Zhifei Biotech announced on the evening of April 1 that the trivalent influenza virus split vaccine (ZFA02 adjuvant) (referred to as "adjuvanted trivalent influenza vaccine") developed by its wholly-owned subsidiary Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. has recently obtained the National Drug Administration's drug clinical trial approval notice (notice number: 2025LP00953), agreeing to conduct clinical trials to prevent influenza caused by vaccine-related influenza viruses. The company stated that it will carry out relevant clinical trials as soon as possible according to the requirements of the clinical trial approval.

It is understood that influenza is an acute respiratory infectious disease caused by influenza virus that can cause large-scale epidemics. It is highly contagious and can cause complications such as pneumonia, bronchitis, and myocarditis. It can also aggravate the basic diseases of high-risk groups such as the elderly and the weak. Vaccination against influenza is the most economical and effective measure to prevent influenza diseases and influenza outbreaks.

The trivalent influenza vaccine with adjuvant approved for this clinical trial application contains the company's independently developed ZFA02 adjuvant, which can stimulate the body to produce humoral and cellular immune responses against influenza virus antigen hemagglutinin (HA) after vaccination, and is used to prevent influenza caused by vaccine-related influenza viruses.

So far, after checking the website of the National Medical Products Administration, no adjuvant influenza vaccine has been officially approved for marketing in China. Seqirus' adjuvant influenza vaccine has been approved for marketing overseas.

Zhifei Bio said that the company's trivalent influenza vaccine with adjuvant clinical trial application was approved, which is the application of the company's new adjuvant technology platform and the result of the company's focus on innovative technology and strengthening core research. If the project progresses smoothly, it will further enrich the company's virus vaccine varieties, and form a synergistic effect with the company's approved quadrivalent influenza virus split vaccine, the trivalent influenza virus split vaccine in the application stage, the quadrivalent influenza virus split vaccine (children's type), and the quadrivalent influenza virus split vaccine (ZFA02 adjuvant) approved for clinical trials, improve the company's product layout, and enhance the company's market competitiveness.

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