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BeiGene/Novartis's Tislelizumab Faces US Delay Over China Inspection Challenges

No Timetable in Sight

 
• By Brian Yang

An inability to conduct manufacturing field inspections in China due to strict local COVID-19 policies is cited as the only reason for the delay for the anti-PD-1 drug, for which the timescale for resolution is currently unclear.

CHINA ZERO COVID DETERS FDA INSPECTIONS TO THE COUNTRY
BEIGENE/NOVARTIS PD-1 AGENT FACES FDA APPROVAL DELAY DUE TO CHINA'S 'COVID ZERO' POLICIES • Source: Shutterstock

China’s strict "COVID Zero" policies appear to be complicating otherwise straightforward processes related to new drug approvals in the US, in the latest case causing a delay due to an inability to conduct related field inspections in the country.

BeiGene, Ltd. has seen a potential US approval for its immuno-oncology agent tislielizumab, which is partnered with Novartis AG for this market, postponed by the US Food and Drug Administration

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