China-US Health Regulatory Dialogue In Crosshairs Amid Biden-Xi Summit
PIC/S Membership Meets Political Pressure
Beijing’s application to join an international pharma inspections scheme offers a rare opportunity to revitalize a largely downsized US-China dialogue, but domestic pressure and public opinion may jeopardize the opportunity.
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Topics in this latest Chinese-language podcast include the US approval of Chinese innovative drugs including Junshi’s anti-PD-1 antibody toripalimab, Sanofi’s deal with BioMap for AI-powered drug discovery, Chinese companies' third-quarter results and the Biden-Xi summit on the sidelines of APEC and its implications for bilateral regulatory dialog.
At least one major Chinese supplier is being tapped to relieve a shortage of certain drugs in the US despite rising Beijing-Washington tensions, but China may be increasingly unwilling to co-operate amid its own shifting economic priorities, increasingly introspective policies and some shortages of its own.
Amid deepening bilateral decoupling and geopolitical tensions, the US regulatory agency is sending field inspectors to China for the first time in three years as it moves forward in reviewing and potentially approving the first 'Made In China' immuno-oncology drugs.