On November 29, Huabei Pharmaceutical announced that the subsidiary's new drug company had received the “Clinical Trial Notice†issued by the State Food and Drug Administration and agreed to “recombinant human anti-rabies virus monoclonal antibody NM57S/NC08 injection combination preparationâ€. In early clinical trials. This product is used in combination with human rabies vaccine for passive immunization of patients who are bitten by rabies or other rabies virus susceptible animals.
For the "rabies virus", I am sure that everyone is no stranger. According to published information, rabies virus is a neurotropic virus. When a person is bitten by an animal with rabies virus in his saliva, the time it takes for the virus to reach the nerve center usually ranges from 5 days to a few years. Being bitten by a pet, it is generally necessary to take the rabies vaccine as soon as possible to the health and epidemic prevention department. For severe bites, in addition to thorough cleaning and disinfection, rabies serum infiltration should be applied around the wound, followed by rabies vaccine.
At present, with the development of domestic living standards, there are more and more families of pets, and the demand for rabies vaccines is also expanding. Previously, vaccine safety issues have caused intense social discussion, and people are more focused on requiring safety and effectiveness.
It is understood that the rabies virus itself does not mutate, but in theory it is not impossible. According to North China Pharmaceuticals, the recombinant human anti-rabies virus monoclonal antibody injection approved for early clinical trials is a single antibody injection that acts on a conserved site on the surface of rabies virus for neutralizing rabies. poison. In other words, this injection can prevent the rabies virus from mutating to a certain extent, which is also a breakthrough in the industry.
It is reported that the monoclonal antibody combination preparation declared by North China Pharmaceuticals is a combination preparation of NM57S and NC08 two monoclonal antibodies, and its mechanism of action is the same as that of recombinant human anti-rabies virus monoclonal antibody injection, which can be combined with rabies vaccine. To passive immunity.
According to the company's relevant data, as of the end of October 2018, North China Pharmaceutical's research and development investment in the recombinant human anti-rabies virus monoclonal antibody NM57S/NC08 injection preparation project has reached 7,753,600 yuan. In addition, during the period from 2014 to 2016, the company received a total of 5.129 million yuan of financial subsidy funds for the project.
According to North China Pharmaceutical, the passive immunoassays currently available for post-exposure detection of rabies virus in the country are anti-rabies serum and rabies immunoglobulin. According to the background check of the State Food and Drug Administration, the author has 34 domestically produced drugs for rabies patients with immunoglobulins and 0 for imported drugs. There are 6 domestically produced drugs for anti-rabies serum and 0 imported drugs.
At present, it is not possible to find domestic market sales data on recombinant anti-rabies virus monoclonal antibody injection. In foreign countries, the recombinant anti-rabies virus monoclonal antibody injection developed by the Indian Institute of Serology was approved for marketing in India in December 2016; Phase II clinical trials have been completed by Crucell in the Netherlands and Zydus Research Center in India.
According to the laws and regulations related to drug registration in China, “recombinant human anti-rabies virus monoclonal antibody NM57S/NC08 injection combination preparation†is still required to carry out clinical trials and be reviewed and approved by the State Food and Drug Administration after obtaining the clinical trial notice. It can be produced at the rear.
It is reported that the recombinant human anti-rabies virus monoclonal antibody injection developed by the new drug company is currently conducting phase III clinical trial research.
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