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Pfizer Inc.'s PD-1 inhibitor PF-06801591 injection has been approved in a clinical trial in China for "high-risk non-muscle-immersive bladder cancer," according to a new announcement on the website of the Drug Review Center (CDE) of china's State Drug Administration.
, PF-06801591 has entered phase 3 clinical development, the first time the drug has been approved clinically in China.
it is worth noting that most of the PD-1/PD-L1 inhibitors currently approved are intravenous, and one of the unique features of Pfizer's PF-06801591 is that they can be injected under the skin.
photo source: CDE Screenshot PF-06801591 is a human immunoglobulin G4 (IgG4) monoclonal antibody developed by Pfizer.
, as a PD-1 inhibitor, blocks its interaction with PD-L1 and PD-L2 on cancer cells by binding to PD-1 on T cells, allowing T cells to locate cancer cells and destroy them.
in-body studies, PF-06801591 has shown the role of inducing T-cell proliferation and inflammatory cytokine secretion in human-activated CD8-T cells.
, PF-06801591 has not been approved for listing in any country or region, and has entered phase 3 clinical phase worldwide.
this is the first time the drug has been approved clinically in China, to develop treatment "high-risk non-muscle immersion bladder cancer."
is conducting eight clinical trials of PF-06801591 involving a variety of indications, including non-small cell lung cancer (NSCLC), bladder cancer, and melanoma, according to the website Clinicaltrials.gov.
this includes a randomized, open, three-arm parallel multi-center Phase 3 clinical trial aimed at comparing the efficacy of PF-06801591 combined card-mediated seedling (BCG) in high-risk non-muscular immersive bladder cancer.
Although several PD-1/PD-L1 inhibitors have been approved worldwide, most of them are administered intravenously, which is not very convenient for patients, and insulation PD-1/PD-L1 antibodies are expected to address this inconvenience.
, the PF-06801591 injection method has shown initial efficacy in the study.
based on data published by researchers in June 2019 in JAMA Oncology, Pfizer's PD-1 inhibitor PF-06801591 achieved good results in an open, multi-center Phase 1 dose increment study.
results showed that intravenous and insulated dose levels of PF-06801591 showed anti-tumor activity in different types of tumors;
paper points out that PF-06801591 is a convenient and effective alternative to existing intravenous immuno-checkpoint inhibitors.
Reference Center of the State Drug Administration of China. Retrieved Aug 11, 2020, from Johnson, M. L., Braiteh, F., et al. (2019). Assessment of Subcutaneous vs Intravenous Administration of Anti-PD-1 AntibodyPF-06801591 in Patients With Advanced Solid Tumors. JAMA Oncology.doi: 10.1001/jamaoncol.2019.0836 . Retrieved Aug 11, 2020, From.