The Biotech Landscape: Opportunities In China And The Path To USFDA Approval

Global biopharma companies are looking to capitalize on value creation across different geographic regions through utilization of novel technologies, leveraging skilled resources to develop novel therapies at optimal development cost and time, to meet the global clinical needs.

Chinese biopharma companies can enter developed markets in the US and Europe through strategic partnerships or by setting-up their own operations in these markets. China recorded the largest number of new trials during the analysis period between 2017-2021 with the number of new trials doubling during this period. The United States Food and Drug Administration (USFDA) does consider overseas trials data for new drug applications (NDA) as long as certain conditions are met. However, a bridging study is required in many cases, where trials have been conducted in ex-US countries. The USFDA filings by Chinese companies using overseas (ex-US) clinical trials data have increased in recent years, especially for oncology drugs. The USFDA’s clinical development regulations present several benefits to Chinese companies including investment opportunities, development partnerships, strategic alliances with global companies and streamlined regulatory processes.

In recent years, the USFDA has approved several compounds developed by Chinese companies based on results from trials conducted in China or other ex-US locations. However, the USFDA is of the opinion that for drugs tested only in one country, such as China, it is difficult to generalize the study results from overseas trials to the US population due to differences in the patients' ethnicity and so require additional clinical trials that reflect the US patients. Therefore, Chinese companies should engage with the USFDA early and formally to work out these nuances to gain guidance upfront to get their drugs approved in the US.