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    Home > Medical News > Latest Medical News > Kangfang Bio/Zhengda Tianqing PD-1 first-line squamous NSCLC phase III clinical trial reached the primary endpoint

    Kangfang Bio/Zhengda Tianqing PD-1 first-line squamous NSCLC phase III clinical trial reached the primary endpoint

    • Last Update: 2021-03-24
    • Source: Internet
    • Author: User
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    On February 24, Kangfang Biological and Sino Biopharmaceutical jointly announced that their jointly developed anti-PD-1 monoclonal antibody "Paimrizumab" combined with chemotherapy for the first-line treatment of advanced/metastatic squamous non-small cell lung cancer (NSCLC) The phase III clinical interim analysis reached the main research endpoint, and plans to communicate with CDE to submit the listing application.


    This interim analysis showed that Paclitaxel combined with paclitaxel and carboplatin compared to placebo combined with paclitaxel and carboplatin can significantly reduce the risk of disease progression or death, and the main research endpoints have reached the superiority threshold of the program, and the safety is The characteristics are consistent with the results of the previously reported studies of Pianpulizumab, and there are no new safety issues.


    Paimrizumab (R&D code: AK105) is a PD-1 monoclonal antibody jointly developed and commercialized by Kangfang Biological and Chia Tai Tianqing.


    According to the Insight database, the new drug listing application for Paimrizumab for the treatment of relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) after at least second-line chemotherapy has been approved by CDE on May 28, 2020 Undertake.


    In addition, according to the Insight database, the indications that Peamprizumab is looking at include non-squamous NSCLC (first-line), nasopharyngeal carcinoma (first-line), and hepatocellular carcinoma (first-line).


    From the Insight database (http://db.


    According to WHO data, lung cancer is the disease with the highest incidence in China in 2020, and 90% of lung cancers belong to non-small cell lung cancer.


    According to the Insight database, PD-1 currently approved for listing in China is widely deployed in the first-line to second-line treatment of non-small cell fields, and competition is fierce.


    Domestic PD-1 non-small cell lung cancer indications layout

    In addition, in addition to lung cancer indications, domestic PD-1 also has a wide range of cancer types, including nasopharyngeal cancer, urothelial cancer, liver cancer, gastric cancer, esophageal cancer and other cancer types.


    The second-line liver cancer Hengrui has been approved.


    For gastric cancer indications, currently only Bristol-Myers O-drug has been approved for third-line treatment in China, and the rest have not yet been declared by enterprises.


    List of domestic companies' PD-1 indications and expected approval time

    Data source: Insight database (https://db.


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