The clinical trial of the trivalent influenza vaccine jointly applied for by Kangtai Biological and Bailing Biological has been approved

August 19, 2025  Source: drugdu 161

On August 18th, Kangtai Biological (300601) issued an announcement, stating that the trivalent influenza virus split vaccine (MDCK cells) jointly applied for by it and Lanzhou Bailing Biotechnology Co., Ltd. has been approved by the relevant review for drug registration, allowing clinical trials to be conducted in people aged 3 and above. This clinical trial will include Phase I and Phase III randomized, blinded, positive-controlled studies, mainly evaluating the safety and immunogenicity of the vaccine.

The announcement mentioned that the clinical trial can only be carried out after the three batches of finished products and the various types of the original liquid have been verified as qualified. Meanwhile, the company needs to improve the relevant production processes to ensure that the safety risks of clinical trial samples are controlled within a reasonable range. The announcement also emphasized multiple research areas that need to be focused on during clinical trials, including the selection of virus strains, the optimization of production processes, and the improvement of quality standards, to ensure the effectiveness and safety of the vaccine.

In the first quarter of 2025, Kangtai Biological achieved an income of 645 million yuan and a net profit attributable to the parent company of 22.43 million yuan.

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