• Following the European Commission (EC) approval of its insulin glargine injection (EU brand name: Ondibta^®), Gan & Lee Pharmaceuticals has now obtained EC marketing authorization for two rapid-acting insulin products: insulin lispro injection (EU brand name: Bysumlog^®) and insulin aspart injection (EU brand name: Dazparda^®). Collectively, these approvals mark the first China-developed rapid-acting insulin analogues to receive scientific validation from European regulatory authorities. Together with the earlier approval of insulin glargine, this achievement establishes Gan & Lee's comprehensive insulin portfolio in EU, covering both basal and prandial therapies to support full-spectrum glycemic control from fasting to postprandial conditions.

• Gan & Lee's insulin lispro and insulin aspart have demonstrated comparability with their respective reference products in pharmacokinetics (PK), pharmacodynamics (PD), and safety profiles based on comparative clinical studies¹. The availability of these products provides additional treatment options for healthcare professionals and patients in EU.

Beijing, China, May 15, 2026 — Gan & Lee Pharmaceuticals. (Gan & Lee, stock code: 603087.SH) , together with its European subsidiary Gan & Lee Pharmaceuticals Europe GmbH announced that its insulin lispro injection (EU brand name: Bysumlog^®) and insulin aspart injection (EU brand name: Dazparda^®) have recently received Commission Implementing Decision from the European Commission (EC) granting marketing authorization of Bysumlog^® and Dazparda^®. Bysumlog^® is indicated for the treatment of diabetes mellitus in adults and children; Dazparda^® is indicated for the treatment of diabetes mellitus in adults, adolescents, and children aged 1 year and older. This approval marks the official entry of both products into the European market, with a commercial launch planned across the European Union (EU), Iceland, Liechtenstein, and Norway.

According to the International Diabetes Federation (IDF) Diabetes Atlas, 11th Edition (2025), approximately 588.7 million adults aged 20–79 were living with diabetes worldwide in 2024. In Europe, the prevalence rate is estimated at 9.8%, corresponding to 65.6 million people—approximately 11.1% of the global diabetes population. Diabetes-related healthcare expenditure in Europe reached approximately USD 193 billion in 2024, with an average annual expenditure per patient of USD 2,951². These figures underscore the urgent need in the European market for safe, effective, and cost-efficient glucose-lowering treatment options.

Insulin aspart and insulin lispro are both rapid-acting insulin analogues, typically administered via subcutaneous injection shortly prior to meals. They are characterized by a rapid onset of action, an early peak effect, and a short duration of activity. By closely mimicking physiological postprandial insulin secretion, they enable effective control of postprandial glucose excursions.

At the molecular level, insulin aspart is generated by substituting proline at position B28 with aspartic acid, introducing charge repulsion that reduces molecular self-association. Insulin lispro is developed by reversing the positions of proline at B28 and lysine at B29, thereby altering molecular conformation and preventing self-aggregation. These structural modifications allow both analogues to rapidly dissociate into active monomers following subcutaneous administration, resulting in rapid onset and offset of action. In clinical practice, the two insulins demonstrate a high degree of similarity and are generally considered interchangeable in most patients.

Given their comparable efficacy and safety profiles, treatment selection is typically guided by individual patient needs, including dosing flexibility, treatment accessibility, patient preference, and cost considerations.

Subtle differences in pharmacokinetic (PK) profiles may further guide clinical use. Insulin lispro is associated with a slightly faster onset, earlier peak, and more rapid clearance, which may be advantageous for patients with shorter inter-meal interval or those engaging in postprandial physical activity, helping to reduce the risk of preprandial hypoglycemia. In contrast, insulin aspart has a marginally longer duration of action, which may be beneficial for patients with longer inter-meal intervals or those who frequently have delayed meals or snacks³.

Previously, Gan & Lee conducted randomized, double-blind Phase I bioequivalence clinical studies in Europe to evaluate the PK and pharmacodynamics (PD) of both products. The results demonstrated that Gan & Lee's insulin lispro (Bysumlog^®) and insulin aspart (Dazparda^®) are bioequivalent to their respective reference products in terms of PK/PD profiles, with comparable safety profiles¹.

Prandilin^®（Bysumlog^®4） has been on the market since 2007 as China's first domestically developed rapid-acting human insulin analogue. With nearly two decades of clinical use, its efficacy and safety have been well established, supporting its use in routine clinical practice and building a strong reputation both domestically and internationally. Rapilin^®（Dazparda^®5） has earned wide recognition from clinicians and patients for its excellent product performance since its launch in China in 2020, backed by a consistently positive market reputation and steady growth in both domestic and international sales.   

The simultaneous approval of Bysumlog^® and Dazparda^® in EU serves as direct validation that Gan & Lee's R&D and quality management systems are aligned with international standards. This milestone also makes Gan & Lee the first Chinese biopharmaceutical company to supply both long-acting and rapid-acting insulins for commercialization in the European market, delivering comprehensive coverage from basal to prandial insulin therapy.

Market Landscape for Insulin Lispro and Insulin Aspart in Europe

As of the date of this announcement, insulin lispro in Europe is primarily supplied by Eli Lilly. In 2024, Eli Lilly's global sales of insulin lispro reached approximately USD 2.325 billion.

Insulin aspart in Europe is primarily supplied by Novo Nordisk. 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).

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 exclusive 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 development, manufacturing and supply.

About Bysumlog^® (Insulin Lispro Injection)

Bysumlog^® (insulin lispro injection) is a rapid-acting human insulin analogue injection independently developed by Gan & Lee Pharmaceuticals. It is the first domestically developed rapid-acting human insulin analogue in China and has been marketed since 2007, with extensive clinical use in both domestic and international settings. Following amino acid modification of the insulin B-chain, insulin lispro demonstrates an onset of action within 10–15 minutes after subcutaneous injection, reaches peak activity at approximately 30–70 minutes, and has a duration of action of 2–5 hours. It may be administered within 15 minutes prior to a meal or immediately after a meal, supporting control of postprandial blood glucose levels and a relatively low risk of nocturnal hypoglycemia. Bysumlog^® has received marketing authorization from the European Commission.

About Dazparda^® (Insulin Aspart Injection)

Dazparda^® (insulin aspart injection) is a rapid-acting insulin analogue injection independently developed by Gan & Lee Pharmaceuticals and is the first domestically developed insulin aspart product approved in China. It is generated by substituting proline at position B28 of the human insulin molecule with aspartic acid. Following subcutaneous injection, insulin aspart has an onset of action within 10–20 minutes, reaches peak activity within 1–3 hours, and has a duration of action of 3–5 hours. It is administered immediately prior to a meal or shortly thereafter and supports control of postprandial blood glucose levels. Dazparda^® has received marketing authorization from the European Commission.

Notes:

1. 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.152817.

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

3.von Mach MA, Brinkmann C, Hansen T, Weilemann LS, Beyer J. Differences in pharmacokinetics and pharmacodynamics of insulin lispro and aspart in healthy volunteers. Exp Clin Endocrinol Diabetes. 2002 Nov;110(8):416-9. doi: 10.1055/s-2002-36428. PMID: 12518253.

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

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

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.