Core Viewpoint - The company Zhonghui Biotech-B (02627) has initiated Phase III clinical trials for its lyophilized rabies vaccine (human diploid cells) aimed at three immunization regimens, marking a significant step in its vaccine development process [1] Group 1: Clinical Trial Progress - The company received approval from the National Medical Products Administration of the People's Republic of China for new drug clinical trials for the Essen (five-dose) regimen in November 2022 [1] - In April 2023, the company obtained approval for supplementary clinical trial applications for the Zagreb (four-dose) and simplified four-dose regimens [1] - The company completed Phase I clinical trials for the rabies vaccine in October 2024 [1] Group 2: Vaccine Characteristics - Rabies is a severe viral disease caused by the rabies virus, leading to serious symptoms such as confusion and progressive paralysis, which are almost always fatal once symptoms appear [1] - Immediate vaccination after exposure to the virus can prevent rabies [1] - The rabies vaccine developed using human diploid cells is recognized as the "gold standard" rabies vaccine by the World Health Organization, demonstrating strong safety profiles [1] - The rabies vaccine has shown good safety characteristics in the completed Phase I clinical trials [1]

Group 1 - Zhonghui Biotech (02627) has successfully held the launch meeting for the Phase III clinical trial of its lyophilized human rabies vaccine (human diploid cells) in Hubei, marking a significant step towards successful commercialization of this core product [1] - Rabies is a zoonotic disease caused by the rabies virus (RABV), with a widespread geographical distribution affecting over 150 countries and regions, posing a severe threat to human life due to nearly 100% mortality once symptoms appear [1] - The onset of rabies symptoms is related to the speed at which the virus moves to the central nervous system, typically occurring 20 to 60 days post-infection, leading to acute encephalomyelitis and subsequent respiratory and circulatory failure [1] Group 2 - Currently, there is no effective treatment for rabies, making prevention crucial, with vaccination being the most effective control measure [2] - Human diploid cell rabies vaccine (HDCV) has a history of over 40 years of use in Europe and North America, with its safety and efficacy well-validated, recognized internationally as the "gold standard" for rabies vaccines [2] - The lyophilized human rabies vaccine (human diploid cells) has completed Phase I clinical trials, showing good safety profiles for both the Essen and Zagreb vaccination protocols in individuals aged 10 to 60 [2]

Group 1 - Zhonghui Biotech (02627) has successfully held the launch meeting for the Phase III clinical trial of its lyophilized human rabies vaccine (human diploid cells) in Hubei, marking a significant step towards successful commercialization of this core product [1] - Rabies is a highly infectious disease caused by the rabies virus (RABV), with a global presence in over 150 countries and regions, posing a severe threat to human life due to nearly 100% mortality once symptoms appear [2] - The human diploid cell rabies vaccine (HDCV) has a history of over 40 years of application in Europe and North America, with its safety and efficacy well-validated, recognized internationally as the "gold standard" for rabies vaccines [2]