Securities code: 688166 Securities abbreviation: Borui Pharmaceutical Announcement No.: 2025-002

Borui Biopharmaceutical (Suzhou) Co., Ltd

Voluntary Disclosure on Dopamine Hydrochloride API Approved for Marketing Application

Announcement of the Notice

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.

Recently, Borui Pharmaceutical (Suzhou) Co., Ltd., a wholly-owned subsidiary of Borui Biopharmaceutical (Suzhou) Co., Ltd. (hereinafter referred to as the "Company"), received the "Notice of Approval of Marketing Application for Chemical APIs" for "Dopamine Hydrochloride" issued by the State Drug Administration.

The relevant information is hereby announced as follows:

First, the basic information of the product

Registration number: Y20230000687

Chemical API name: dopamine hydrochloride

Packing: 0.5kg/bag, 1kg/bag, 2kg/bag, 3kg/bag

Application matters: Application for the listing of domestically produced chemical APIs

Approval conclusion: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after review, this product meets the relevant requirements of drug registration and is approved for registration.

Manufacturer: Borui Pharmaceutical (Suzhou) Co., Ltd

Production address: No. 22, Binjiang South Road, Taixing Economic Development Zone

2. Other relevant conditions of drugs

Dopamine hydrochloride is suitable for shock syndrome caused by myocardial infarction, trauma, endotoxin sepsis, cardiac surgery, renal failure, congestive heart failure, etc.; Shock that cannot be corrected after volume replacement, especially shock with oliguria and normal or low peripheral vascular resistance. Because this product can increase cardiac output, it is also used in foreign countries

Cardiac insufficiency that does not respond to yellow and diuretics.

The corresponding preparation of dopamine hydrochloride is mainly dopamine hydrochloride injection, according to statistics, dopamine hydrochloride injection

The company's domestic sales will be 352 million yuan in 2022 and 352 million yuan in 2023 and before 2024

Domestic sales in the third quarter were 209 million yuan (data from PharmcubeIPM database).

3. Impact on the company and related risk warnings

The dopamine hydrochloride API obtained the "Notice of Approval of Marketing Application for Chemical API", indicating that the API has met the relevant national drug evaluation technical standards and has been approved for use in domestic preparations, which will enrich the company's API product pipeline and help the company expand the sales of this variety.

The company attaches great importance to drug research and development, and strictly controls the quality and safety of drug research and development, manufacturing and sales. Due to uncertain factors such as industry policies and market environment, there is still uncertainty about the impact of dopamine hydrochloride API on the company's operating performance through the approval of the marketing application. Investors are advised to make prudent decisions and pay attention to preventing investment risks.

The announcement is hereby made.

Board of Directors of Borui Biopharmaceutical (Suzhou) Co., Ltd

January 7, 2025