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]
中慧生物-B：冻干人用狂犬病疫苗(人二倍体细胞)的III期临床试验启动