-- Announcement on Voluntary Disclosure of Approval for Diphtheria, Tetanus, Pertussis (Acellular, Component) and Haemophilus Type b Conjugate Vaccine, Adsorbed
Securities code: 688276 Securities abbreviation: Baike Biotechnology Announcement number: 2025-037
Changchun Baike Biotechnology Co., Ltd.
Announcement on the Approval of the Approval of the Clinical Trial Application for the Adsorbed Acellular Diphtheria Influenzae Type B Combined Vaccine
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents in accordance with the law.
Important content reminder:
Changchun Baike Biotechnology Co., Ltd. (hereinafter referred to as the "Company") recently received the "Drug Clinical Trial Approval Notice" for the adsorbed acellular Haemophilus influenzae type b combined vaccine issued by the State Food and Drug Administration.
There is a certain degree of uncertainty in the subsequent clinical trials of the adsorbed acellular diphtheria pertussis pertussis and Haemophilus influenzae type b combined vaccine approved for clinical trials this time, and there is also a certain degree of uncertainty in whether the commercial purpose can ultimately be achieved. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
The relevant information is now announced as follows:
1. Main information of the "Drug Clinical Trial Approval Notice"
Acceptance number: CXSL2500582
Notice number: 2025LP02637
Drug name: Adsorbed acellular diphtheria and Haemophilus influenzae type b combined vaccine
Conclusion: It is recommended to approve clinical trials for the prevention of pertussis, diphtheria, tetanus and invasive infections caused by Haemophilus influenzae type b (including meningitis, pneumonia, sepsis, cellulitis, arthritis, epiglottitis, etc.).
Approval date: October 9, 2025
2. Introduction to adsorbed acellular diphtheria pertussis pertussis and Haemophilus influenzae type b combined vaccine
The combined vaccine has the advantage of "one dose for multiple protections", which can reduce the number of vaccinations, reduce vaccination costs, and increase vaccination coverage. Because it conforms to public health needs and the development trend of immunization, it is becoming an important direction for domestic vaccine development.
The company's clinically approved adsorbed acellular diphtheria-pertussis-pertussis-Hib combination vaccine (hereinafter referred to as "DPT-Hib combination vaccine") is a vaccine that can simultaneously prevent pertussis, diphtheria, tetanus and Haemophilus influenzae type b. The vaccination targets infants and young children aged 2 months and above. After vaccination, it can stimulate the body's immune response and be used to prevent invasive infections caused by whooping cough, diphtheria, tetanus and Haemophilus influenzae type b.
The company's adsorbed acellular DPT (three-component) combination vaccine (hereinafter referred to as "DPT vaccine (three-component)") and freeze-dried Haemophilus influenzae type b conjugate vaccine (hereinafter referred to as "Hib vaccine") are the foundation and core of the DPT-Hib combination vaccine. Among them:
① DPT vaccine (three components) targets the national strategic needs and breaks the traditional co-purification process. It has the characteristics of clear antigen components, high purity and good inter-batch consistency. At present, the domestic DPT vaccine used in our country still uses a co-purified process, while developed countries have replaced the co-purified DPT vaccine with a component DPT vaccine. After checking the website of the State Food and Drug Administration, no domestic manufacturer’s adsorbed acellular diphtheria-tetanus pertussis (component) combination vaccine product has been approved for marketing. Currently, this product is undergoing Phase III clinical trials.
②Hib vaccine uses a phenol-free polysaccharide purification process to prepare high-purity Hib polysaccharide, and uses a polysaccharide degradation process to make the molecular weight of the prepared polysaccharide derivatives more uniform, which is beneficial to ensuring batch-to-batch consistency and immunogenicity of product quality. Currently, the clinical trial application for this product has been approved. For details, please refer to the "Announcement of Changchun Baike Biotechnology Co., Ltd. on the Approval of Voluntary Disclosure of the Clinical Trial Application for Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine" disclosed by the company on the Shanghai Stock Exchange website (www.sse.com.cn) on December 26, 2024 (Announcement Number: 2024-050).
The Hib vaccine in the company's DPT-Hib combination vaccine approved this time is a freeze-dried dosage form, which is used in combination with the liquid DPT vaccine (three components). Compared with using DPT vaccine and Hib vaccine separately, the number of injections is reduced, thereby improving the compliance of infants and young children with vaccination.
3. Impact on the company
If the approved DPT-Hib combined vaccine successfully completes clinical trials and is approved for marketing, it will further improve the company's combined vaccine research and development pipeline, help the company optimize its product structure and comprehensive development of its main business, provide the public with higher-quality vaccination options, and help the company's combined vaccine achieve new breakthroughs and create new growth points for the company's performance.
4. Risk warning
There is a certain degree of uncertainty in the subsequent clinical trials of the company's DPT-Hib combination vaccine, and there is also a certain degree of uncertainty in whether it can ultimately achieve its commercial goals.
The company will actively promote the above-mentioned research and development projects in accordance with relevant national regulations and perform its information disclosure obligations on the subsequent progress of the projects in a timely manner.
The acquisition of the "Drug Clinical Trial Approval Notice" for the DPT-Hib combined vaccine will not have a significant impact on the company's recent performance. Investors are advised to make prudent decisions and pay attention to guarding against investment risks.
Announcement is hereby made.
Changchun Baike Biotechnology Co., Ltd. Board of Directors
October 10, 2025