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Shutaishen submitted a clinical trial application for the treatment of severe pneumonia

category:Global
 Shutaishen submitted a clinical trial application for the treatment of severe pneumonia


The indications of bdb-001 injection are that the complement system can be specifically activated by coronavirus, the inflammatory reaction caused by the activation of complement system caused by virus and other factors can be inhibited, and it can be used for the treatment of severe pneumonia caused by coronavirus.

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, and it is recognized as a broad-spectrum inflammatory amplifier, the main effector of over activation of complement leading to acute inflammatory response, and the ideal target of infection and injury emergency medicine.

Bdb-001 injection is a monoclonal antibody drug for human C5a molecule developed by Germany infrarx company, a wholly-owned subsidiary of shutaishen, which is authorized by dferry. It can specifically bind C5a, making C5a lose the ability of binding receptor, thus blocking its induced biological functions, such as neutrophil chemotaxis, intracellular lysozyme release, inflammatory cytokine level rise and oxygen respiratory burst In order to control the further development of inflammation, it does not inhibit the immune function. At the same time, it does not affect the formation of C5 cleavage and membrane attack complex (MAC), and retains the bacteriolysis mediated by complement, which can prevent the severe pneumonia in coronavirus infection and reduce the incidence of severe pneumonia and acute respiratory distress syndrome.

Shutaishen disclosed that on February 7, 2018, bdb-001 injection was accepted by the clinical trial application of the former State Food and Drug Administration for the treatment of moderate and severe suppurative sweat gland inflammation; in July 2018, it was approved to carry out the clinical study of the above indications. At present, bdb-001 injection is carrying out phase I clinical research, no obvious adverse reactions are found in the healthy subjects who have been enrolled, and the safety is good.

Wang Wei, director of the Department of science and technology of Hubei Province, said that Hubei Province has made relevant progress in tackling scientific and technological problems in diagnosis and treatment of drugs. Among them, the Central South Hospital of Wuhan University improved the method of nucleic acid extraction, which doubled the speed of diagnosis results, and the results of nucleic acid detection can be obtained as soon as 2 hours.