NEWS
APPLICATION FOR CLINICAL TRIAL OF THE ITERATIVE-PROCESS HIGHLY-EFFECTIVE HUMAN DIPLOID RABIES VACCINE
The application for clinical trial of the iterative-process highly-effective human diploid rabies vaccine developed by the Group has been submitted to the Center for Drug Evaluation (CDE) of National Medical Products Administration of China recently.
Rabies is the most deadly disease in the world, with a fatality rate of nearly 100%. Currently, there is a lack of effective treatment for rabies in clinical practice, therefore, post-exposure prevention is crucial, and the main preventive measure is vaccination against human rabies. There are two kinds of rabies vaccines, namely the serum-containing rabies vaccine and the serum-free rabies vaccine. However, no serum-free rabies vaccine has been registered or marketed yet. The mainstream Vero cell rabies vaccine and human diploid rabies vaccine currently available in the market are serum-containing rabies vaccines.
Compared with the traditional Vero cell rabies vaccines, human diploid rabies vaccine uses human diploid cells instead of Vero cells, which are homologous to humans and have a natural safety advantage. The human diploid rabies vaccine currently available in the market is 3 to 5 times more expensive than the Vero cell rabies vaccine, with higher product added value.
Compared with the traditional human diploid rabies vaccines of the first generation, the iterative-process highly-effective human diploid rabies vaccine developed by the Group has taken the lead in breaking through the technical bottlenecks of low virus titer and low yield in the traditional process. It has been optimized and innovated in the purification process with the product quality and safety significantly improved.
Compared with the number of traditional rabies vaccinations, this product developed by the Group can be vaccinated with either “five-needle approach”, “simple four-needle approach” or “2-1-1 four-needle approach”, which is more flexible and convenient.
The Group has completed the construction of an iterative-process high-efficiency human diploid rabies vaccine workshop that meets international standards, and has completed the production of commercial-scale Phase III clinical trial samples, which is capable of producing this product in large scale.
As the world’s second largest supplier of rabies vaccines, the Group is committed to leading the in-depth technology iteration and upgrading of rabies vaccines globally and providing the market with a series of rabies vaccine products with better quality and higher safety, thereby promoting the sustainable development of the Company.
Rabies is the most deadly disease in the world, with a fatality rate of nearly 100%. Currently, there is a lack of effective treatment for rabies in clinical practice, therefore, post-exposure prevention is crucial, and the main preventive measure is vaccination against human rabies. There are two kinds of rabies vaccines, namely the serum-containing rabies vaccine and the serum-free rabies vaccine. However, no serum-free rabies vaccine has been registered or marketed yet. The mainstream Vero cell rabies vaccine and human diploid rabies vaccine currently available in the market are serum-containing rabies vaccines.
Compared with the traditional Vero cell rabies vaccines, human diploid rabies vaccine uses human diploid cells instead of Vero cells, which are homologous to humans and have a natural safety advantage. The human diploid rabies vaccine currently available in the market is 3 to 5 times more expensive than the Vero cell rabies vaccine, with higher product added value.
Compared with the traditional human diploid rabies vaccines of the first generation, the iterative-process highly-effective human diploid rabies vaccine developed by the Group has taken the lead in breaking through the technical bottlenecks of low virus titer and low yield in the traditional process. It has been optimized and innovated in the purification process with the product quality and safety significantly improved.
Compared with the number of traditional rabies vaccinations, this product developed by the Group can be vaccinated with either “five-needle approach”, “simple four-needle approach” or “2-1-1 four-needle approach”, which is more flexible and convenient.
The Group has completed the construction of an iterative-process high-efficiency human diploid rabies vaccine workshop that meets international standards, and has completed the production of commercial-scale Phase III clinical trial samples, which is capable of producing this product in large scale.
As the world’s second largest supplier of rabies vaccines, the Group is committed to leading the in-depth technology iteration and upgrading of rabies vaccines globally and providing the market with a series of rabies vaccine products with better quality and higher safety, thereby promoting the sustainable development of the Company.
