Securities code: 688166 Securities abbreviation: Borui Pharmaceutical Announcement No.: 2024-087

Borui Biopharma (Suzhou) Co., Ltd. voluntary disclosure

Announcement on the approval of fondaparinux and heparinux injection by the US FDA

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 Biopharma (Suzhou) Co., Ltd. (hereinafter referred to as the "Company") received a notice from the U.S. Food and Drug Administration (hereinafter referred to as the "FDA") that the abbreviated new drug application (ANDA, i.e., the U.S. generic drug application) submitted to the FDA for the company's application to the FDA has been officially approved.

The relevant information is hereby announced as follows:

1. Basic information of drugs

Drug Name: Fondaparinux Decanosodium Injection

Dosage form: injection

Specification: 2.5mg/0.5ml

Holder: Borui Biopharmaceutical (Suzhou) Co., Ltd

ANDA NO.: 218312

2. Other relevant information of the drug

Fondaparinux is a fully synthetic anticoagulant drug, which is suitable for patients undergoing major orthopedic surgery of the lower limbs, such as hip fracture, major knee surgery or hip arthroplasty, to prevent venous thromboembolic events.

For the treatment of patients with unstable angina pectoris or non-ST-elevation myocardial infarction (UA/NSTEMI) for whom urgent (<120 minutes) invasive therapy (PCI) is not indicated.

For the treatment of patients with ST-elevation myocardial infarction who are on thrombolysis or who are not initially treated with other forms of reperfusion therapy.

Fondaparinux Chlorinate Injection was approved by the US FDA in December 2001. According to statistics, fondaliver

The global sales of decanosodium injection from July 2023 to June 2024 were $152 million, of which sales were made in the United States

$27 million (data from the Cortellis database).

3. Impact on the company and related risk warnings

The approval of the company's fondaparinux sodium injection ANDA means that the preparation product meets the quality requirements of the United States Pharmacopeia, and indicates that the preparation product can be sold in the U.S. market.

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. International drug sales are susceptible to policy changes, changes in overseas market environment, exchange rate fluctuations and other factors, and there is still uncertainty about the impact of the approval of fondaparinux and dec sodium injection ANDA on the company's operating results. Investors are advised to make prudent decisions and pay attention to investment risks.

The announcement is hereby made.

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

December 24, 2024