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Home / Company News / The Scientific Evaluation from EMA on the Marketing Authorisation Application of Gan & Lee Insulin Aspart biosimilar starts upon the Positive Validation Letter
The Scientific Evaluation from EMA on the Marketing Authorisation Application of Gan & Lee Insulin Aspart biosimilar starts upon the Positive Validation Letter

● Diabetes is a serious, chronic condition that occurs when the body cannot produce enough insulin or cannot effectively use the insulin it does produce (IDF 2021). According to the  data from Global Picture of IDF Diabetes Atlas (10th edition, 2021), there are currently 537 million adults (20-79 years old) living with diabetes worldwide. Without adequate response measures, the number of people with diabetes worldwide will reach 643 million by 2030 and 784 million by 20451.

Beijing, China/ Duesseldorf,Germany, Oct. 09, 2023—Gan & Lee Pharmaceuticals Europe GmbH, a wholly-owned subsidiary of Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee", stock code: 603087.SH) submitted the Marketing Authorization Application (hereinafter referred to as "MAA") of Insulin aspart biosimilar to the European Medicines Agency (hereinafter referred to as “EMA”), and recently received the Positive validation letter (formal acceptance notice)from the EMA, entering the review stage.

Before the MAA submission, a randomized, double-blind, comparative PK/PD study was completed in the EU, comparing the proposed biosimilar Gan & Lee Insulin Aspart Injection to the reference product NovoRapid®/Novolog®*. Based on the overall results of this trial, Gan & Lee Insulin Aspart Injection is equivalent to both EU-licensed NovoRapid® and US-authorized Novolog®.In 2022, Insulin Aaspart product NovoRapid® had global sales of DKK 15.46 billion (pprox.. USD 2.216 billion),including 5.318 billion DKK (about 762 million US dollars) in Europe2.

Kai.Du, CEO of Gan & Lee Pharmaceuticals, said, “Insulin aspart biosimilar developed by Gan & Lee Pharmaceuticals, was approved in 2020 as the first domestic insulin aspart in the Chinese market. Since then, it has received good market feedback and is being recognized and chosen by more doctors and patients. We expect that the three insulin products recently submitted in the EU will contribute to the improvement of insulin accessibility worldwide and bring benefits to more diabetic patients.”

Diabetes mellitus

Diabetes mellitus is a chronic health condition that affects how the body turns food into energy. With diabetes, the body doesn’t make enough insulin or can’t use it as well as it should. When there isn’t enough insulin or cells stop responding to insulin, too much glucose stays in the bloodstream. Over time, that can cause serious health problems, such as heart disease, vision loss, and kidney disease3.

Insulin Aspart

Insulin aspart is a rapid-acting insulin analog, which is modified to provide blood insulin within 10 to 20 minutes after subcutaneous injection. The maximum glucose-lowering effect of Insulin aspart occurrs between 1 and 3 hours after injection, and the effect of insulin aspart can last 3 to 5 hours. It can effectively control postprandial blood sugar. Insulin aspart should be injected before a meal or, if necessary, immediately after a meal. Insulin aspart shows the characteristics of rapid-action, short duration of action, and low risk of nocturnal hypoglycemia. It is usually used in regimen with long-acting insulin to achieve both basal and postprandial blood glucose control in patients with diabetes.

Cooperation with Sandoz AG

In 2018, Gan & Lee Pharmaceuticals signed a commercialization and supply agreement with Sandoz. Under the terms of the agreement, Sandoz has the right to commercialize the three Gan & Lee biosimilars upon approval in specific regions, including the United States, Europe, and other key territories. Gan & Lee is responsible for development (incl. clinical research) and supply.

* NovoRapid® and Novolog® are registered trademarks of Novo Nordisk authorized in EU and in in US respectively.


1.      IDF Diabetes Atlas 10th edition 2021. Available at: https://diabetesatlas.org/atlas/tenth-edition/

2.      Evaluate Pharma

3.      Centers for Disease Control and Prevention. Diabetes: what is diabetes. Available at: https://www.cdc.gov/diabetes/basics/diabetes.html

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have five recombinant insulin analogs commercialized in China including long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®).


In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics. 


This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “positive opinion,” “recommendation,” “proposed,” “potential,” “can,” “will,” “believe,” “committed,” “investigational,” “portfolio,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labelling for the investigational or approved biosimilar products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements.


Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Gan & Lee from selling its products; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors. Gan & Lee is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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