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    Home > Active Ingredient News > Antitumor Therapy > Application for a new drug for the treatment of hepatocellular carcinoma in PD-1 monoanti-Tisleizumab in Baiji Shenzhou was accepted by NMPA, as well as a summary of Tislelizumab clinical studies

    Application for a new drug for the treatment of hepatocellular carcinoma in PD-1 monoanti-Tisleizumab in Baiji Shenzhou was accepted by NMPA, as well as a summary of Tislelizumab clinical studies

    • Last Update: 2020-07-14
    • Source: Internet
    • Author: User
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    Baiji Shenzhou announced that China's National Drug SupervisionManagementBureau (NMPA) Drug Evaluation Center (CDE) has accepted Baiji Shenzhou's anti-PD-1 monoanti-retinzumab supplementation drug application (sNDA) for previously treated non-removable hepatocellular cancer (HCC) (the most common form of liver cancer) patientsDrWu Xiaobin, General Manager of China and President of Baiji Shenzhou, said, "We are very excited that the first application for liver cancer in reliion is acceptedHalf of the world's liver cancer patients live in China, and medical needs remain unmetWe will continue to maintain contact with CDE and hope to provide these patients with viable treatment options in the near futureapplication for sNDA is based on support of the results of Phase 2 clinical trials (NCT03419897) in patients previously treated with non-removable HCCThe study recruited 249 non-removable HCC patients from eight countries and regions in Asia and Europe who received tislelizumab single drug therapy (200 mg every three weeks)The main endpoint of the trial is the objective mitigation rate assessed by the Independent Audit Committee (IRC) and the results will be presented at the upcoming medical conferencethetislelizumab (BGB-A317) is a human-derived IgG4 anti-PD-1 monoclonal antibody designed to minimize binding to Fc-R on macrophagesIn preclinical studies, it has been shown that binding to Fc-R on macrophages activates antibody-dependent macrophage-mediated T-effect cell killing, thereby impairing the anti-tumor activity of PD-1 antibodiesTislelizumab has been approved by the State Drug Administration of China (NMPA) for patients with classic Hodgkinlymphomawho have received at least two previous treatments, as well as patients with local advanced or metastatic urethopathic dermatomy (UC) patients with high expression PD-L1, during or after platinum chemotherapy, or within 12 months of new or platinum-assisted chemotherapy-assisted therapy clinical trials of reilly bead monotorthsis include: phase 3 trial for the treatment of locally advanced or metastatic urethra skin cancer patients in the (NCT03967977); compared to reilly beads monotherapy and Dositasas as NSCLC second- or third-line treatment of the 3-phase trial (NCT0333333) 58875); 3-phase trial of reilly zumas as a first-line treatment of patients with advanced squamous NSCLC (NCT03594747); 3-phase trial of reilly zumas as first-line treatment for advanced non-small cell lung cancer (NCT03663205); Tri-relizumab combined platinum-type chemotherapy as a new auxiliary treatment for NSCLC patients 3-phase trial (NCT04379635); 3-phase trial for relyllibead monoantiapizumab and optoside treatment for patients with extensive small cell lung cancer (NCTT4005716); compare the terreizumab and Soranoni as a third-line cell treatment of hepatocancer (HCC); NCT03412773); for stage 2 clinical trials (NCT03419897); compared triarlistitis and chemotherapy as a second-line treatment of endoesophageal squamous cell carcinoma (ESCC; NCT03430843); 3-phase trial for the first-line treatment of ESCC reilly beads as a first-line treatment (NCT03783442); 3-phase trial of local ESCC (NCT03957590) in combination treatment of local ESCC for reilly-beads monostatinal resistance and radiation chemotherapy; the stage 3 trial of the first-line treatment of gastric cancer patients (NCT03777657); 2-phase trial (NCT03736889) in patients with MSI-H/dMMR monotomatherapy; a phase 3 trial (NCT03924986) for relynasstomy monoto-anti-combination chemotherapy as a first-line treatment for nasopharyngeal cancer patients
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