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Securities code: 688276 Securities abbreviation: Baike Biotech Announcement Number: 2024-049

Changchun Baike Biotechnology Co., Ltd. on the voluntary disclosure of herpes simplex virus type II mRNA vaccine

Announcement of approval of the clinical trial application

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

Important Content Notes:

1. Changchun Baike Biotechnology Co., Ltd. (hereinafter referred to as "the company") recently received the "Drug Clinical Trial Approval Notice" issued by the State Drug Administration.

2. There is some uncertainty in the follow-up clinical trial of the herpes simplex virus mRNA vaccine type II, and there is also some uncertainty about whether the commercial purpose can be finally achieved. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

The relevant situation is hereby announced as follows:

1. The main information of the "Notice of Approval of Drug Clinical Trial".

Acceptance number: CXSL2400665

Notice No.: 2024LP02949

Drug name: LVRNA101

Conclusions: It was agreed to conduct a clinical trial for the prevention of genital herpes caused by herpes simplex virus type II infection.

Approval date: December 19, 2024

The LVRNA101 approved by the company this time is the herpes simplex virus mRNA vaccine type II (i.e., the "HSV-2 vaccine").

2. Introduction to herpes simplex virus mRNA vaccine type II

Genital herpes caused by herpes simplex virus type II infection is an infectious disease with sex as the main mode of transmission, which is susceptible to infection, recurrent and has no effective cure, and has become a serious public health problem. In order to prevent the occurrence of genital herpes, a number of biopharmaceutical companies have been committed to the research and development of herpes simplex virus vaccines.

The herpes simplex virus vaccine type II approved for clinical trial by the company is jointly declared with Zhuhai Livanda Biotechnology Co., Ltd. (the company is the approval holder), which is a multi-component vaccine, which can induce humoral immune response and cellular immune response at the same time, and further enhance the cellular immune response by using mRNA technology route, which improves the possibility of successful vaccine development compared with the traditional technical route.

Up to now, no related vaccine products have been successfully developed and marketed in the world. If the company's herpes simplex virus type II mRNA vaccine can be successfully developed, it will further enrich the company's product pipeline and better meet the market demand.

3. Impact on the company

If the vaccine variety successfully completes clinical trials and is approved for marketing, it will help the company optimize its product structure, industrial layout and overall development of its main business, and enhance the company's long-term profitability.

4. Risk Warning

1. There is a certain degree of uncertainty in the follow-up clinical trial of the company's type II herpes simplex virus mRNA vaccine, and there is also a certain uncertainty about whether the commercial purpose can be finally achieved.

2. The company will actively promote the above-mentioned R&D projects in accordance with relevant national regulations, and fulfill the obligation of information disclosure for the follow-up progress of the project in a timely manner.

3. The "Notice of Approval of Drug Clinical Trials" for the type II herpes simplex virus mRNA vaccine will not have a significant impact on the company's recent performance.

The announcement is hereby made.

Board of Directors of Changchun Baike Biotechnology Co., Ltd

December 21, 2024