Beijing, China, November 13, 2025 — Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) and its European subsidiary Gan & Lee Pharmaceuticals Europe GmbH announced that Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of insulin glargine injection (pre-filled pen) (brand name: Ondibta^®) for treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above, as biosimilar to the reference medicine Lantus^® SoloStar^®1. 

The European Commission (EC) will review the positive CHMP opinion. Upon approval, Ondibta^® will be authorized for marketing across the European Union (EU), Iceland, Liechtenstein, and Norway.

Dr. Zifei Yuan, Executive Vice President and Chief Technology Officer of Gan & Lee, stated:

"The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Gan & Lee's commitment to its global strategy. We look forward to the formal approval of Ondibta^® in Europe, bring this high-quality and affordable treatment option to patients. Guided by the mission to delivering high-quality medicines and services to improve lives worldwide, Gan & Lee steadfastly adheres to a patient-centered development philosophy, intensifies investments in the R&D of innovative drugs, and endeavors to benefit global patient communities through enhanced therapeutic accessibility and affordable. The CHMP's recognition is undoubtedly the best tribute to the 20th anniversary of the launch of Basalin^®2. The EU is only the starting point — the world is our stage. We look forward to bringing more of Gan & Lee's innovative  achievements to patients worldwide, so that the strength of Chinese innovation can bring benefit people  around the globe." 

Europe remains one of the most important global pharmaceutical markets, demonstrating significant clinical demand and promising growth prospect in diabetes care. According to the IDF Diabetes Atlas 11th edition 2025, there are 65.6 million adults aged 20–79 living with diabetes in Europe, with related healthcare expenditure approaching USD 200 billion³. These figures underscore the growing need for safe, effective, and affordable treatment options in the region.

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 can steadily lower the blood glucose level.

To date, Gan & Lee's insulin glargine injection(brand name Ondibta^®)  is the first and only insulin glargine product developed in China to have completed head-to-head Phase III clinical studies in both Europe and the United States against Sanofi's reference product, Lantus^®. Theses pivotal studies, involving over 1,100 patients with diabetes (approxima tely 570 with T1DM and 580 with T2DM), demonstrated thera peutic biosimilarity between Ondibta^® and the reference medicine in terms of efficacy and safety.

Furthermore, using the glucose clamp technique, the gold standard for evaluating insulin pharmacokinetics and pharmacodynamics, Gan & Lee has also conducted and completed a head-to-head clinical study comparing its insulin glargine U300 with the reference product Toujeo^®4, confirming their biosimilarity in efficacy and safety.

As a classic long-acting basal insulin with over two decades of clinical use and extensive worldwide, Ondibta® has accumlated substantial pre-approval clinical evidence and  post-marketing real-world evidence, earning broad recognition and long-term trust among physicians and patients globally.

Gan & Lee's insulin glargine (Ondibta^®) is poised to enter the EU market for commercialization, providing European patients with a new, high-quality treatment option and contributing positively to the overall advancement of diabetes care and management in the region.

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 worldwide

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

Notes:

1. Lantus^® SoloStar^® are registered trademarks of Sanofi.

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

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

4. Toujeo^® is a registered trademark of Sanofi.

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, with the disposable pen needle (GanleeFine^®) approved by the US Food and Drug Administration (FDA) in 2020 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.