Announcement on Insulin Glargine Injection Obtaining Marketing Authorization from the European Commission
Securities code: 603087 Securities abbreviation: Ganli Pharmaceutical Announcement number: 2026-004
Ganli 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.
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company", "Gan & Lee Pharmaceuticals") and its European wholly-owned subsidiary Gan & Lee Pharmaceuticals Europe GmbH (hereinafter referred to as "Gan & Lee Europe") have recently received approval from the European Commission (European Commission (EC) notified that the company's product insulin glargine injection (trade name: Ondibta®) has obtained marketing authorization in the European Union, Iceland, Liechtenstein and Norway, and is suitable for the treatment of diabetes in adults, adolescents and children aged 2 years and above. The relevant information is now announced as follows:
1. Basic information about drugs
Drug name: Ondibta®
Generic name of the drug: Insulin glargine
Indications: diabetes
Dosage form: injection
Specifications: 3ml: 100 units/ml (pre-filled injection pen)
Marketing authorization holder: Ganli Pharmaceuticals Europe Co., Ltd.
2. Other related information about drugs
Insulin glargine is a basal long-acting insulin that is injected subcutaneously once a day, and its hypoglycemic effect lasts for 24 hours. It has the characteristics of long action time, stable peak-free blood concentration and stable glucose control.
The latest data released by the International Diabetes Federation (IDF) Global Diabetes Overview 11th Edition (2025) shows that there will be approximately 588.7 million people with diabetes aged 20-79 in the world in 2024, of which 65.6 million will be patients aged 20-79 in Europe, accounting for approximately 11.1% of the global patient population; the total medical expenditure due to diabetes is US$1.93 billion (the global total expenditure is 1.015 trillion US dollars), the annual diabetes-related expenditure per patient is US$2,951; among the adult population aged 20-79 years in Europe, the incidence of diabetes is 9.8%.
As of the date of the announcement, the main supplier of insulin glargine injection in Europe is Sanofi. As an original manufacturer, Sanofi's global sales of insulin glargine products in 2024 will be 2.855 billion euros (approximately US$2.989 billion), of which sales in Europe will be 819 million euros (approximately US$857 million; converted using the euro-to-US dollar conversion rate announced by the State Administration of Foreign Exchange on December 31, 2024, with a conversion rate of 1:1.0469).
As of September 30, 2025, Gan & Lee Pharmaceuticals had invested a total of RMB 936 million in research and development expenses on the insulin glargine project.
3. Risk warning
Insulin glargine injection (trade name: Ondibta®) has been approved for marketing by the European Commission, which will effectively expand the company's international market layout and further enhance the international influence of the product.
This approval indicates that the company can import and sell related products in the European Union, Iceland, Liechtenstein and Norway. However, due to factors such as changes in market demand, changes in policy environment, exchange rate fluctuations, market competition, etc., the expansion progress and sales scale of related products in the above regions 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 Ganli Pharmaceutical Co., Ltd.
January 15, 2026