-- Announcement on Obtaining Drug Registration Certificate for Amlodipine Besilate and Benazepril Hydrochloride Capsules
Securities code: 601089 Securities abbreviation: Fuyuan Pharmaceutical Announcement number: Lin 2025-062
Beijing Fuyuan Pharmaceutical Co., Ltd.
Announcement on Amlodipine Benazepril Capsules Obtaining Drug Registration Certificate
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.
Recently, Beijing Fuyuan Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received the amlodipine benazepril capsules (specifications: each capsule contains 5 mg of amlodipine besylate (calculated as C₂₀H₂₅ClN₂O₅) and benazepril hydrochloride) issued by the State Food and Drug Administration (hereinafter referred to as the "State Food and Drug Administration") 10mg) (hereinafter referred to as "the drug") "Drug Registration Certificate" (Certificate Number: 2025S02582), approving the production of the drug. The relevant information is now announced as follows:
1. Main contents of drug registration certificate
Generic name of the drug: Amlodipine Benazepril Capsules
Drug name English name/Latin name: Amlodipine Besilate and
Benazepril Hydrochloride Capsules
Dosage form capsule
Registration classification: Chemicals Class 3
Each tablet contains amlodipine besylate 5mg (according to C₂₀H₂₅ClN₂O₅ specification
(calculated) with benazepril hydrochloride 10mg
Drug approval number: National Drug Approval Number H20255200
Drug registration standard number YBH19592025
Prescription/Over-the-Counter Drugs Prescription Drugs
Application Matters Drug Registration (Domestic Production)
According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration.
Approve registration and issue drug registration certificate. Quality standards, review and approval conclusions
The instructions, labels and production processes are as attached. Drug manufacturing enterprises must comply with the requirements of drug production quality management regulations
Production and sales.
Marketing authorization holder Beijing Fuyuan Pharmaceutical Co., Ltd.
Manufacturer: Beijing Fuyuan Pharmaceutical Co., Ltd.
2. Drug related information
Amlodipine Benazepril Capsules were developed by Novartis and were first approved for marketing in the United States in March 1995. The original manufacturer's Amlodipine Benazepril Capsules have not yet been launched in China. This product is used to treat high blood pressure, but not for the initial treatment of high blood pressure. This product is suitable for patients whose blood pressure cannot be satisfactorily controlled by taking amlodipine or benazepril alone; or as an alternative treatment for patients who take amlodipine tablets and benazepril tablets at the same time.
The company received an application acceptance notice on March 21, 2024, and recently received approval from the State Food and Drug Administration. According to relevant national policies and regulations, obtaining the "Drug Registration Certificate" this time is deemed to have passed the consistency evaluation.
As of the date of this announcement, the company's cumulative R&D investment in this drug is RMB 8.1616 million (unaudited).
3. Market status of similar drugs
According to data from Minai.com, the sales of amlodipine and benazepril oral extended-release dosage forms in China's three major terminals and six major markets in 2024 will be approximately 1.120 billion yuan, of which sales in urban public hospitals and county-level public hospitals will be 727 million yuan, sales in urban community centers and township health centers will be 167 million yuan, and sales in urban physical pharmacies and online pharmacies will be 226 million yuan.
4. Impact on the company and risk warning
The drug has obtained the "Drug Registration Certificate", which will further enrich the company's product line and help enhance the market competitiveness of the company's products. However, the sales of drugs may be affected by national policies, changes in the market environment and other factors, and are highly uncertain. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Beijing Fuyuan Pharmaceutical Co., Ltd.
September 5, 2025