Baiji Shenzhou PD-1 for the Leili Zhu singular resistance to the 5th indication list application was accepted.

Today, China's National Drug Administration (NMPA) Drug Review Center (CDE) recently announced that the new PD-1 antibody drug under Baiji Shenzhou submitted a new indication-it-up (sNDA) application for the reilly bead sing-it-up injection, and received itThe fifth application for a listed application in China for reliance-beaded monoto-injectable sein is previously approved in China for Hodgkin's lymphoma and urinary skin cancer, and its first for non-small cell lung cancer (NSCLC) was filed in AprilA week ago, the drug's second sNDA for first-line NSCLC patients was admitted to CDEthirelizumab injection is a human-derived lgG4 anti-procedural death receptor 1 (PD-1) monoclonal antibody designed to minimize binding to fc-sillinR receptors in macrophagesCurrently, there are 16 registered clinical trials in China and around the world, including 12 Phase 3 clinical trials and four critical Phase 2 clinical trialsAccording to the Baiji Shenzhou announcement, the registration progress of reliever in China is as follows:December 2019, the drug was approved by NMPA for the first time to treat patients with recurrent or refractive classic Hodgkin lymphoma who have undergone at least second-line system chemotherapy, and the product is called BaizeanApril 11, 2020, the drug was approved for the treatment of patients with locally advanced or metastatic PD-L1 highly expressed urinary skin cancer (UC) who failed to receive platinum-containing chemotherapy, including progression of new or auxiliary chemotherapy within 12 monthsThe UC in this approval is the second indication that Bezean has been approvedApril 21, 2020, NMPA accepted a new application for admission to the market for bacauth sacin to treat patients with first-line late-stage squamous non-small cell lung cancerThis is the third sNDA declared by the drug in ChinaJune 19, 2020, NMPA accepted a new application for new indications for the treatment of patients with first-line non-scaly non-small cell lung cancerThis is the second sNDA for the first-tier late-stage NSCLC in China, which is expected to be The Fourth Indications of Baxter in ChinaJune 29, 2020, NMPA accepted the drug's fifth sNDAin addition to the above-mentioned declared or approved indications, the drug is being conducted in phase 3 clinical studies on cancer species: liver cell carcinoma, extensive small cell lung cancer, esophageal squamous cell carcinoma, stomach cancer and nasopharyngeal cancerAs a result, the fifth listing application was submitted at CDE for the Reilly-beaded monoto-injection, which may be one of the five cancers that have progressed to the late-clinical stagescongratulates Baiji Shenzhou on submitting another listing application for reliion-beaded monoto-injection, hoping that the product's clinical research and registration declaration will go smoothly and benefit more patients as soon as possible .