Hanyu Pharmaceutical: Announcement on the approval of the marketing application for the chemical raw material drug liraglutide of its wholly-owned subsidiary
Securities code: 300199 Securities abbreviation: Hanyu Pharmaceutical Announcement number: 2026-044 Shenzhen Hanyu Pharmaceutical Co., Ltd.
About the chemical raw material liraglutide, a wholly-owned subsidiary
Announcement of approval of listing application
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and contains no false records, misleading statements or major omissions.
Recently, Shenzhen Hanyu Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), a wholly-owned subsidiary of Hanyu Pharmaceutical (Wuhan) Co., Ltd., received the "Approval Notice for Marketing Application for Chemical APIs" issued by the State Food and Drug Administration. The relevant information is now announced as follows:
1. Basic information about drugs
Chemical API name: Liraglutide (H) (English name/Latin name: Liraglutide (H)) Chemical API registration standard number: YBY66522026
Validity period: 48 months
Packaging specifications: 1g/bag; 5g/bag; 10g/bag; 15g/bag; 50g/bag.
Application matters: Application for marketing of domestically produced chemical raw materials
Approval conclusion: 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, and the application for registration of this product is approved. The production process, quality standards and packaging labels are as attached.
Manufacturer: Hanyu Pharmaceutical (Wuhan) Co., Ltd.
The notification is valid until June 29, 2031
2. Drug-related situations
Liraglutide is an analog of human glucagon-like peptide-1 (GLP-1). The GLP-1 receptor is an important drug target and has multiple physiological functions such as blood glucose-dependent promotion of insulin secretion, protection of pancreatic beta cells, delaying gastric emptying and reducing appetite. This product is an API declared by the company through chemical synthesis. The company is the first domestic company to be approved for liraglutide through chemical synthesis.
3. Risk warning
Since pharmaceutical products have the characteristics of high technology, high risk, and high added value, the sales of this product after its launch will be affected by uncertain factors such as market and environmental changes, and there is a risk that sales will not meet expectations. Investors are advised to make prudent decisions and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Shenzhen Hanyu Pharmaceutical Co., Ltd.
July 7, 2026