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On November 25, 2004, the State Food and Drug Administration officially approved the compound AIDS vaccine developed by the researchers of Changchun Baike Pharmaceutical Co., Ltd. to enter the Phase I clinical study. This is the first clinical trial of AIDS vaccine in China, marking The research on AIDS vaccine in China is synchronized with the international one; the phase I clinical study of AIDS vaccine mainly evaluates the safety of vaccine, and the State Food and Drug Administration will consider whether to approve Phase II and Phase III clinical studies based on the results of Phase I.
Since 1996, Chinese scientists and technicians have used Chinese popular HIV strain genes, including viral envelope proteins and core proteins, for 8 years. The vaccine consists of a DNA vaccine and a recombinant viral vector vaccine, which is first inoculated with a DAN vaccine, and then inoculated with a recombinant viral vector vaccine to produce immunity against AIDS. The vaccine itself does not cause infection after vaccination. The vaccine passed the monkey test and after the virus attack, the animals showed no abnormalities. At present, more than 30 international scientific research institutions have conducted clinical trials in 19 countries, and most of them are in Phase I clinical research.
In the fight against AIDS, scientists have developed some drugs that can inhibit HIV, but even the best-recognized cocktail therapy can only stabilize or slow down the symptoms of AIDS, and can not completely eliminate the virus in the body. Experts generally believe that the development The AIDS vaccine is the fundamental way to solve this social problem.
In line with the country's need for major disease prevention and control, the State Food and Drug Administration continues to maintain early intervention and fast-track mechanisms for drug review such as SARS and AIDS, and implements “standards are not reduced, help improve; procedures are not reduced, and approval is accelerated. The work guidelines have accelerated the progress of these drugs into clinical trials and will continue to advance the research in the future.