Zhifei Biotechnology: Announcement on the acceptance of clinical trial application for freeze-dried chickenpox inactivated vaccine
Securities code: 300122 Securities abbreviation: Zhifei Biotechnology Announcement number: 2025-68
Chongqing Zhifei Biological Products Co., Ltd.
Announcement on the acceptance of clinical trial application for freeze-dried chickenpox inactivated vaccine
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and that there are no false records, misleading statements or major omissions.
Chongqing Zhifei Biological Products Co., Ltd. (hereinafter referred to as the "Company") recently learned that the freeze-dried varicella inactivated vaccine developed by its wholly-owned subsidiary Anhui Zhifei Longkoma Biopharmaceutical Co., Ltd. (hereinafter referred to as "Zhifei Longkoma") has received a drug clinical trial application acceptance notice from the National Medical Products Administration (acceptance number: CXSL2500962). If no negative or questioning opinions are received from the Center for Drug Evaluation within 60 days from the date of acceptance, Zhifeilongkoma can conduct clinical trials in accordance with the submitted plan.
1. Introduction to R&D projects
Chickenpox is a febrile and rash disease caused by varicella-zoster virus (VZV). After initial infection with varicella-zoster virus (usually in childhood), it manifests as chickenpox and is latent in the ganglia; when immunity is low, the latent virus can be reactivated (usually in adulthood or old age), manifesting as herpes zoster. Typical symptoms of chickenpox include prodromal symptoms such as fever, headache, and general malaise, followed by a centripetally distributed rash. The rash evolves from red maculopapular rash → small oval drop-shaped blisters → scabs, often accompanied by severe itching. Severe chickenpox is more common in people with low immune function, such as infants, pregnant women, and HIV-infected people, and may cause serious complications such as hemorrhagic rash, pneumonia, and encephalitis. Chickenpox is known as "meet-to-face spread" and is highly contagious. Droplet transmission is one of the most important ways of spreading the varicella-zoster virus. In addition, the virus can also be spread through direct contact. All people who have not been vaccinated against chickenpox or have not had chickenpox may develop the disease after infection. Vaccination with chickenpox vaccine is the most effective way to prevent chickenpox. The freeze-dried inactivated varicella vaccine developed by Zhifeilong Kema is used to prevent diseases caused by varicella-zoster virus infection.
2. The significance of being accepted
The freeze-dried chickenpox inactivated vaccine developed by Zhifeilong Kema adopts an innovative inactivation technology route, and the cell lines and virus strains used for production are independently developed by the company. This product has significant safety advantages and is suitable for the prevention of chickenpox in people aged 12 months and above. It can provide more safe options for normal healthy people and people with immune deficiencies or contraindications to vaccinate against chickenpox.
As of the date of this announcement, after checking the official website of the State Food and Drug Administration, there are 8 live attenuated varicella vaccines approved for marketing in China, and no inactivated varicella vaccine has been officially approved for marketing. The market prospects are broad.
The company's clinical trial application for freeze-dried chickenpox inactivated vaccine was accepted, which is the result of the company's focus on innovative technologies and strengthening core research. If this project progresses smoothly, it will further enrich the company's upgraded vaccine varieties, improve the company's product layout, and strengthen the company's market position.
3. Risk warning
Drug research and development is a very complex and rigorous scientific activity with the characteristics of large investment, long cycle and high risk. Product research and development and administrative approval mainly include the following stages: preclinical research; application for clinical trial; conduct clinical trial; application for production license number; and marketing.
The acceptance of the company's freeze-dried chickenpox inactivated vaccine clinical trial application will not have a significant impact on the company's recent performance. If future product development goes smoothly, it will enrich the company's product structure and enhance the company's profitability and core competitiveness.
There are uncertainties in the progress, results and product launch of the subsequent clinical trials of this project. The company will fulfill its information disclosure obligations in a timely manner based on the progress of research and development.
Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
Announcement hereby
Board of Directors of Chongqing Zhifei Biological Products Co., Ltd.
November 12, 2025