Akeso Biopharma Co., Ltd.: AK105

We acknowledge receipt of your major amendment dated June 14, 2022, which extended the goal date by three months.

We also refer to the general advice letter, issued October 14, 2022, notifying you that the extended PDUFA date of October 16, 2022, would be missed due to travel restrictions preventing the inspection of Akeso Biopharma Co., Ltd.

Reference is made to information provided in the original submission and in response to the Agency's IRs dated April 12, 2022, and August 18, 2022. The totality of information and data provided is inadequate to support the suitability of the following quality control methods for their intended use:

Satisfactory responses to these deficiencies should be provided by the facility to the email address provided on the 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 the complete response and may require re-inspection of the facility.