Announcement on Obtaining the Drug Supplementary Application Approval Notice for Levothyroxine Sodium Tablets
Securities code: 601089 Securities abbreviation: Fuyuan Pharmaceutical Announcement number: Lin 2026-040
Beijing Fuyuan Pharmaceutical Co., Ltd.
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 Supplementary Application Approval Notice" (certificate number: 2026B04035) for Levothyroxine Sodium Tablets [Specification: 50 μg (calculated as levothyroxine sodium)] (hereinafter referred to as the "drug") issued by the State Food and Drug Administration (hereinafter referred to as the "NMPA"), approving the supplementary application for increasing the specification of the drug. The relevant information is now announced as follows:
1. Main contents of drug registration certificate
Generic name of the drug: Levothyroxine sodium tablets
Drug name English name/Latin name: Levothyroxine Sodium
Tablets
Dosage form tablet
Registration Classification Chemicals
Specification: 50μg (calculated as levothyroxine sodium)
Drug approval number: National Drug Approval Number H20269149
Drug registration standard number YBH19592026
Apply to increase the specification. The new specification is 50 μg (calculated based on levothyroxine sodium), which is related to changes in the excipients, production process, and
Registration standards.
According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product's application matters are in compliance with drug registration
According to the relevant requirements, the product was approved to increase the specification of 50 μg (based on levothyroxine sodium), and a new drug approval number was issued. At the same time, the excipient supplier, production process, registration standards, etc. were changed based on the original specifications. The changed production process, quality standards,
Instructions and labels are as attached.
Marketing authorization holder Beijing Fuyuan Pharmaceutical Co., Ltd.
Manufacturer Zhejiang Aisheng Pharmaceutical Co., Ltd.
2. Drug related information
Levothyroxine sodium tablets were developed by Merck and were first approved for marketing in France in June 1980. In July 1997, with the approval of the State Food and Drug Administration, levothyroxine sodium tablets were launched in China. This drug is suitable for the treatment of non-toxic goiter (normal thyroid function); prevention of recurrence of goiter after goiter resection; replacement treatment of hypothyroidism; adjuvant treatment of antithyroid drugs for the treatment of hyperthyroidism; suppression therapy after thyroid cancer surgery; thyroid suppression test.
The company received an application acceptance notice on March 30, 2026, and recently received approval from the State Food and Drug Administration. According to relevant national policies and regulations, obtaining the "Drug Supplementary Application Approval Notice" 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 the 50 μg specification of levothyroxine sodium for this drug is RMB 3.0837 million (unaudited).
3. Market status of similar drugs
According to data from Minai.com, the sales of levothyroxine sodium tablets in China's three major terminals and six major markets in 2025 will be approximately 1.40414 million yuan, of which the sales of urban public hospitals and county-level public hospitals will be 857.48 million yuan, the sales of urban community centers and township health centers will be 140.1 million yuan, and the sales of urban physical pharmacies and online pharmacies will be 406.56 million yuan.
4. Impact on the company and risk warning
The drug has obtained the "Notice of Approval of Drug Supplementary Application", 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.
July 2, 2026