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.

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.

Junshi’s oral antiviral shows signs of effectiveness in treating patients with mild COVID-19 symptoms but more data are needed, caution researchers.

Chinese drug makers have more to lament and plenty to learn from as Junshi, HutchMed follow Innovent Bio with FDA rejections. A holistic not opportunistic approach is needed, one ex-FDA expert suggests.