Approval for clinical trial of Baiji Shenzhou PD-1 McAb bgb-a317

Today (September 12), after "Baiji Shenzhou anticancer drug bgb-290 obtained the drug clinical trial approval issued by CFDA", Baiji Shenzhou announced that the PD-1 McAb bgb-a317 for the treatment of advanced solid tumors has obtained the drug clinical trial approval issued by CFDA, and China has become the first bgb-a317 to obtain the clinical trial approval after Australia, New Zealand, the United States and Taiwan Fifth region It is reported that bgb-a317 is a humanized monoclonal antibody in the clinical trial stage, which belongs to a new tumor immune agent called "immune checkpoint" inhibitor The mechanism of bgb-a317 is to bind to PD-1 receptor on the cell surface, which is an important immunosuppressive molecule It can inhibit the activation of T cells, thus reducing the role of the immune system Bgb-a317 has a high affinity and specificity for PD-1, and its binding ability to FC γ receptor I has been specifically removed by bioengineering technology Bgb-a317 is being developed as a single therapy and a combination of other therapies for various cancers At present, more than 200 patients have been enrolled in bgb-a317 single drug clinical trials overseas, focusing on safety, tolerance, pharmacokinetics and antitumor activity for 26 different tumor types The preliminary results of phase I clinical trials are published in ASCO this year Aurejo, one of the founders, chief executive officer and chairman of Baji Shenzhou, said: "the clinical trial approval of BGB-A317 means that the products under research in 4 clinical stages of Baji Shenzhou can be carried out clinical trials in China The sustained and steady growth of domestic pharmaceutical market is crucial to the development of Baiji Shenzhou We are very pleased to receive this approval and look forward to officially launching clinical trials of bgb-a317 in mainland China, while continuously promoting global clinical development of bgb-a317 and providing the latest clinical data " Yan Xiaojun, head of Baiji Shenzhou pharmaceutical affairs, said: "bgb-a317 is an innovative biological drug independently developed in China In the overseas phase I clinical dose increasing test, we have accumulated safety and effectiveness data for patients with advanced solid tumors, which provides a good support for bgb-a317 to obtain the approval of clinical trials in Mainland China We will continue to keep close communication with CFDA to promote the development process of bgb-a317 in China "