Recently, Gan & Lee Pharmaceuticals announced that the results of a Phase I clinical study conducted in China for its investigational insulin product, Insulin Glargine U300, have been successfully published in the internationally recognized academic journal Frontiers in Endocrinology. The study demonstrates that Gan & Lee’s Insulin Glargine U300 is highly similar to the reference product in terms of safety, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy subjects. Frontiers in Endocrinology is a globally respected academic journal in the field of endocrinology and metabolism, with a recent impact factor of 3.9 in 2023, 188,000 citations, and a ranking in the second quartile (Q2) by the Chinese Academy of Sciences, signifying its wide influence in the industry.

Insulin Glargine U300 (hereinafter referred to as “Glargine U300”) is a long-acting basal insulin, a concentrated version of Insulin Glargine U100. Compared to Insulin Glargine U100, Glargine U300 has a longer duration of action, lower day-to-day variability, and a reduced risk of hypoglycemia¹. Currently, in China, the only marketed Glargine U300 product is Sanofi's Toujeo^®. Gan & Lee’s investigational Glargine U300 is a proposed biosimilar to Toujeo^®. According to the regulations, the approval of biosimilars requires demonstrating a high degree of similarity in quality, safety, and efficacy to the already approved reference product². The euglycemic clamp technique is recognized as the most appropriate method for evaluating the similarity between insulin preparations, making it necessary to first conduct clamp studies in clinical trials of insulin biosimilars to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of the candidate biosimilar with the reference product³.

Therefore, Gan & Lee conducted a randomized, double-blind, single-center, Phase 1 euglycemic clamp clinical trial in China to evaluate the safety, PK, and PD bioequivalence of Gan & Lee’s Glargine U300 compared to the reference product Toujeo^® in healthy subjects. The primary PK endpoints were the area under the curve (AUC0-24h) and maximum concentration (Cmax) of the Glargine metabolite M1 over 24 hours post-administration. The primary PD endpoints were the area under the glucose infusion rate curve (AUCGIR0-24h) and maximum GIR (GIRmax) over 24 hours post-administration.

The article reports that in terms of PK and PD, Gan & Lee’s Glargine U300 showed comparable PK parameters and PD responses to Toujeo^®, with the 90% confidence intervals falling within the 80%-125% equivalence margin. Regarding safety, there were no significant differences between Gan & Lee’s Glargine U300 and Toujeo^®. The study results indicate that Gan & Lee’s Insulin Glargine U300 is bioequivalent to the reference product Toujeo^® in terms of safety, PK, and PD in healthy subjects.

Gan & Lee Pharmaceuticals’ CEO Kai Du stated: “This Phase 1 clinical study conducted in healthy subjects demonstrates the biosimilarity between Glargine U300 and the reference product Toujeo^®, providing real and reliable evidence for Glargine U300 as a biosimilar. As the latest product in Gan & Lee’s Insulin Glargine (Basalin^®) series, the positive clinical research results further validate the reliability of Gan & Lee’s Insulin Glargine quality. We will actively promote the early market launch of this product to provide more high-quality and affordable treatment options for diabetes patients.”

Link to the article：

https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1407829/full 

Reference：

1. Joshi SR, Singh G, Marwah A, Mittra S, Suvarna VR, Athalye SN. Comparative clinical efficacy and safety of insulin glargine 300 U/ml (Toujeo) versus insulin glargine 100 U/ml in type 2 diabetes and type 1 diabetes: A systematic literature review and meta-analysis. Diabetes Obes Metab. (2023). doi: 10.1111/dom.15007

2. SONG Li-na, XU Gang-ling, GE Yu-mei, TANG Chong-qi, XIE Song-mei. Quality Similarity Evaluation and Technical Requirement of Biosimilar Products[J]. Chinese Pharmaceutical Journal, 2022, 57(23): 1954-1961 https://doi.org/10.11669/cpj.2022.23.001

3. 国家药监局药审中心.《胰岛素类产品生物类似药药学研究与评价技术指导原则》的通告（2022年第22号）。2022.03.10

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 second overall and first among domestic 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.