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

The reellizhu mono-anti-injection is a human-derived lgG4 anti-procedural death receptor 1 (PD-1) monoclonal antibody designed to minimize binding to fc-sillinR receptors in macrophages.
currently, there are 16 registered clinical trials in China and around the world, including 12 Phase 3 clinical trials and four critical Phase 2 clinical trials.
According to the Baiji Shenzhou announcement, the registration of reliance in China is as follows: In December 2019, the drug was approved by NMPA for the first time for the treatment of patients with recurrent or refractive classic Hodgkin lymphoma who have undergone at least second-line system chemotherapy, and the product is called Baizean.
April 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 received platinum-containing chemotherapy failures including progression of new or auxiliary chemotherapy within 12 months.
the UC in this approval is the second indication that Bezean has approved.
April 21, 2020, NMPA accepted a new application for new indications for the treatment of patients with first-line advanced squamous non-small cell lung cancer.
this is the third sNDA to be declared in China for the drug.
June 19, 2020, NMPA accepted a new application for admission to the market for patients with advanced non-scaly non-small cell lung cancer in the first line.
this is the second sNDA submitted in China for the first-tier late-stage NSCLC, which is expected to be The Fourth Indications of Bacsatin in China.
June 29, 2020, NMPA accepted the drug's fifth sNDA.
In addition to the above-mentioned declared or approved indications, the drug is being conducted in the third phase of clinical research on cancer species: liver cell carcinoma, extensive small cell lung cancer, esophageal squamous cell carcinoma, stomach cancer and nasopharyngeal cancer.
therefore, the fifth listing application was submitted at CDE for the reilly bead sing-it-one injection, which may be one of the five cancers that have progressed to the late clinical stage.
congratulates 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.
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