• Approval by the European Commission (EC) represents a critical regulatory milestone for pharmaceutical products seeking entry into the international market. Gan & Lee Pharmaceuticals' independently developed insulin glargine injection is the first China-developed insulin glargine biosimilar to receive scientific validation from European regulatory authorities, underscoring the company's product development capabilities and quality management systems as fully aligned with international best-in-class standards.

• Independently developed by Gan & Lee Pharmaceuticals, the insulin glargine injection is a foundational long-acting basal insulin with more than two decades of global clinical use. It has now been registered in over 20 countries worldwide, including Brazil, Mexico and others.  Its proven efficacy and safety are supported not only by robust clinical and evidence-based medical data, but also by extensive real-world use, earning a high level of trust among patients and healthcare professionals across the globe.

Beijing, China, January 19th, 2026 — Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) and its European subsidiary Gan & Lee Pharmaceuticals Europe GmbH announced that its independently developed insulin glargine injection (EU brand name: Ondibta^®; China brand name: Basalin^®1) has recently received registration approval from the European Commission (EC) for the treatment of diabetes mellitus in adults, adolescents, and children aged 2 years and above. This approval marks the official entry of Gan & Lee's insulin glargine injection into the European market, with commercial launch planned across the European Union (EU), Iceland, Liechtenstein, and Norway.

Insulin glargine injection is a long-acting insulin analog, also known as a basal insulin analog. It is injected once daily, and after the onset of action, its effect can last for 24 hours. Insulin glargine has a long duration of action, a peakless plasma concentration, and steadily lowers blood glucose levels.

To date, Gan & Lee's insulin glargine injection is the first and only insulin glargine product developed in China to have completed head-to-head Phase III clinical studies om both Europe and the United States against Sanofi's reference product, Lantus^®. These pivotal studies, involving over 1,100 patients with diabetes(approximately 550 with T1DM and 550 with T2DM), demonstrated therapeutic equivalence between Basalin^® and Lantus^® in terms of efficacy and safety. 

Clinical demand and growth potential in the European diabetes treatment market continue to rise. According to the IDF Diabetes Atlas (11th Edition) published by the International Diabetes Federation (IDF), the number of people living with diabetes aged 20–79 years in Europe has reached 65.6 million, with related healthcare expenditures approaching USD 200 billion². This large patient population, coupled with substantial healthcare spending, underscores the region's urgent need for safe, effective, and cost-efficient treatment options.

As a long-acting insulin with more than two decades of clinical use and widespread global adoption, Gan&Lee's insulin glargine injection has demonstrated robust efficacy and safety, supported by both extensive clinical evidence and real-world data, and has earned broad recognition among patients and healthcare professionals worldwide. The successful approval of Ondibta^® for the EU market will provide European patients with an additional high-quality therapeutic option, further advancing local diabetes prevention and management.

This milestone also signifies that China's pharmaceutical industry, backed by strong innovation capabilities and manufacturing excellence, has received successful scientific validation from European authorities..

Dr. Wei Chen, Chairman and Chief Executive Officer of Gan & Lee Pharmaceuticals, commented:

"The approval of our independently developed insulin glargine injection—the first China-developed third-generation insulin biosimilar to be authorized in the European Union—represents a major milestone for the global expansion of China's biopharmaceutical industry. It marks the successful establishment of Gan & Lee's presence in the European market and constitutes a key step in our internationalization journey.

'Two decades of dedication sharpen the blade, and at last the plum blossom releases its fragrance.' This achievement is the result of our team's long-term commitment and perseverance, and it symbolizes the emerging global recognition of China's quality and innovation.

Looking ahead, we will continue to be driven by innovation and guided by quality, advancing more high-quality medicines from China to the global stage and ultimately benefiting patients worldwide."

Market landscape of insulin glargine in Europe

As of the date of announcement, in the European region, the main supplier of insulin glargine injection is Sanofi. As the originator company, Sanofi's insulin glargine product, Lantus^®, generated global sales of €2.855 billion (approximately $2.989 billion) in 2024, among which sales in Europe totaled €819 million (approximately $857 million; calculated using the euro to U.S. dollar exchange rate published by the State Administration of Foreign Exchange on December 31, 2024. Conversion rate 1:1.0469).

Cooperation with Sandoz

Gan & Lee entered into a commercial and supply agreement with Sandoz for three insulin analog products (Insulin Glargine, Insulin Lispro and Insulin Aspart in 2018 ). Under this agreement, following regulatory approval of the products, Sandoz has the right to commercialize the three Gan & Lee biosimilars upon approval in Europe, and other key territories, while Gan & Lee will be responsible for manufacturing supply.

Notes:

1. Basalin® is the brand name of Insulin Glargine Injection in China; Ondibta® is the brand name in the European Union.

2. IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/

About Gan & Lee

Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin^®), fast-acting lispro injection (Prandilin^™), fast-acting aspart injection (Rapilin^®), mixed protamine zinc lispro injection (25R) (Prandilin^™25), aspart 30 injection (Rapilin^®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^®).

In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets.

In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.