Beijing, China, February 26, 2026 — 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 granting of a marketing authorisation for its biosimilar insulin lispro injection (EU brand name: Bysumlog^®; China brand name: Prandilin^®1) for the treatment of diabetes mellitus in adults and children, and insulin aspart injection (EU brand name: Dazparda^®; China brand name: Rapilin^®2) for the treatment of diabetes mellitus in adults, adolescents, and children aged 1 year and older. The European Commission (EC) will adopt a final decision based on the CHMP positive opinion. Upon approval, Bysumlog^® and Dazparda^® will be authorized for marketing across the European Union (EU), Iceland, Liechtenstein, and Norway.

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 lispro is a rapid-acting insulin analogue. Following molecular modification, it demonstrates a rapid onset of action within 10–15 minutes of subcutaneous injection, reaches a peak effect at approximately 30–70 minutes post-administration, and has a duration of action of 2–5 hours, enabling effective control of postprandial blood glucose levels. It may be administered shortly before meals and, if necessary, shortly after meals. To validate the safety profiles of its insulin lispro for global use, Gan & Lee previously conducted a randomized, double-blind Phase 1 comparative clinical study in Europe to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of its insulin lispro. The study results demonstrated the biosimilarity between Gan & Lee insulin lispro (Bysumlog^®) and the reference product Humalog^® in PK/PD profiles⁴, with comparable safety profiles⁵.

Insulin aspart is a rapid-acting insulin analogue in which the proline at position B28 of the human insulin amino acid chain is replaced with aspartic acid, accelerating the rate of subcutaneous absorption. Following subcutaneous injection, Insulin aspart has an onset of action within 10–20 minutes, reaches a peak effect within 1–3 hours post-administration, and has a duration of action of 3–5 hours, enabling effective control of postprandial blood glucose levels. It is generally administered immediately before meals and, if required, shortly after meals. To validate the safety profiles of its insulin aspart for global use, Gan & Lee has likewise completed a randomized, double-blind Phase I PK/PD comparative study in Europe. The results demonstrated the biosimilarity between Gan & Lee insulin aspart (Dazparda^®) and the reference products NovoLog^®/NovoRapid^® in PK/PD profiles⁶, with a comparable safety profile⁵. 

As China's first domestically developed rapid-acting insulin analog, Prandilin^® has been on the market since 2007. Backed by nearly 20 years of extensive clinical use, its efficacy and safety have been well established, earning broad clinical validation and strong market trust. Launched in China in 2020, Rapilin^® has also demonstrated robust clinical performance and sustained sales growth, winning wide recognition from clinicians and patients alike. The positive opinion issued by the CHMP has laid a solid foundation for the potential entry of both products into the European Union market. This milestone is set to deliver additional high-quality treatment options for European patients while also providing freshness into the comprehensive management of diabetes across the region.

Market Landscape for Insulin Lispro and Insulin Aspart in Europe

As of the date of announcement, in the European region, the main supplier of insulin lispro injection is Eli Lilly. In 2024, Eli Lilly's global sales of insulin lispro reached approximately USD 2.325 billion. As of September 30, 2025, Gan & Lee has invested approximately USD 58.84 million in research and development (R&D) for its insulin lispro program, based on the exchange rate released by the State Administration of Foreign Exchange as of January 30, 2026 (CNY:USD = 1:0.1435).

Novo Nordisk is the primary supplier of insulin aspart injection for the European market. In 2025, Novo Nordisk's global sales of insulin aspart products totaled approximately USD 2.524 billion, based on the exchange rate released by the State Administration of Foreign Exchange as of January 30, 2026 (DKK:USD = 1:0.1601). As of September 30, 2025, Gan & Lee has made cumulative R&D investments of approximately USD 30.42 million for its insulin aspart program, based on the exchange rate released by the State Administration of Foreign Exchange as of January 30, 2026 (CNY:USD = 1:0.1435).

Cooperation with Sandoz worldwide

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

Notes:

1. Prandilin^® is the brand name of Insulin Lispro Injection in China; Bysumlog^® is the brand name for Insulin Lispro in the EU.

2. Rapilin^® is the brand name of Insulin Aspart Injection in China; Dazparda^® is the brand name for Insulin Aspart in the EU.

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

4. Humalog^® is a registered trademark of Eli Lilly and Company for its Insulin Lispro.

5. Chen W, Lu J, Plum-Mörschel L, et al. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin^®), lispro (prandilin^®) and glargine (basalin^®) with EU- und US-sourced reference insulins. Diabetes Obes Metab. 2023;25(12):3817-3825. doi:10.1111/dom.15281

6. Novolog^® and NovoRapid^® are registered trademarks of Novo Nordisk A/S for its Insulin Aspart in the US and Europe, respectively.

About Gan & Lee

Gan & Lee Pharmaceuticals is a high-tech biopharmaceutical company and the first in China to master industrial-scale manufacturing technologies for recombinant insulin analogs. The Company has established a comprehensive insulin research and development pipeline.

Currently, Gan & Lee offers six core insulin products, including five insulin analogs: insulin glargine injection (Basalin^®; EU brand name Ondibta^®), insulin lispro injection (Prandilin^®; EU brand name: Bysumlog^®), insulin aspart injection (Rapilin^®; EU brand name: Dazparda^®), premixed insulin lispro protamine suspension injection (25R) (Prandilin^®25), and insulin aspart 30 injection (Rapilin^®30); as well as one human insulin product, premixed human insulin protamine suspension injection (30R) (Similin^®30), together with related delivery devices. These products cover the long-acting, rapid-acting, and premixed insulins.

In China's second round of national volume-based procurement for insulin, Gan & Lee ranked first among selected companies by contracted volume for insulin analogs, further strengthening its domestic market position. In parallel, the Company continues to advance its international expansion. Insulin glargine injection has received marketing authorization from the European Commission (EC), while for insulin lispro injection and insulin aspart injection, it has received the positive opinion from CHMP of EMA. Gan & Lee is steadily progressing toward its goal of becoming a key global participant in the field of metabolic diseases.

Looking forward, Gan & Lee is committed to achieving comprehensive coverage across the diabetes treatment landscape and further enhancing its competitive position in this therapeutic area. The Company will also actively pursue the development of innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, and other therapeutic areas.