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Closed-Loop Inspections? Strict COVID Zero Policy Delays FDA's China Field Trips

 
• By Dexter Jie Yan

Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a "quarantine bubble" like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.

approval delays
• Source: Shutterstock

With the Chinese government showing few signs of lifting stringent restrictions on international travel, the country’s drug makers are increasingly bearing the brunt of overseas approval delays due to the requirement to receive on-site facility inspections from foreign regulators including the US Food and Drug Administration.

The newest entrant to this growing list might be BeiGene, Ltd. The Beijing-based biotech is anticipating an FDA decision...

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More from Focus On Asia

BeBetter, Trinomab Advance IPOs On China’s STAR Market In Firsts Since Policy Easing

 
• By Dexter Jie Yan

BeBetter becomes first unprofitable innovative drug maker to have application for an IPO on Shanghai's STAR Market cleared by China’s top securities regulator, while Trinomab becomes first among peers to have IPO filing accepted.

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• By Vibha Ravi

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Sumitomo Parkinson’s Filing A Pivotal Moment For Japan’s iPSC Ambitions

 
• By Lisa Takagi

Sumitomo Pharma's iPSC therapy for Parkinson's has been filed for approval in Japan after showing safety and efficacy in a Phase I/II trial and may become one of the first such therapies to reach the market in the country, which has invested heavily in the modality.