NEWS
SUBMISSION OF THE PRE-APPLICATION FOR MARKETING REGISTRATION OF THE ITERATIVE SERUM-FREE RABIES VACCINE
The pre-application for marketing registration of the iterative serum-free rabies vaccine independently developed by the Group has been submitted to the National Medical Products Administration recently.
According to the results of the Phase III clinical trials that has completed unblinding, the Group’s iterative serum-free rabies vaccine has good safety, immunogenicity and immune persistence and has met the pre-defined clinical objectives.
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.
Completely unlike the traditional Vero cell rabies vaccine and human diploid rabies vaccine, the iterative serum-free rabies vaccine developed by the Group is an iterative upgraded product. Animal serum residues in vaccine products are one of the important factors leading to adverse reactions such as allergies in vaccinated populations, and the iterative serum-free rabies vaccine developed by the Group does not contain animal serum, which significantly improves safety and reduces the probability of adverse reactions. To date, there is no serumfree rabies vaccine that has been approved for launch in the global market, and this product is expected to be the first one on the market.
The Group has completed the construction of an iterative serum-free rabies vaccine workshop that meets international standards, as well as the commercial-scale validation production, and is now 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.
According to the results of the Phase III clinical trials that has completed unblinding, the Group’s iterative serum-free rabies vaccine has good safety, immunogenicity and immune persistence and has met the pre-defined clinical objectives.
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.
Completely unlike the traditional Vero cell rabies vaccine and human diploid rabies vaccine, the iterative serum-free rabies vaccine developed by the Group is an iterative upgraded product. Animal serum residues in vaccine products are one of the important factors leading to adverse reactions such as allergies in vaccinated populations, and the iterative serum-free rabies vaccine developed by the Group does not contain animal serum, which significantly improves safety and reduces the probability of adverse reactions. To date, there is no serumfree rabies vaccine that has been approved for launch in the global market, and this product is expected to be the first one on the market.
The Group has completed the construction of an iterative serum-free rabies vaccine workshop that meets international standards, as well as the commercial-scale validation production, and is now 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.
