Securities code: 688166 Securities abbreviation: Borui Pharmaceutical Announcement No.: 2025-004

Borui Biopharmaceutical (Suzhou) Co., Ltd

Voluntary Disclosure in relation to the approval of the marketing application for the Isaconazole sulfate API

Announcement of the Admission 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" issued by the State Drug Administration.

The relevant information is hereby announced as follows:

First, the basic information of the product

Registration number: Y20230000572

Name of chemical API: isaconazole sulfate

Packing: 0.1kg/bag, 0.2kg/bag, 0.5kg/bag, 1kg/bag, 2kg/bag, 5kg/bag, 10kg/bag, 15kg/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. 10, Tongyuan Road, Taixing Economic Development Zone

2. Other relevant conditions of drugs

Isaconazole sulfate is used to treat the following infections in adults: invasive aspergillosis, invasive mucormycosis.

The corresponding preparations of isaconazole sulfate are mainly isaconazole sulfate for injection, according to statistics, sulfuric acid for injection

The domestic sales of isavuconazole in 2022 will be 20 million yuan, and the domestic sales in 2023 will be 136 million yuan, 2024

The annual domestic sales are 167 million yuan (data from Pharmcube IPM?) database).

3. Impact on the company and related risk warnings

The approval of the marketing application for the chemical API of isaconazole sulfate indicates that the API has met the relevant national technical standards for drug evaluation 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 isaconazole sulfate API on the company's operating results 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

March 18, 2025