NEWS
The first in the country! Aimei Vaccine's human rabies mRNA vaccine clinical application has been accepted
Aimei Vaccine (06660) announced on the 12th that the clinical trial application for human rabies mRNA vaccine under research has been accepted by the CDE. This is the first domestic application for a clinical rabies mRNA vaccine.
Compared to traditional human rabies vaccines, the mRNA rabies vaccine has the following advantages: higher immunogenicity; requires fewer doses to achieve immunity (two or three doses) compared to traditional vaccines (four or five doses), with a simpler dosing regimen; production does not involve complex cell culture processes, making it easier to produce; fewer impurities from raw materials, making purification easier; higher batch-to-batch consistency in quality; and potentially offering greater safety by reducing the associated risks of injecting inactivated viruses or foreign cells into the body.
According to a research paper published in the "Virology Journal," animal experimental data shows that the Aimei vaccine's mRNA rabies vaccine under research provides immunity against the rabies virus with just two doses, effectively induces antibody production, and stimulates cellular immune responses. The highest level of immune protection is observed when administered to mice with a 14-day interval between doses. Additionally, this vaccine has been verified for both prevention and treatment of rabies virus, as beagle dogs vaccinated with it can generate protective antibody levels and display a 100% survival rate three months after infection.
Aimei Vaccine is the world's second-largest rabies vaccine manufacturer. Its Vero cell freeze-dried human rabies vaccine has maintained a 100% pass rate in the quality review of batch issuance by the China Institute of Food and Drug Control for 15 consecutive years, setting the longest record among all human rabies vaccine suppliers in China, with a cumulative batch issuance exceeding 100 million doses.
In Aimei Vaccine's current R&D pipeline layout, the rabies vaccine has a complete iterative upgrade plan and design. Based on the existing classic product, the Vero cell freeze-dried human rabies vaccine, there will be three iteratively upgraded rabies vaccines rapidly entering R&D, including the serum-free Vero cell rabies vaccine already approved for clinical use, the human diploid cell rabies vaccine, and the mRNA rabies vaccine. The mRNA rabies vaccine is an important upgraded iterative product.
Aimei Vaccine possesses an independent mRNA production and drug delivery technology platform, having applied for multiple invention patents in drug design, production, and formulation delivery. It is also one of the first domestic enterprises to obtain clinical approval for mRNA COVID-19 vaccines.
Rabies is one of the deadliest acute infectious diseases for humans, with a mortality rate close to 100% once contracted. In recent years, reported deaths from rabies have remained at the forefront of legally reportable infectious diseases in China. Currently, there are no effective treatments for rabies, thus timely vaccination after exposure is crucial in preventing rabies.
Compared to traditional human rabies vaccines, the mRNA rabies vaccine has the following advantages: higher immunogenicity; requires fewer doses to achieve immunity (two or three doses) compared to traditional vaccines (four or five doses), with a simpler dosing regimen; production does not involve complex cell culture processes, making it easier to produce; fewer impurities from raw materials, making purification easier; higher batch-to-batch consistency in quality; and potentially offering greater safety by reducing the associated risks of injecting inactivated viruses or foreign cells into the body.
According to a research paper published in the "Virology Journal," animal experimental data shows that the Aimei vaccine's mRNA rabies vaccine under research provides immunity against the rabies virus with just two doses, effectively induces antibody production, and stimulates cellular immune responses. The highest level of immune protection is observed when administered to mice with a 14-day interval between doses. Additionally, this vaccine has been verified for both prevention and treatment of rabies virus, as beagle dogs vaccinated with it can generate protective antibody levels and display a 100% survival rate three months after infection.
Aimei Vaccine is the world's second-largest rabies vaccine manufacturer. Its Vero cell freeze-dried human rabies vaccine has maintained a 100% pass rate in the quality review of batch issuance by the China Institute of Food and Drug Control for 15 consecutive years, setting the longest record among all human rabies vaccine suppliers in China, with a cumulative batch issuance exceeding 100 million doses.
In Aimei Vaccine's current R&D pipeline layout, the rabies vaccine has a complete iterative upgrade plan and design. Based on the existing classic product, the Vero cell freeze-dried human rabies vaccine, there will be three iteratively upgraded rabies vaccines rapidly entering R&D, including the serum-free Vero cell rabies vaccine already approved for clinical use, the human diploid cell rabies vaccine, and the mRNA rabies vaccine. The mRNA rabies vaccine is an important upgraded iterative product.
Aimei Vaccine possesses an independent mRNA production and drug delivery technology platform, having applied for multiple invention patents in drug design, production, and formulation delivery. It is also one of the first domestic enterprises to obtain clinical approval for mRNA COVID-19 vaccines.
Rabies is one of the deadliest acute infectious diseases for humans, with a mortality rate close to 100% once contracted. In recent years, reported deaths from rabies have remained at the forefront of legally reportable infectious diseases in China. Currently, there are no effective treatments for rabies, thus timely vaccination after exposure is crucial in preventing rabies.
