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At the 2024 DJS Innovation Collaboration Summit, Michael Borden, Partner at Sidley Austin, will share a keynote speech on "U.S. Regulatory Resistance to Chinese Biotech Companies" on the first day of the conference.
Written by | Chen Xiaojuan
ON MAY 9, THE HOUSE VERSION OF THE BIOSECURE BILL WAS AMENDED. In addition to adding WuXi Biologics to the list of "biologics of concern," the new bill also sets a deadline of January 1, 2032 for the U.S. biologics industry to decouple from companies such as WuXi AppTec and WuXi Biologics. The House Oversight Committee is expected to consider the bill on May 15.
SCREENSHOT SOURCE: REVISED VERSION OF THE BIOSECURE ACT
The proposed deadline for the bill matches the timeline set out in a recent investigation report by the U.S. biotechnology organization BIO.
According to the survey report released by BIO on May 6, among the 134 respondents representing 124 biopharmaceutical companies, 52% said that for approved drugs, it may take 2~8 years to replace alternative contract service providers; For preclinical and clinical work, 85% said that it may take 6 months ~ 6 years to change suppliers.
Screenshot source: BIO investigation report
It also illustrates that cutting Chinese CDMOs from the U.S. drug supply chain will be a long process.
In the BIO report, 79% of people said they had at least one contract or product supported by a Chinese CDMO. Respondents cited the difficulty of finding alternative service providers, the need for commissioning and validation, the need to work with regulators, and increased costs as potential pain points for switching vendors.
Edit | Dai Jialing [email protected]
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