Industry Focus
Chinese Biotech In the Spotlight
Over the last decade, small, medium-sized, and even large biopharmaceutical companies have come to rely on inexpensive manufacturing and nonclinical product development support from Chinese organizations. However, since COVID, this offshoring approach to save time and money has received greater scrutiny. From US government sources (including FDA) to industry working groups (e.g., Bio), to major political news outlets, it seems that everyone is talking about the limitations and risks of developing and manufacturing products in China. National security concerns top the list, including risks associated with arming the Chinese government with genetic and health information of Americans. However, issues around IP protection, mandatory sharing of technology with the Chinese government, and even IP theft have many companies shying away from development in China. Finally, data quality and data integrity issues have led Sponsors to have to re-run nonclinical and clinical studies to satisfy FDA requirements. We have been asked by many of our clients whether they should be concerned about offshoring CMC support and nonclinical studies (including planned, ongoing, or recently completed studies with WuXi) to China. Sociopolitical and IP issues aside, Facet experts have seen FDA readily accept CMC, nonclinical, and clinical data generated by Chinese organizations (including WuXi) to support INDs and marketing applications (NDAs and BLAs). In line with Facet’s counsel to our customers, we expect that FDA will continue to accept data from Chinese organizations (and really any third party, regardless of geographic location) as long as Sponsors carefully oversee third party support and ensure that what is provided complies with global and local (FDA) regulations and guidances.