The Biotechnology Innovation Organization (BIO), a US industry trade group, has completed a survey among its members to gauge dependence on Chinese service providers in the life sciences industry. The results, reported by FiercePharma.com, are intended to guide US lawmakers as they prepare to potentially finalize the BioSecurity Act next week.
The survey revealed that out of 133 respondents representing 124 companies, the majority were from smaller biotech firms with less than 250 employees, while approximately 19% were from larger companies employing over 1,000 staff. A staggering 79% indicated that their companies have at least one contract or product supported by a Chinese Contract Development and Manufacturing Organization (CDMO), with around 9% having at least 25 such contracts. Services encompass manufacturing scales from preclinical to commercial, including molecule and protein development, raw materials procurement, toxicology assessment, and cell-line growth.
According to the survey, 85% of respondents believe that changing vendors for preclinical and clinical work would take between 6 months to 6 years, and 52% said switching manufacturers for commercial-stage products would require 2 to 8 years.
Respondents also noted that the imposition of the BioSecurity Act could lead to a rapid increase in pressure and costs on related services and regulators if it forces a switch of vendors.
When asked about the potential impact on patients due to a disruption in services provided by Chinese CDMOs for approved medicines, approximately 18% estimated at least 500,000 patients would be affected, while 20% expected the number to be between 100,000 and 500,000. About 16% of respondents were focused solely on rare diseases.
The findings are likely to be closely watched by companies like WuXi AppTec, which was named in draft versions of the BioSecurity Bill and recommended for blacklisting over security and intellectual property concerns. The final wording of the bill is scheduled to be concluded by May 15, 2024.- Flcube.com
