Chongqing Zhifei Biological Products Co.Ltd(300122) lyophilized recombinant tuberculosis vaccine entered phase IIa clinical trial

Chongqing Zhifei Biological Products Co.Ltd(300122) announced on February 11 that recently, it was learned from Anhui zhifeilong Kema biopharmaceutical Co., Ltd., a wholly-owned subsidiary, that the “freeze-dried recombinant tuberculosis vaccine (AEC / bc02)” developed by it has completed phase I clinical research, and the results preliminarily show that the vaccine has good safety and tolerance. At present, the preparation for phase IIa clinical trial of the product has been completed, the subject screening has been started, and the phase IIa clinical trial has been officially launched in Hengdong County, Hengyang City, Hunan Province.

Data show that tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis infection. According to the WHO (WHO) assessment, about 1 billion 700 million of tuberculosis latent infection population, accounting for 1/4 of the total population, screening and prevention of tuberculosis latent infection population is the most important part of World Health Organization’s end TB strategy. In 2015, WHO proposed the strategy of “terminating TB”, whose goal is to reduce the incidence rate of tuberculosis to less than 10/10 million by 2035. For the first time, it is proposed that LTBI detection and preventive intervention should be carried out in high-risk groups to reduce TB incidence. It is also pointed out that if the problem of latent infection of tuberculosis is not resolved, the goal of terminating tuberculosis can not be achieved.

According to Chongqing Zhifei Biological Products Co.Ltd(300122) , the freeze-dried recombinant tuberculosis vaccine (AEC/BC02) is intended to be used for the prevention of tuberculosis in people over 18 years of age and the latent infection of Mycobacterium tuberculosis, which belongs to 1 categories of biological products for prevention. Up to now, after inquiring the website of the State Food and drug administration, there is no similar vaccine on the market outside China.

The company said that if the research and development of the project goes smoothly, it will form a synergistic effect with the company’s tuberculosis matrix products (Mycobacterium vaccae for injection (micro card), etc.) to provide people with more diversified immune options.

According to the latest performance express, the operating revenue of Chongqing Zhifei Biological Products Co.Ltd(300122) in 2021 was 30.637 billion yuan, a year-on-year increase of 101.68%; The operating profit was 11.986 billion yuan, a year-on-year increase of 207.73%; The net profit attributable to the parent company was 10.197 billion yuan, an increase of 208.88%, and the earnings per share was 6.3731 yuan. (Wang Yi)

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