China-generated clinical data may create avoidable regulatory and business-development risk. Australia can be useful for efficient early clinical development, while Europe can strengthen multi-regional evidence generation. The strongest strategy is not simply “clinical overseas,” but clinical development that is designed from the beginning for global regulatory acceptance.

References

21 C.F.R. § 312.120. Foreign clinical studies not conducted under an IND.

21 C.F.R. § 314.106. Foreign data.

Australian Government. (n.d.). Overview of the R&D Tax Incentive. business.gov.au.

European Medicines Agency. (n.d.). Clinical Trials Information System.

Harris, J. (2022, February 10). ODAC recommends new trial data of sintilimab in US population of frontline NSCLC. OncLive. https://www.onclive.com/view/odac-votes-against-frontline-sintilimab-chemo-for-nonsquamous-nsclc

National Security Commission on Emerging Biotechnology. (2026). FY27 appropriations: Clinical trial data from foreign adversaries.

Therapeutic Goods Administration. (2025a). Clinical trials.

Therapeutic Goods Administration. (2025b). Clinical Trial Notification (CTN) scheme.

U.S. Food and Drug Administration. (2018). E17 general principles for planning and design of multi-regional clinical trials. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e17-general-principles-planning-and-design-multi-regional-clinical-trials#:~:text=Consumers-,Regulatory%20Information,Final