Checkpoint Therapeutics, Incorporated: cosibelimab

Please refer to your biologics license application (BLA) dated January 3, 2023, submitted under section 351(a) of the Public Health Service Act for cosibelimab (CK301).

Korea (FEI 3010479596), for the drug substance and drug product manufacturing acility listed in this application, FDA conveyed deficiencies to the representative of the facility.

FDA has reviewed the responses from the facility, and not all deficiencies have been satisfactorily resolved.

Satisfactory responses to these deficiencies should be provided by the facility to the email address provided on he Form FDA 483 Inspectional Observations, prior to submitting your complete response.

Your complete response should include the date of the facility's response to the Post-action Letter.

The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of he complete response and may require re-inspection of the facility.

2. Following evaluation of the inspection findings noted above, and the response to hose findings, FDA has identified concerns regarding the reliability of data generated at Samsung Biologics in your BLA submission.

Therefore, the adequacy of the proposed cosibelimab manufacturing process and overall control strategy cannot be determined at this time to support the licensure of cosibelimab.