China is rapidly becoming a key driver in the development of precision oncology drugs, facilitated by its rising cancer incidence, proactive government policies, and an influx of biopharma investment. China accounted for nearly a quarter of all global cancer diagnoses, with about 5 million new cases reported in 2022. This public health challenge has driven unprecedented growth in oncology clinical trials, with China reportedly eclipsing the United States this year as the world’s leading location for oncology clinical trials.
Government policies, specifically the revised Drug Administration Law implemented in late 2019, support the rapid development of oncology drugs to meet China’s significant unmet medical needs. Some of the key regulatory policies include breakthrough therapy designation, priority review pathways, and submission of clinical trial data from multi-regional clinical trials. Such policies lead to conducting trials more quickly, thus helping to shorten the time of approval from more than 200 days to as low as 60 days for certain in-demand oncology drugs. As a result, China is now a very important clinical trial location in terms of global cancer research.
However, there are complex challenges and drawbacks in conducting oncology trials in China, including regulations related to human genetic resources and data security laws. The Human Genetic Resources Administration of China (HGRAC) requires prior approval for the collection and transportation of genetic material, which often requires foreign drug companies to engage with a Chinese partner, and this may extend the timelines.
China is also placing importance on high-quality clinical trial data. According to the inspections carried out by the U.S. FDA, the quality of trial data in China has improved remarkably: more than 80% of the country’s inspections from 2016 through 2023 resulted in No Actions Indicated. However, experts warn that consistency of data remains a problem since there are sometimes insufficient quality management systems at emerging cancer institutions.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.