-- Announcement on Voluntary Disclosure of Obtaining Notice of Approval for Clinical Trials of BGM0504 Tablets

Securities code: 688166 Securities abbreviation: Borui Pharmaceutical Announcement number: 2025-064 Borui Biopharmaceutical (Suzhou) Co., Ltd. voluntarily disclosed the announcement on the approval notice for BGM0504 tablets for drug clinical trials

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:

 Borui Pharmaceutical (Suzhou) Co., Ltd. (hereinafter referred to as "Bori Pharmaceuticals"), a wholly-owned subsidiary of Borui Biopharmaceutical (Suzhou) Co., Ltd. (hereinafter referred to as the "Company"), recently received the "Drug Clinical Trial Approval Notice" issued by the State Food and Drug Administration (hereinafter referred to as the "State Food and Drug Administration"), agreeing to carry out clinical trials of Borui Pharmaceutical's BGM0504 tablets in adult overweight/obese patients.

 Relevant risk warnings:

1. According to the requirements of laws and regulations related to national drug registration, after a drug obtains the "Drug Clinical Trial Approval Notice", it still needs to conduct a series of clinical trials and obtain approval from the State Food and Drug Administration before it can be produced. This will not have a major impact on the company's business in the short term.

2. Drugs have a long R&D cycle, many approval processes, and large R&D investment. Each link is affected by multi-dimensional factors and there are many unpredictable factors. Investors are advised to make prudent decisions and pay attention to preventing investment risks. The company will actively promote the above-mentioned research and development projects and fulfill its information disclosure obligations on subsequent progress in a timely manner in accordance with relevant laws and regulations.

1. Basic information on drugs

Drug name BGM0504 tablets

Dosage form tablet

Specifications 10mg 20mg 40mg

Application Matters Clinical Trial Application

Applicant Borui Pharmaceutical (Suzhou) Co., Ltd.

Acceptance number CXHL2500680 CXHL2500679 CXHL2500681

In accordance with the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, the clinical trial application for BGM0504 tablets accepted on July 10, 2025 meets the requirements for drug registration.

Relevant requirements, agree to conduct clinical trials of this product in adult overweight/obese patients.

2. Drug-related situations

BGM0504 is a dual agonist of GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors independently developed by the company. It can activate the downstream pathways of GIP and GLP-1, produce biological effects such as blood sugar control, weight loss and treatment of non-alcoholic steatohepatitis (NASH), showing the potential to treat a variety of metabolic diseases.

BGM0504 injection is currently in Phase III clinical trials in China for the two indications of type 2 diabetes and weight loss. BGM0504 tablets are the oral dosage form of BGM0504. As of the date of this announcement, no similar target oral dosage form has been approved for marketing in the world.

3. Risk warning

1. According to the requirements of laws and regulations related to national drug registration, after a drug obtains the "Drug Clinical Trial Approval Notice", it still needs to conduct a series of clinical trials and obtain approval from the State Food and Drug Administration before it can be produced. This will not have a major impact on the company's business in the short term.

2. Drugs have a long R&D cycle, many approval processes, and large R&D investment. Each link is affected by multi-dimensional factors and there are many unpredictable factors. Investors are advised to make prudent decisions and pay attention to preventing investment risks. The company will actively promote the above-mentioned research and development projects and fulfill its information disclosure obligations on subsequent progress in a timely manner in accordance with relevant laws and regulations.

Announcement is hereby made.

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

September 16, 2025