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    Home > Active Ingredient News > Drugs Articles > Clinical trial of the novel coronavirus pneumonia injection BDB-001 for the treatment of new crown pneumonia is approved by the ethics committee.

    Clinical trial of the novel coronavirus pneumonia injection BDB-001 for the treatment of new crown pneumonia is approved by the ethics committee.

    • Last Update: 2020-02-21
    • Source: Internet
    • Author: User
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    In February 21st, the novel coronavirus pneumonia, which was developed by the company and its wholly-owned subsidiary, de Fung Rui, was approved by the ethics committee of the third people's Hospital of Hainan province The Ib phase trial, which was developed by the company and its wholly-owned subsidiary, has completed the preparatory work and is about to launch the above clinical trials The data shows that in the studies of H1N1 infected mice, H5N1 infected mice and h7n9 infected African green monkeys, it is found that the complement system is over activated, which is specifically manifested in the deposition of C3, C5a, C5b-9, MBL-C and the upregulation of MASP2, c3ar and C5aR in the lung A large amount of C5a is produced, which makes the polymorphonuclear leukocytes represented by neutrophils chemotactic to the lung C5a concentration increased rapidly in the lung and formed a positive circulatory cascade reaction, leading to cytokine storm, which eventually developed into severe pneumonia and acute respiratory distress syndrome, endangering the life of patients Using anti C5a antibody to inhibit the activation of complement system can effectively reduce the acute lung injury caused by H5N1 and h7n9, suggesting that inhibiting C5a activity is a feasible scheme for the treatment of lung injury caused by over activation of complement In the past 30 years, more than 4000 PubMed research reports have suggested that C5a is the strongest factor in the early stage of acute infection and tissue injury inflammation It is recognized as a broad-spectrum inflammatory amplifier, the main effector of complement over activation leading to acute inflammatory response, and the ideal target of emergency medicine for infection and injury Bdb-001 injection is a monoclonal antibody drug for human C5a, which can specifically bind C5a and make C5a lose the ability of binding receptor, thus blocking its induced biological functions, such as neutrophil chemotaxis, release of lysozyme in cells, increase of inflammatory cytokines level and oxygen respiratory burst, etc., inhibiting the inflammatory cascade reaction, so as to control the further development of inflammation without inhibiting it Immune function Previously, bdb-001 injection was approved in the clinical trial in July 2018 to carry out the clinical study on the indications of moderate and severe pyogenic sweat adenitis At present, bdb-001 injection is in phase I clinical research, no obvious adverse reactions are found in the healthy subjects who have been enrolled, and the safety is good Novel coronavirus infection novel coronavirus infection is the two indication of BDB-001 injection: (1) reduce the incidence of severe pneumonia and reduce the incidence of acute respiratory distress syndrome (SARS) for new coronavirus infection; (2) treatment of severe pneumonia caused by new coronavirus infection Whether the follow-up clinical trials of these two indications can be carried out in an orderly manner, whether they can obtain the production approval of the State Drug Administration and whether they can be approved for marketing remains uncertain The company said it would continue to push forward the next step of the above projects.
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