China’s CDE clarifies NDA dossier requirements

A wave of PD-1/PD-L1 mAb application pushes CDE to act

The CFDA's Center for Drug Evaluation (CDE) released a guidance document setting out basic requirements for New Drug Application (NDA) filings in relation to programmed death-1/ligand-1 (PD-1/PD-L1) monoclonal antibody (mAb) products. A wave of 16 PD-1/L1 candidates are currently under clinical development for the China market, with NDA filings in recent weeks for Bristol-Myers Squibb’s nivolumab, Innovent Biologics’ sintilimab, and Merck, Sharp & Dohme’s pembrolizumab.

The CDE drew up the guidance on the basis of a recent industry seminar, and the rules indicate a cautious approach will be taken. At least two independent assessments of safety and efficacy data for all patients enrolled in the study should be included in the initial dossier. Rolling submissions of data will be employed during NDA review, with at least 6 months’ efficacy and safety data for each subject in the trial required before an approval.

Source: GBI (

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