Beijing Fuyuan Pharmaceutical Co., Ltd. Announcement on Obtaining Drug Registration Certificate for Benzbromarone Tablets
Securities code: 601089 Securities abbreviation: Fuyuan Pharmaceutical Announcement number: Lin 2026-038
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 "Drug Registration Certificate" (Certificate No.: 2026S02064) for Benzbromarone Tablets (specification: 50 mg) (hereinafter referred to as the "drug") issued by the State Food and Drug Administration (hereinafter referred to as the "NMPA"), 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: Benzbromarone Tablets
Drug name
English name/Latin name: Benzbromarone Tablets
Dosage form tablet
Registration classification: Chemicals Class 3
Specifications 50mg
Drug approval number: National Drug Approval Number H20264774
Drug registration standard number YBH15982026
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
According to the regulations, after review, this product meets the relevant approval conclusions for drug registration.
request, approve the registration, and issue a drug registration certificate. quality standard
The standards, instructions, labels and production processes are as attached.
Pharmaceutical manufacturing enterprises shall comply with pharmaceutical production quality management regulations
Production and sales can only be made upon specification requirements.
Marketing authorization holder Beijing Fuyuan Pharmaceutical Co., Ltd.
Manufacturer: Beijing Fuyuan Pharmaceutical Co., Ltd.
2. Drug related information
Benzbromarone tablets were developed by Sanofi and were first approved for marketing in France in the 1970s. It is one of the commonly used anti-gout drugs in clinical practice. The original research of benzbromarone tablets is not on the market in China. This drug is suitable for primary hyperuricemia and the intermittent period of gouty arthritis.
The company received an application acceptance notice on December 26, 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 5.5308 million (unaudited).
3. Market status of similar drugs
According to data from Minai.com, the sales of benzbromarone tablets in China's three major terminals and six major markets in 2025 are approximately 428.26 million yuan, of which urban public hospitals and county-level public hospitals have sales of 338.69 million yuan, urban community centers and township health centers have sales of 62.24 million yuan, and urban physical pharmacies and online pharmacies have sales of 27.33 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.
June 17, 2026