NMPA CDE Announcement on Issuing the Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Bloc

In order to further guide enterprises to optimize the clinical dosage of PD-1 /PD-L1 antibodies and improve patient compliance and overall quality of life, provide a technical specification that can be referred to, CDE has organized to formulate the Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer , which was issued and implemented on January 10, 2024 upon the review and approval of the NMPA.