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On November 12, Wantai Biotech issued an announcement.
Recently, the nasal spray influenza virus carrier new crown pneumonia vaccine ("nasal spray new crown vaccine") developed by it in cooperation with Xiamen University and the University of Hong Kong has won Phase III issued by the South African Drug Administration.
The clinical trial approval document approved an international multi-center, randomized, double-blind, placebo-controlled phase III clinical trial of the protective efficacy and safety of the nasal spray neocorona vaccine in adult subjects 18 years of age and older
.
The nasal spray new crown vaccine is a double attenuated common seasonal influenza virus (CA4-DelNS1) vector inserted into the RBD gene sequence of the new coronavirus protective antigen.
Prevention of new coronary pneumonia
.
The vaccine is one of China's five new crown vaccine research and development technical routes deployed by the country, and is developed by the company in cooperation with the University of Hong Kong and Xiamen University
The nasal spray new crown vaccine received the clinical trial approval issued by the National Medical Products Administration on August 27, 2020.
Phase I, Phase II, and expansion clinical trials have been carried out in China.
The phase I clinical trial has completed all planned visits.
Phase I Interim analysis has been completed for both Phase II and Phase II, and the research results show that the vaccine has good safety and immunogenicity
.
Preliminary test data showed that the immune response triggered by the vaccine after nasal spray inoculation was well tolerated to both the prototype and mutant strains of the new coronavirus
In order to accelerate the clinical phase III trial of the nasal spray new crown vaccine, Wantai Biosciences plans to conduct clinical trials in 11 countries including South Africa, Indonesia, and the Philippines.
As of the date of this announcement, Wantai Bio has invested approximately 201 million yuan (unaudited) in research and development costs for the nasal spray new crown vaccine