The board of directors and all directors of our company guarantee that there are no false records, misleading statements or significant omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content. Recently, Tianjin Hengrui Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received approval from the National Medical Products Administration (hereinafter referred to as the "NMPA") to issue a "Drug Clinical Trial Approval Notice" for fluoride [18F] metoprolol injection, and will conduct clinical trials in the near future.

Basic information of drugs
Drug Name: Fluorine [18F] Metoprolol Injection Form: Injection Application Matters: Clinical Trial Acceptance Number: CYHL2400142 Approval Conclusion: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after examination, the Fluorine [18F] Metoprolol Injection accepted on July 9, 2024 meets the relevant requirements for drug registration and is approved for clinical trial of "Positron Emission Tomography (PET) imaging for evaluating the density of neuroinflammation plaques formed by β - amyloid protein aggregation in adult patients with cognitive impairment caused by Alzheimer's disease (AD) or other reasons".

Other aspects of medication
Fluorine [18F] metoprolol injection is a radioactive diagnostic agent used for brain positron emission tomography imaging to evaluate the density of neuroinflammatory plaques formed by β - amyloid protein aggregation in adult patients with cognitive impairment caused by Alzheimer's disease or other reasons using PET imaging. The original drug [18F] Flutemetamol Injection was approved for market in the United States in October 2013 under the trade name Vizamyl. The product has not yet been registered or declared in China, and no relevant sales data has been found. As of now, a total of approximately 22.88 million yuan has been invested in research and development for projects related to fluoride [18F] metoprolol injection.

Risk statement
According to the relevant laws and regulations on drug registration in China, after obtaining the drug clinical trial approval notice, the drug still needs to undergo clinical trials and be reviewed and approved by the National Medical Products Administration before it can be produced and marketed. The process of drug development, clinical trial approval, and production is long and involves multiple stages. Drug development and market launch are easily affected by uncertain factors. Investors are advised to make cautious decisions and take precautions against investment risks. The company will actively promote the above-mentioned research and development projects in accordance with relevant national regulations, and fulfill its obligation to disclose information on the subsequent progress of the projects in a timely manner. This is to announce.

Source: https://pharm.jgvogel.cn/c1448907.shtml